[Title 21 CFR ]
[Code of Federal Regulations (annual edition) - April 1, 2000 Edition]
[From the U.S. Government Printing Office]



[[Page i]]

          

                    21


          Parts 800 to 1299

                         Revised as of April 1, 2000

Food and Drugs





          Containing a Codification of documents of general 
          applicability and future effect
          As of April 1, 2000
          With Ancillaries
          Published by
          Office of the Federal Register
          National Archives and Records
          Administration

As a Special Edition of the Federal Register



[[Page ii]]

                                      




                     U.S. GOVERNMENT PRINTING OFFICE
                            WASHINGTON : 2000



               For sale by U.S. Government Printing Office
 Superintendent of Documents, Mail Stop: SSOP, Washington, DC 20402-9328



[[Page iii]]




                            Table of Contents



                                                                    Page
  Explanation.................................................       v

  Title 21:
          Chapter I--Food and Drug Administration, Department 
          of Health and Human Services (Continued)                   3
  Finding Aids:
      Material Approved for Incorporation by Reference........     669
      Table of CFR Titles and Chapters........................     671
      Alphabetical List of Agencies Appearing in the CFR......     689
      List of CFR Sections Affected...........................     699



[[Page iv]]


      


                     ----------------------------

                     Cite this Code:  CFR
                     To cite the regulations in 
                       this volume use title, 
                       part and section number. 
                       Thus, 21 CFR 800.10 refers 
                       to title 21, part 800, 
                       section 10.

                     ----------------------------

[[Page v]]



                               EXPLANATION

    The Code of Federal Regulations is a codification of the general and 
permanent rules published in the Federal Register by the Executive 
departments and agencies of the Federal Government. The Code is divided 
into 50 titles which represent broad areas subject to Federal 
regulation. Each title is divided into chapters which usually bear the 
name of the issuing agency. Each chapter is further subdivided into 
parts covering specific regulatory areas.
    Each volume of the Code is revised at least once each calendar year 
and issued on a quarterly basis approximately as follows:

Title 1 through Title 16.................................as of January 1
Title 17 through Title 27..................................as of April 1
Title 28 through Title 41...................................as of July 1
Title 42 through Title 50................................as of October 1

    The appropriate revision date is printed on the cover of each 
volume.

LEGAL STATUS

    The contents of the Federal Register are required to be judicially 
noticed (44 U.S.C. 1507). The Code of Federal Regulations is prima facie 
evidence of the text of the original documents (44 U.S.C. 1510).

HOW TO USE THE CODE OF FEDERAL REGULATIONS

    The Code of Federal Regulations is kept up to date by the individual 
issues of the Federal Register. These two publications must be used 
together to determine the latest version of any given rule.
    To determine whether a Code volume has been amended since its 
revision date (in this case, April 1, 2000), consult the ``List of CFR 
Sections Affected (LSA),'' which is issued monthly, and the ``Cumulative 
List of Parts Affected,'' which appears in the Reader Aids section of 
the daily Federal Register. These two lists will identify the Federal 
Register page number of the latest amendment of any given rule.

EFFECTIVE AND EXPIRATION DATES

    Each volume of the Code contains amendments published in the Federal 
Register since the last revision of that volume of the Code. Source 
citations for the regulations are referred to by volume number and page 
number of the Federal Register and date of publication. Publication 
dates and effective dates are usually not the same and care must be 
exercised by the user in determining the actual effective date. In 
instances where the effective date is beyond the cut-off date for the 
Code a note has been inserted to reflect the future effective date. In 
those instances where a regulation published in the Federal Register 
states a date certain for expiration, an appropriate note will be 
inserted following the text.

OMB CONTROL NUMBERS

    The Paperwork Reduction Act of 1980 (Pub. L. 96-511) requires 
Federal agencies to display an OMB control number with their information 
collection request.

[[Page vi]]

Many agencies have begun publishing numerous OMB control numbers as 
amendments to existing regulations in the CFR. These OMB numbers are 
placed as close as possible to the applicable recordkeeping or reporting 
requirements.

OBSOLETE PROVISIONS

    Provisions that become obsolete before the revision date stated on 
the cover of each volume are not carried. Code users may find the text 
of provisions in effect on a given date in the past by using the 
appropriate numerical list of sections affected. For the period before 
January 1, 1986, consult either the List of CFR Sections Affected, 1949-
1963, 1964-1972, or 1973-1985, published in seven separate volumes. For 
the period beginning January 1, 1986, a ``List of CFR Sections 
Affected'' is published at the end of each CFR volume.

INCORPORATION BY REFERENCE

    What is incorporation by reference? Incorporation by reference was 
established by statute and allows Federal agencies to meet the 
requirement to publish regulations in the Federal Register by referring 
to materials already published elsewhere. For an incorporation to be 
valid, the Director of the Federal Register must approve it. The legal 
effect of incorporation by reference is that the material is treated as 
if it were published in full in the Federal Register (5 U.S.C. 552(a)). 
This material, like any other properly issued regulation, has the force 
of law.
    What is a proper incorporation by reference? The Director of the 
Federal Register will approve an incorporation by reference only when 
the requirements of 1 CFR part 51 are met. Some of the elements on which 
approval is based are:
    (a) The incorporation will substantially reduce the volume of 
material published in the Federal Register.
    (b) The matter incorporated is in fact available to the extent 
necessary to afford fairness and uniformity in the administrative 
process.
    (c) The incorporating document is drafted and submitted for 
publication in accordance with 1 CFR part 51.
    Properly approved incorporations by reference in this volume are 
listed in the Finding Aids at the end of this volume.
    What if the material incorporated by reference cannot be found? If 
you have any problem locating or obtaining a copy of material listed in 
the Finding Aids of this volume as an approved incorporation by 
reference, please contact the agency that issued the regulation 
containing that incorporation. If, after contacting the agency, you find 
the material is not available, please notify the Director of the Federal 
Register, National Archives and Records Administration, Washington DC 
20408, or call (202) 523-4534.

CFR INDEXES AND TABULAR GUIDES

    A subject index to the Code of Federal Regulations is contained in a 
separate volume, revised annually as of January 1, entitled CFR Index 
and Finding Aids. This volume contains the Parallel Table of Statutory 
Authorities and Agency Rules (Table I). A list of CFR titles, chapters, 
and parts and an alphabetical list of agencies publishing in the CFR are 
also included in this volume.
    An index to the text of ``Title 3--The President'' is carried within 
that volume.
    The Federal Register Index is issued monthly in cumulative form. 
This index is based on a consolidation of the ``Contents'' entries in 
the daily Federal Register.
    A List of CFR Sections Affected (LSA) is published monthly, keyed to 
the revision dates of the 50 CFR titles.

[[Page vii]]


REPUBLICATION OF MATERIAL

    There are no restrictions on the republication of material appearing 
in the Code of Federal Regulations.

INQUIRIES

    For a legal interpretation or explanation of any regulation in this 
volume, contact the issuing agency. The issuing agency's name appears at 
the top of odd-numbered pages.
    For inquiries concerning CFR reference assistance, call 202-523-5227 
or write to the Director, Office of the Federal Register, National 
Archives and Records Administration, Washington, DC 20408.

SALES

    The Government Printing Office (GPO) processes all sales and 
distribution of the CFR. For payment by credit card, call 202-512-1800, 
M-F, 8 a.m. to 4 p.m. e.s.t. or fax your order to 202-512-2233, 24 hours 
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Customer Service call 202-512-1803.

ELECTRONIC SERVICES

    The full text of the Code of Federal Regulations, the LSA (List of 
CFR Sections Affected), The United States Government Manual, the Federal 
Register, Public Laws, Weekly Compilation of Presidential Documents and 
the Privacy Act Compilation are available in electronic format at 
www.access.gpo.gov/nara (``GPO Access''). For more information, contact 
Electronic Information Dissemination Services, U.S. Government Printing 
Office. Phone 202-512-1530, or 888-293-6498 (toll-free). E-mail, 
gpoaccess@gpo.gov.
    The Office of the Federal Register also offers a free service on the 
National Archives and Records Administration's (NARA) World Wide Web 
site for public law numbers, Federal Register finding aids, and related 
information. Connect to NARA's web site at www.nara.gov/fedreg. The NARA 
site also contains links to GPO Access.

                              Raymond A. Mosley,
                                    Director,
                          Office of the Federal Register.

April 1, 2000.



[[Page ix]]



                               THIS TITLE

    Title 21--Food and Drugs is composed of nine volumes. The parts in 
these volumes are arranged in the following order: Parts 1-99, 100-169, 
170-199, 200-299, 300-499, 500-599, 600-799, 800-1299 and 1300-end. The 
first eight volumes, containing parts 1-1299, comprise Chapter I--Food 
and Drug Administration, Department of Health and Human Services. The 
ninth volume, containing part 1300 to end, includes Chapter II--Drug 
Enforcement Administration, Department of Justice, and Chapter III--
Office of National Drug Control Policy. The contents of these volumes 
represent all current regulations codified under this title of the CFR 
as of April 1, 2000.

    Redesignation tables for Chapter I--Food and Drug Administration 
appear in the Finding Aids section for the volumes containing parts 170-
199 and 500-599.

    For this volume, Cheryl E. Sirofchuck was Chief Editor. The Code of 
Federal Regulations publication program is under the direction of 
Frances D. McDonald, assisted by Alomha S. Morris.

[[Page x]]





[[Page 1]]



                        TITLE 21--FOOD AND DRUGS




                 (This book contains Parts 800 to 1299)

  --------------------------------------------------------------------
                                                                    Part

chapter i--Food and Drug Administration, Department of 
  Health and Human Services (Continued).....................         800

Cross References: Food Safety and Inspection Service, Department of 
  Agriculture: See 9 CFR chapter III.

  Federal Trade Commission: See Commercial Practices, 16 CFR chapter I.

  U.S. Customs Service, Department of the Treasury: See Customs Duties, 
19 CFR chapter I.

  Internal Revenue Service, Department of the Treasury: See Internal 
Revenue, 26 CFR chapter I. Bureau of Alcohol, Tobacco, and Firearms, 
Department of the Treasury: See Alcohol, Tobacco Products and Firearms, 
27 CFR chapter I.

[[Page 3]]



                CHAPTER I--FOOD AND DRUG ADMINISTRATION,






                     DEPARTMENT OF HEALTH AND HUMAN






                          SERVICES--(Continued)




  --------------------------------------------------------------------

                      SUBCHAPTER H--MEDICAL DEVICES
Part                                                                Page
800             General.....................................           5
801             Labeling....................................          13
803             Medical device reporting....................          38
806             Medical devices; reports of corrections and 
                    removals................................          55
807             Establishment registration and device 
                    listing for manufacturers and initial 
                    importers of devices....................          59
808             Exemptions from Federal preemption of State 
                    and local medical device requirements...          74
809             In vitro diagnostic products for human use..          84
810             Medical device recall authority.............          90
812             Investigational device exemptions...........          97
813             [Reserved]

814             Premarket approval of medical devices.......         115
820             Quality system regulation...................         137
821             Medical device tracking requirements........         150
860             Medical device classification procedures....         156
861             Procedures for performance standards 
                    development.............................         168
862             Clinical chemistry and clinical toxicology 
                    devices.................................         172
864             Hematology and pathology devices............         209
866             Immunology and microbiology devices.........         230
868             Anesthesiology devices......................         266
870             Cardiovascular devices......................         286
872             Dental devices..............................         306
874             Ear, nose, and throat devices...............         330
876             Gastroenterology-urology devices............         342
878             General and plastic surgery devices.........         359
880             General hospital and personal use devices...         373
882             Neurological devices........................         390

[[Page 4]]

884             Obstetrical and gynecological devices.......         406
886             Ophthalmic devices..........................         427
888             Orthopedic devices..........................         449
890             Physical medicine devices...................         473
892             Radiology devices...........................         489
895             Banned devices..............................         502
898             Performance standard for electrode lead 
                    wires and patient cables................         507
             SUBCHAPTER I--MAMMOGRAPHY QUALITY STANDARDS ACT
900             Mammography.................................         509
                    SUBCHAPTER J--RADIOLOGICAL HEALTH
1000            General.....................................         541
1002            Records and reports.........................         550
1003            Notification of defects or failure to comply         559
1004            Repurchase, repairs, or replacement of 
                    electronic products.....................         562
1005            Importation of electronic products..........         564
1010            Performance standards for electronic 
                    products: General.......................         568
1020            Performance standards for ionizing radiation 
                    emitting products.......................         573
1030            Performance standards for microwave and 
                    radio frequency emitting products.......         602
1040            Performance standards for light-emitting 
                    products................................         605
1050            Performance standards for sonic, infrasonic, 
                    and ultrasonic radiation-emitting 
                    products................................         629
                        SUBCHAPTER K  [RESERVED]
 SUBCHAPTER L--REGULATIONS UNDER CERTAIN OTHER ACTS ADMINISTERED BY THE 
                      FOOD AND DRUG ADMINISTRATION
1210            Regulations under the Federal Import Milk 
                    Act.....................................         633
1230            Regulations under the Federal Caustic Poison 
                    Act.....................................         636
1240            Control of communicable diseases............         643
1250            Interstate conveyance sanitation............         651
1251-1269

  [Reserved]

1270            Human tissue intended for transplantation...         661
1271-1299

  [Reserved]

[[Page 5]]





                      SUBCHAPTER H--MEDICAL DEVICES





PART 800--GENERAL--Table of Contents




Subpart A [Reserved]

          Subpart B--Requirements for Specific Medical Devices

Sec.
800.10  Contact lens solutions; sterility.
800.12  Contact lens solutions and tablets; tamper-resistant packaging.
800.20  Patient examination gloves and surgeons' gloves; sample plans 
          and test method for leakage defects; adulteration.

           Subpart C--Administrative Practices and Procedures

800.55  Administrative detention.

    Authority:  21 U.S.C. 321, 334, 351, 352, 355, 360e, 360i, 360k, 
361, 362, 371.

Subpart A  [Reserved]



          Subpart B--Requirements for Specific Medical Devices



Sec. 800.10  Contact lens solutions; sterility.

    (a)(1) Informed medical opinion is in agreement that all 
preparations offered or intended for ophthalmic use, including contact 
lens solutions, should be sterile. It is further evident that such 
preparations purport to be of such purity and quality as to be suitable 
for safe use in the eye.
    (2) The Food and Drug Administration concludes that all such 
preparations, if they are not sterile, fall below their professed 
standard of purity or quality and may be unsafe. In a statement of 
policy issued on September 1, 1964, the Food and Drug Administration 
ruled that liquid preparations offered or intended for ophthalmic use 
that are not sterile may be regarded as adulterated within the meaning 
of section 501(c) of the Federal Food, Drug, and Cosmetic Act (the act), 
and, further, may be deemed misbranded within the meaning of section 
502(j) of the act. By this regulation, this ruling is applicable to all 
preparations for ophthalmic use that are regulated as medical devices, 
i.e., contact lens solutions. By the regulation in Sec. 200.50 of this 
chapter, this ruling is applicable to ophthalmic preparations that are 
regulated as drugs.
    (3) The containers shall be sterile at the time of filling and 
closing, and the container or individual carton shall be so sealed that 
the contents cannot be used without destroying the seal. The packaging 
and labeling of these solutions shall also comply with Sec. 800.12 on 
tamper-resistant packaging requirements.
    (b) Liquid ophthalmic preparations packed in multiple-dose 
containers should:
    (1) Contain one or more suitable and harmless substances that will 
inhibit the growth of microorganisms; or
    (2) Be so packaged as to volume and type of container and so labeled 
as to duration of use and with such necessary warnings as to afford 
adequate protection and minimize the hazard of injury resulting from 
contamination during use.
    (c) Eye cups, eye droppers, and other dispensers intended for 
ophthalmic use should be sterile, and may be regarded as falling below 
their professed standard of purity or quality if they are not sterile. 
These articles, which are regulated as medical devices unless packaged 
with the drugs with which they are to be used, should be packaged so as 
to maintain sterility until the package is opened and be labeled, on or 
within the retail package, so as to afford adequate directions and 
necessary warnings to minimize the hazard of injury resulting from 
contamination during use.

[47 FR 50455, Nov. 5, 1982]



Sec. 800.12  Contact lens solutions and tablets; tamper-resistant packaging.

    (a) General. Unless contact lens solutions used, for example, to 
clean, disinfect, wet, lubricate, rinse, soak, or store contact lenses 
and salt tablets or other dosage forms to be used to make any such 
solutions are packaged in tamper-resistant retail packages, there is the 
opportunity for the malicious adulteration of these products with

[[Page 6]]

risks both to individuals who unknowingly purchase adulterated products 
and with loss of consumer confidence in the security of the packages of 
over-the-counter (OTC) health care products. The Food and Drug 
Administration has the authority and responsibility under the Federal 
Food, Drug, and Cosmetic Act (the act) to establish a uniform national 
standard for tamper-resistant packaging of those OTC products vulnerable 
to malicious adulteration that will improve the security of OTC 
packaging and help assure the safety and effectiveness of the products 
contained therein. A contact lens solution or tablet or other dosage 
form to be used to make such a solution for retail sale that is not 
packaged in a tamper-resistant package and labeled in accordance with 
this section is adulterated under section 501 of the act or misbranded 
under section 502 of the act, or both.
    (b) Requirement for tamper-resistant package. Each manufacturer and 
packer who packages for retail sale a product regulated as a medical 
device that is a solution intended for use with contact lenses, e.g., 
for cleaning, disinfecting, wetting, lubricating, rinsing, soaking, or 
storing contact lenses or tablets or other dosage forms to be used to 
make any such solution shall package the product in a tamper-resistant 
package, if this product is accessible to the public while held for 
sale. A tamper-resistant package is one having an indicator or barrier 
to entry which, if breached or missing, can reasonably be expected to 
provide visible evidence to consumers that tampering has occurred. To 
reduce the likelihood of substitution of a tamper-resistant feature 
after tampering, the indicator or barrier to entry is required to be 
distinctive by design or by the use of an identifying characteristic 
(e.g., a pattern, name, registered trademark, logo, or picture). For 
purposes of this section, the term ``distinctive by design'' means the 
package cannot be duplicated with commonly available material or through 
commonly available processes. A tamper-resistant package may involve an 
immediate-container and closure system or secondary-container or carton 
system or any combination of systems intended to provide a visual 
indication of package integrity. The tamper-resistant feature shall be 
designed to and shall remain intact when handled in a reasonable manner 
during manufacture, distribution, and retail display.
    (c) Labeling. Each retail package of a product covered by this 
section is required to bear a statement that is prominently placed so 
that consumers are alerted to the tamper-resistant feature of the 
package. The labeling statement is also required to be so placed that it 
will be unaffected if the tamper-resistant feature of the package is 
breached or missing. If the tamper-resistant feature chosen to meet the 
requirement in paragraph (b) of this section is one that uses an 
identifying characteristic, that characteristic is required to be 
referred to in the labeling statement. For example, the labeling 
statement on a bottle with a shrink band could say ``For your 
protection, this bottle has an imprinted seal around the neck.''
    (d) Requests for exemptions from packaging and labeling 
requirements. A manufacturer or packer may request an exemption from the 
packaging and labeling requirements of this section. A request for an 
exemption is required to be submitted in the form of a citizen petition 
under Sec. 10.30 of this chapter and should be clearly identified on the 
envelope as a ``Request for Exemption from Tamper-resistant Rule.'' A 
petition for an exemption from a requirement of this section is required 
to contain the same kind of information about the product as is 
specified for OTC drugs in Sec. 211.132(d) of this chapter. This 
information collection requirement has been approved by the Office of 
Management and Budget under number 0910-0150.
    (e) Products subject to approved premarket approval applications. 
Holders of approved premarket approval applications for products subject 
to this section are required to submit supplements to provide for 
changes in packaging to comply with the requirement of paragraph (b) of 
this section unless these changes do not affect the composition of the 
container, the torque (tightness) of the container, or the composition 
of the closure component in contact with the contents (cap liner

[[Page 7]]

or innerseal) as these features are described in the approved premarket 
approval application. Any supplemental premarket approval application 
under this paragraph is required to include data sufficient to show that 
these changes do not adversely affect the product.
    (f) Effective date. Each product subject to this section is required 
to comply with the requirements of this section on the dates listed 
below except to the extent that a product's manufacturer or packer has 
obtained an exemption from a packaging or labeling requirement:
    (1) Initial effective date for packaging requirements. (i) The 
packaging requirement in paragraph (b) of this section is effective on 
February 7, 1983 for each contact lens solution packaged for retail sale 
on or after that date, except for the requirement in paragraph (b) of 
this section for a distinctive indicator or barrier to entry.
    (ii) The packaging requirement in paragraph (b) of this section is 
effective on May 5, 1983 for each tablet that is to be used to make a 
contact lens solution and that is packaged for retail sale on or after 
that date.
    (2) Initial effective date for labeling requirements. The 
requirement in paragraph (b) of this section that the indicator or 
barrier to entry be distinctive by design and the requirement in 
paragraph (c) of this section for a labeling statement are effective on 
May 5, 1983 for each product subject to this section packaged for retail 
sale on or after that date, except that the requirement for a specific 
label reference to any identifying characteristic is effective on 
February 6, 1984 for each affected product subject to this section 
packaged for retail sale on or after that date.
    (3) Retail level effective date. The tamper-resistant packaging 
requirement of paragraph (b) of this section is effective on February 6, 
1984 for each product subject to this section that is held for sale at 
retail level on or after that date that was packaged for retail sale 
before May 5, 1983. This does not include the requirement in paragraph 
(b) of this section that the indicator or barrier to entry be 
distinctive by design. Products packaged for retail sale after May 5, 
1983, are required to be in compliance with all aspects of the 
regulations without regard to the retail level effective date.

[47 FR 50455, Nov. 5, 1982; 48 FR 1706, Jan. 14, 1983, as amended at 48 
FR 16666, Apr. 19, 1983; 48 FR 37625, Aug. 19, 1983; 53 FR 11252, Apr. 
6, 1988]

    Effective Date Note:  A document published at 48 FR 41579, Sept. 16, 
1983, stayed the effective date of Sec. 800.12(f)(3) until further 
notice.



Sec. 800.20  Patient examination gloves and surgeons' gloves; sample plans and test method for leakage defects; adulteration.

    (a) Purpose. The prevalence of human immunodeficiency virus (HIV), 
which causes acquired immune deficiency syndrome (AIDS), and its risk of 
transmission in the health care context, have caused the Food and Drug 
Administration (FDA) to look more closely at the quality control of 
barrier devices, such as surgeons' gloves and patient examination gloves 
(collectively known as medical gloves) to reduce the risk of 
transmission of HIV and other blood-borne infectious diseases. The 
Centers for Disease Control (CDC) recommend that health care workers 
wear medical gloves to reduce the risk of transmission of HIV and other 
blood-borne infectious deseases. The CDC recommends that health care 
workers wear medical gloves when touching blood or other body fluids, 
mucous membranes, or nonintact skin of all patients; when handling items 
or surfaces soiled with blood or other body fluids; and when performing 
venipuncture and other vascular access procedures. Among other things, 
CDC's recommendation that health care providers wear medical gloves 
demonstrates the proposition that devices labeled as medical gloves 
purport to be and are represented to be effective barriers against the 
transmission of blood- and fluid-borne pathogens. Therefore, FDA, 
through this regulation, is defining adulteration for patient 
examination and surgeons' gloves as a means of assuring safe and 
effective devices.
    (1) For a description of a patient examination glove, see 
Sec. 880.6250. Finger cots, however, are excluded from the

[[Page 8]]

test method and sample plans in paragraphs (b) and (c) of this section.
    (2) For a description of a surgeons' glove, see Sec. 878.4460 of 
this chapter.
    (b) Test method. For the purposes of this regulation, FDA's analysis 
of gloves for leaks will be conducted by a water leak method, using 
1,000 milliliters (mL) of water. Each medical glove will be analyzed 
independently. When packaged as pairs, each glove is considered 
separately, and both gloves will be analyzed. A defect on one of the 
gloves is counted as one defect; a defect in both gloves is counted as 
two defects. Defects are defined as leaks, tears, mold, embedded foreigh 
objects, etc. A leak is defined as the appearance of water on the 
outside of the glove. This emergence of water from the glove constitutes 
a watertight barrier failure. Leaks within 1 and \1/2\ inches of the 
cuff are to be disregarded.
    (1) The following materials are required for testing: A 2\3/8\-inch 
by 15-inch (clear) plastic cylinder with a hook on one end and a mark 
scored 1\1/2\ inches from the other end (a cylinder of another size may 
be used if it accommodates both cuff diameter and any water above the 
glove capacity); elastic strapping with velcro or other fastening 
material; automatic water-dispensing apparatus or manual device capable 
of delivering 1,000 mL of water; a stand with horizontal rod for hanging 
the hook end of the plastic tube. The support rod must be capable of 
holding the weight of the total number of gloves that will be suspended 
at any one time, e.g., five gloves suspended will weigh about 11 pounds.
    (2) The following methodology is used: Examine the sample and 
identify code/ lot number, size, and brand as appropriate. Examine 
gloves for defects as follows: carefully remove the glove from the 
wrapper, box, etc., visually examining each glove for defects. Visual 
defects in the top 1\1/2\ inches of a glove will not be counted as a 
defect for the purposes of this rule. Visually defective gloves do not 
require further testing but are to be included in the total number of 
defective gloves counted for the sample. Attach the glove to the plastic 
fill tube by bringing the cuff end to the 1\1/2\-inch mark and fastening 
with elastic strapping to make a watertight seal. Add 1,000 mL of room 
temperature water (i.e., 20  deg.C to 30  deg.C) into the open end of 
the fill tube. The water shall pass freely into the glove. (With some 
larger sizes of long-cuffed surgeons' gloves, the water level may reach 
only the base of the thumb. With some smaller gloves, the water level 
may extend several inches up the fill tube.)
    (3) Immediately after adding the water, examine the glove for water 
leaks. Do not squeeze the glove; use only minimal manipulation to spread 
the fingers to check for leaks. Water drops may be blotted to confirm 
leaking. If the glove does not leak immediately, keep the glove/filling 
tube assembly upright and hang the assembly vertically from the 
horizontal rod, using the wire hook on the open end of the fill tube (do 
not support the filled glove while transferring). Make a second 
observation for leaks 2 minutes after addition of the water to the 
glove. Use only minimal manipulation of the fingers to check for leaks. 
Record the number of defective gloves.
    (c) Sample plans. FDA will collect samples from lots of gloves to 
perform the test for defects described in paragraph (b) of this section 
in accordance with FDA's sampling inspection plans which are based on 
the tables of MIL-STD-105E (the military sampling standard, ``Sampling 
Procedures and Tables for Inspection by Attributes,'' May 10, 1989). 
Based on the acceptable quality levels found in this standard, FDA has 
defined adulteration as follows: 2.5 or higher for surgeons' gloves and 
4.0 or higher for patient examination gloves at a general inspection 
level II. FDA will use single normal sampling for lots of 1,200 gloves 
or less and multiple normal sampling for all larger lots. For 
convenience, the sample plans (sample size and accept/reject numbers) 
are shown in the following tables:

[[Page 9]]



                                 Adulteration Level at 2.5 for Surgeons' Gloves
----------------------------------------------------------------------------------------------------------------
                                                                                              Number defective
                Lot size                            Sample              Sample     Number  ---------------------
                                                                         size     examined    Accept     Reject
----------------------------------------------------------------------------------------------------------------
35,001 and above........................  First.....................        125        125          2          9
                                          Second....................        125        250          7         14
                                          Third.....................        125        375         13         19
                                          Fourth....................        125        500         19         25
                                          Fifth.....................        125        625         25         29
                                          Sixth.....................        125        750         31         33
                                          Seventh...................        125        875         37         38
35,000 to 10,001........................  First.....................         80         80          1          7
                                          Second....................         80        160          4         10
                                          Third.....................         80        240          8         13
                                          Fourth....................         80        320         12         17
                                          Fifth.....................         80        400         17         20
                                          Sixth.....................         80        480         21         23
                                          Seventh...................         80        560         25         26
10,000 to 3,201.........................  First.....................         50         50          0          5
                                          Second....................         50        100          3          8
                                          Third.....................         50        150          6         10
                                          Fourth....................         50        200          8         13
                                          Fifth.....................         50        250         11         15
                                          Sixth.....................         50        300         14         17
                                          Seventh...................         50        350         18         19
3,200 to 1,201..........................  First.....................         32         32          0          4
                                          Second....................         32         64          1          6
                                          Third.....................         32         96          3          8
                                          Fourth....................         32        128          5         10
                                          Fifth.....................         32        160          7         11
                                          Sixth.....................         32        192         10         12
                                          Seventh...................         32        224         13         14
1,200 to 501............................  Single sample.............  .........         80          5          6
500 to 281..............................  Single sample.............  .........         50          3          4
280 to 151..............................  Single sample.............  .........         32          2          3
150 to 51...............................  Single sample.............  .........         20          1          2
50 to 0.................................  Single sample.............  .........          5          0          1
----------------------------------------------------------------------------------------------------------------


                            Adulteration Level at 4.0 for Patient Examination Gloves
----------------------------------------------------------------------------------------------------------------
                                                                                              Number defective
                Lot size                            Sample              Sample     Number  ---------------------
                                                                         size     examined    Accept     Reject
----------------------------------------------------------------------------------------------------------------
10,001 and above........................  First.....................         80         80          2          9
                                          Second....................         80        160          7         14
                                          Third.....................         80        240         13         19
                                          Fourth....................         80        320         19         25
                                          Fifth.....................         80        400         25         29
                                          Sixth.....................         80        480         31         33
                                          Seventh...................         80        560         37         38
10,000 to 3,201.........................  First.....................         50         50          1          7
                                          Second....................         50        100          4         10
                                          Third.....................         50        150          8         13
                                          Fourth....................         50        200         12         17
                                          Fifth.....................         50        250         17         20
                                          Sixth.....................         50        300         21         23
                                          Seventh...................         50        350         25         26
3,200 to 1,201..........................  First.....................         32         32          0          5
                                          Second....................         32         64          3          8
                                          Third.....................         32         96          6         10
                                          Fourth....................         32        128          8         13
                                          Fifth.....................         32        160         11         15
                                          Sixth.....................         32        192         14         17
                                          Seventh...................         32        224         18         19
1,200 to 501............................  Single sample.............  .........         80          7          8
500 to 281..............................  Single sample.............  .........         50          5          6
280 to 151..............................  Single sample.............  .........         32          3          4
150 to 91...............................  Single sample.............  .........         20          2          3
90 to 26................................  Single sample.............  .........         13          1          2
25 to 0.................................  Single sample.............  .........          3          0          1
----------------------------------------------------------------------------------------------------------------


[[Page 10]]

    (d) Lots of gloves which are tested and rejected using the test 
method according to paragraph (b) of this section, are adulterated 
within the meaning of section 501(c) of the Federal Food, Drug, and 
Cosmetic Act, and are subject to regulatory action, such as detention of 
imported products and seizure of domestic products.

[55 FR 51256, Dec. 12, 1990]



           Subpart C--Administrative Practices and Procedures



Sec. 800.55  Administrative detention.

    (a) General. This section sets forth the procedures for detention of 
medical devices intended for human use believed to be adulterated or 
misbranded. Administrative detention is intended to protect the public 
by preventing distribution or use of devices encountered during 
inspections that may be adulterated or misbranded, until the Food and 
Drug Administration (FDA) has had time to consider what action it should 
take concerning the devices, and to initiate legal action, if 
appropriate. Devices that FDA orders detained may not be used, moved, 
altered, or tampered with in any manner by any person during the 
detention period, except as authorized under paragraph (h) of this 
section, until FDA terminates the detention order under paragraph (j) of 
this section, or the detention period expires, whichever occurs first.
    (b) Criteria for ordering detention. Administrative detention of 
devices may be ordered in accordance with this section when an 
authorized FDA representative, during an inspection under section 704 of 
the Federal Food, Drug, and Cosmetic Act (the act), has reason to 
believe that a device, as defined in section 201(h) of the act, is 
adulterated or misbranded.
    (c) Detention period. The detention is to be for a reasonable period 
that may not exceed 20 calendar days after the detention order is 
issued, unless the FDA District Director in whose district the devices 
are located determines that a greater period is required to seize the 
devices, to institute injuction proceedings, or to evaluate the need for 
legal action, in which case the District Director may authorize 
detention for 10 additional calendar days. The additional 10-calendar-
day detention period may be ordered at the time the detention order is 
issued or at any time thereafter. The entire detention period may not 
exceed 30 calendar days, except when the detention period is extended 
under paragraph (g)(6) of this section. An authorized FDA representative 
may, in accordance with paragraph (j) of this section, terminate a 
detention before the expiration of the detention period.
    (d) Issuance of detention order. (1) The detention order shall be 
issued in writing, in the form of a detention notice, signed by the 
authorized FDA representative who has reason to believe that the devices 
are adulterated or misbranded, and issued to the owner, operator, or 
agent in charge of the place where the devices are located. If the owner 
or the user of the devices is different from the owner, operator, or 
agent in charge of the place where the devices are detained, a copy of 
the detention order shall be provided to the owner or user of the 
devices if the owner's or user's identity can be readily determined.
    (2) If detention of devices in a vehicle or other carrier is 
ordered, a copy of the detention order shall be provided to the shipper 
of record and the owner of the vehicle or other carrier, if their 
identities can be readily determined.
    (3) The detention order shall include the following information: (i) 
A statement that the devices identified in the order are detained for 
the period shown; (ii) a brief, general statement of the reasons for the 
detention; (iii) the location of the devices; (iv) a statement that 
these devices are not to be used, moved, altered, or tampered with in 
any manner during that period, except as permitted under paragraph (h) 
of this section, without the written permission of an authorized FDA 
representative; (v) identification of the detained devices; (vi) the 
detention order number; (vii) the date and hour of the detention order; 
(viii) the period of the detention; (ix) the text of section 304(g) of 
the act and paragraph (g) (1) and (2) of this section; (x) a statement 
that any informal hearing on an appeal of a detention order shall be 
conducted as a

[[Page 11]]

regulatory hearing under part 16 of this chapter, with certain 
exceptions described in paragraph (g)(3) of this section; and (xi) the 
location and telephone number of the FDA district office and the name of 
the FDA District Director.
    (e) Approval of detention order. A detention order, before issuance, 
shall be approved by the FDA District Director in whose district the 
devices are located. If prior written approval is not feasible, prior 
oral approval shall be obtained and confirmed by written memorandum 
within FDA as soon as possible.
    (f) Labeling or marking a detained device. An FDA representative 
issuing a detention order under paragraph (d) of this section shall 
label or mark the devices with official FDA tags that include the 
following information:
    (1) A statement that the devices are detained by the United States 
Government in accordance with section 304(g) of the Federal Food, Drug, 
and Cosmetic Act (21 U.S.C. 334(g)).
    (2) A statement that the devices shall not be used, moved, altered, 
or tampered with in any manner for the period shown, without the written 
permission of an authorized FDA representative, except as authorized in 
paragraph (h) of this section.
    (3) A statement that the violation of a detention order or the 
removal or alteration of the tag is punishable by fine or imprisonment 
or both (section 303 of the act, 21 U.S.C. 333).
    (4) The detention order number, the date and hour of the detention 
order, the detention period, and the name of the FDA representative who 
issued the detention order.
    (g) Appeal of a detention order. (1) A person who would be entitled 
to claim the devices, if seized, may appeal a detention order. Any 
appeal shall be submitted in writing to the FDA District Director in 
whose district the devices are located within 5 working days of receipt 
of a detention order. If the appeal includes a request for an informal 
hearing, as defined in section 201(y) of the act, the appellant shall 
request either that a hearing be held within 5 working days after the 
appeal is filed or that the hearing be held at a later date, which shall 
not be later than 20 calendar days after receipt of a detention order.
    (2) The appellant of a detention order shall state the ownership or 
proprietary interest the appellant has in the detained devices. If the 
detained devices are located at a place other than an establishment 
owned or operated by the appellant, the appellant shall include 
documents showing that the appellant would have legitimate authority to 
claim the devices if seized.
    (3) Any informal hearing on an appeal of a detention order shall be 
conducted as a regulatory hearing pursuant to regulation in accordance 
with part 16 of this chapter, except that:
    (i) The detention order under paragraph (d) of this section, rather 
than the notice under Sec. 16.22(a) of this chapter, provides notice of 
opportunity for a hearing under this section and is part of the 
administrative record of the regulatory hearing under Sec. 16.80(a) of 
this chapter.
    (ii) A request for a hearing under this section should be addressed 
to the FDA District Director.
    (iii) The last sentence of Sec. 16.24(e) of this chapter, stating 
that a hearing may not be required to be held at a time less than 2 
working days after receipt of the request for a hearing, does not apply 
to a hearing under this section.
    (iv) Paragraph (g)(4) of this section, rather than Sec. 16.42(a) of 
this chapter, describes the FDA employees, i.e., regional food and drug 
directors, who preside at hearings under this section.
    (4) The presiding officer of a regulatory hearing on an appeal of a 
detention order, who also shall decide the appeal, shall be a regional 
food and drug director (i.e., a director of an FDA regional office 
listed in Sec. 5.115 of this chapter) who is permitted by Sec. 16.42(a) 
of this chapter to preside over the hearing.
    (5) If the appellant requests a regulatory hearing and requests that 
the hearing be held within 5 working days after the appeal is filed, the 
presiding officer shall, within 5 working days, hold the hearing and 
render a decision affirming or revoking the detention.
    (6) If the appellant requests a regulatory hearing and requests that 
the hearing be held at a date later than

[[Page 12]]

within 5 working days after the appeal is filed, but not later than 20 
calendar days after receipt of a detention order, the presiding officer 
shall hold the hearing at a date agreed upon by FDA and the appellant. 
The presiding officer shall decide whether to affirm or revoke the 
detention within 5 working days after the conclusion of the hearing. The 
detention period extends to the date of the decision even if the 5-
working-day period for making the decision extends beyond the otherwise 
applicable 20-calendar-day or 30-calendar-day detention period.
    (7) If the appellant appeals the detention order but does not 
request a regulatory hearing, the presiding officer shall render a 
decision on the appeal affirming or revoking the detention within 5 
working days after the filing of the appeal.
    (8) If the presiding officer affirms a detention order, the devices 
continue to be detained until FDA terminates the detention under 
paragraph (j) of this section or the detention period expires, whichever 
occurs first.
    (9) If the presiding officer revokes a detention order, FDA shall 
terminate the detention under paragraph (j) of this section.
    (h)(1) Movement of detained devices. Except as provided in this 
paragraph, no person shall move detained devices within or from the 
place where they have been ordered detained until FDA terminates the 
detention under paragraph (j) of this section or the detention period 
expires, whichever occurs first.
    (2) If detained devices are not in final form for shipment, the 
manufacturer may move them within the establishment where they are 
detained to complete the work needed to put them in final form. As soon 
as the devices are moved for this purpose, the individual responsible 
for their movement shall orally notify the FDA representative who issued 
the detention order, or another responsible district office official, of 
the movement of the devices. As soon as the devices are put in final 
form, they shall be segregated from other devices, and the individual 
responsible for their movement shall orally notify the FDA 
representative who issued the detention order, or another responsible 
district office official, of their new location. The devices put in 
final form shall not be moved further without FDA approval.
    (3) The FDA representative who issued the detention order, or 
another responsible district office official, may approve, in writing, 
the movement of detained devices for any of the following purposes:
    (i) To prevent interference with an establishment's operations or 
harm to the devices.
    (ii) To destroy the devices.
    (iii) To bring the devices into compliance.
    (iv) For any other purpose that the FDA representative who issued 
the detention order, or other responsible district office official, 
believes is appropriate in the case.
    (4) If an FDA representative approves the movement of detained 
devices under paragraph (h)(3) of this section, the detained devices 
shall remain segregated from other devices and the person responsible 
for their movement shall immediately orally notify the official who 
approved the movement of the devices, or another responsible FDA 
district office official, of the new location of the detained devices.
    (5) Unless otherwise permitted by the FDA representative who is 
notified of, or who approves, the movement of devices under this 
paragraph, the required tags shall accompany the devices during and 
after movement and shall remain with the devices until FDA terminates 
the detention or the detention period expires, whichever occurs first.
    (i) Actions involving adulterated or misbranded devices. If FDA 
determines that the detained devices, including any that have been put 
in final form, are adulterated or misbranded, or both, it may initiate 
legal action against the devices or the responsible individuals, or 
both, or request that the devices be destroyed or otherwise brought into 
compliance with the act under FDA's supervision.
    (j) Detention termination. If FDA decides to terminate a detention 
or when the detention period expires, whichever occurs first, an FDA 
representative authorized to terminate a detention will issue a 
detention termination notice

[[Page 13]]

releasing the devices to any person who received the original detention 
order or that person's representative and will remove, or authorize in 
writing the removal of, the required labels or tags.
    (k) Recordkeeping requirements. (1) After issuance of a detention 
order under paragraph (d) of this section, the owner, operator, or agent 
is charge of any factory, warehouse, other establishment, or consulting 
laboratory where detained devices are manufactured, processed, packed, 
or held shall have, or establish, and maintain adequate records relating 
to how the detained devices may have become adulterated or misbranded, 
records on any distribution of the devices before and after the 
detention period, records on the correlation of any in-process detained 
devices that are put in final form under paragraph (h) of this section 
to the completed devices, records of any changes in, or processing of, 
the devices permitted under the detention order, and records of any 
other movement under paragraph (h) of this section. Records required 
under this paragraph shall be provided to the FDA on request for review 
and copying. Any FDA request for access to records required under this 
paragraph shall be made at a reasonable time, shall state the reason or 
purpose for the request, and shall identify to the fullest extent 
practicable the information or type of information sought in the records 
to which access is requested.
    (2) Records required under this paragraph shall be maintained for a 
maximum period of 2 years after the issuance of the detention order or 
for such other shorter period as FDA directs. When FDA terminates the 
detention or when the detention period expires, whichever occurs first, 
FDA will advise all persons required under this paragraph to keep 
records concerning that detention whether further recordkeeping is 
required for the remainder of the 2-year, or shorter, period. FDA 
ordinarily will not require further recordkeeping if the agency 
determines that the devices are not adulterated or misbranded or that 
recordkeeping is not necessary to protect the public health, unless the 
records are required under other regulations in this chapter (e.g., the 
good manufacturing practice regulation in part 820 of this chapter).

[44 FR 13239, Mar. 9, 1979, as amended at 49 FR 3174, Jan. 26, 1984]



PART 801--LABELING--Table of Contents




                 Subpart A--General Labeling Provisions

Sec.
801.1  Medical devices; name and place of business of manufacturer, 
          packer or distributor.
801.4  Meaning of intended uses.
801.5  Medical devices; adequate directions for use.
801.6  Medical devices; misleading statements.
801.15  Medical devices; prominence of required label statements.
801.16  Medical devices; Spanish-language version of certain required 
          statements.

Subpart B  [Reserved]

      Subpart C--Labeling Requirements for Over-the-Counter Devices

801.60  Principal display panel.
801.61  Statement of identity.
801.62  Declaration of net quantity of contents.
801.63  Medical devices; warning statements for devices containing or 
          manufactured with chlorofluorocarbons and other class I ozone-
          depleting substances.

         Subpart D--Exemptions From Adequate Directions for Use

801.109  Prescription devices.
801.110  Retail exemption for prescription devices.
801.116  Medical devices having commonly known directions.
801.119  In vitro diagnostic products.
801.122  Medical devices for processing, repacking, or manufacturing.
801.125  Medical devices for use in teaching, law enforcement, research, 
          and analysis.
801.127  Medical devices; expiration of exemptions.

                       Subpart E--Other Exemptions

801.150  Medical devices; processing, labeling, or repacking.

Subparts F-G  [Reserved]

          Subpart H--Special Requirements for Specific Devices

801.405  Labeling of articles intended for lay use in the repairing and/
          or refitting of dentures.

[[Page 14]]

801.410  Use of impact-resistant lenses in eyeglasses and sunglasses.
801.415  Maximum acceptable level of ozone.
800.417  Chlorofluorocarbon propellants.
801.420  Hearing aid devices; professional and patient labeling.
801.421  Hearing aid devices; conditions for sale.
801.430  User labeling for menstrual tampons.
801.433  Warning statements for prescription and restricted device 
          products containing or manufactured with chlorofluorocarbons 
          or other ozone-depleting substances.
801.435  User labeling for latex condoms.
801.437  User labeling for devices that contain natural rubber.

    Authority: 21 U.S.C. 321, 331, 351, 352, 360i, 360j, 371, 374.

    Source: 41 FR 6896, Feb. 13, 1976, unless otherwise noted.



                 Subpart A--General Labeling Provisions



Sec. 801.1  Medical devices; name and place of business of manufacturer, packer or distributor.

    (a) The label of a device in package form shall specify 
conspicuously the name and place of business of the manufacturer, 
packer, or distributor.
    (b) The requirement for declaration of the name of the manufacturer, 
packer, or distributor shall be deemed to be satisfied, in the case of a 
corporation, only by the actual corporate name which may be preceded or 
followed by the name of the particular division of the corporation. 
Abbreviations for ``Company,'' ``Incorporated,'' etc., may be used and 
``The'' may be omitted. In the case of an individual, partnership, or 
association, the name under which the business is conducted shall be 
used.
    (c) Where a device is not manufactured by the person whose name 
appears on the label, the name shall be qualified by a phrase that 
reveals the connection such person has with such device; such as, 
``Manufactured for ______'', ``Distributed by __________'', or any other 
wording that expresses the facts.
    (d) The statement of the place of business shall include the street 
address, city, State, and Zip Code; however, the street address may be 
omitted if it is shown in a current city directory or telephone 
directory. The requirement for inclusion of the ZIP Code shall apply 
only to consumer commodity labels developed or revised after the 
effective date of this section. In the case of nonconsumer packages, the 
ZIP Code shall appear on either the label or the labeling (including the 
invoice).
    (e) If a person manufactures, packs, or distributes a device at a 
place other than his principal place of business, the label may state 
the principal place of business in lieu of the actual place where such 
device was manufactured or packed or is to be distributed, unless such 
statement would be misleading.



Sec. 801.4  Meaning of ``intended uses.''

    The words intended uses or words of similar import in Secs. 801.5, 
801.119, and 801.122 refer to the objective intent of the persons 
legally responsible for the labeling of devices. The intent is 
determined by such persons' expressions or may be shown by the 
circumstances surrounding the distribution of the article. This 
objective intent may, for example, be shown by labeling claims, 
advertising matter, or oral or written statements by such persons or 
their representatives. It may be shown by the circumstances that the 
article is, with the knowledge of such persons or their representatives, 
offered and used for a purpose for which it is neither labeled nor 
advertised. The intended uses of an article may change after it has been 
introduced into interstate commerce by its manufacturer. If, for 
example, a packer, distributor, or seller intends an article for 
different uses than those intended by the person from whom he received 
the devices, such packer, distributor, or seller is required to supply 
adequate labeling in accordance with the new intended uses. But if a 
manufacturer knows, or has knowledge of facts that would give him notice 
that a device introduced into interstate commerce by him is to be used 
for conditions, purposes, or uses other than the ones for which he 
offers it, he is required to provide adequate labeling for such a device 
which accords with such other uses to which the article is to be put.

[[Page 15]]



Sec. 801.5  Medical devices; adequate directions for use.

    Adequate directions for use means directions under which the layman 
can use a device safely and for the purposes for which it is intended. 
Section 801.4 defines intended use. Directions for use may be inadequate 
because, among other reasons, of omission, in whole or in part, or 
incorrect specification of:
    (a) Statements of all conditions, purposes, or uses for which such 
device is intended, including conditions, purposes, or uses for which it 
is prescribed, recommended, or suggested in its oral, written, printed, 
or graphic advertising, and conditions, purposes, or uses for which the 
device is commonly used; except that such statements shall not refer to 
conditions, uses, or purposes for which the device can be safely used 
only under the supervision of a practitioner licensed by law and for 
which it is advertised solely to such practitioner.
    (b) Quantity of dose, including usual quantities for each of the 
uses for which it is intended and usual quantities for persons of 
different ages and different physical conditions.
    (c) Frequency of administration or application.
    (d) Duration of administration or application.
    (e) Time of administration or application, in relation to time of 
meals, time of onset of symptoms, or other time factors.
    (f) Route or method of administration or application.
    (g) Preparation for use, i.e., adjustment of temperature, or other 
manipulation or process.



Sec. 801.6  Medical devices; misleading statements.

    Among representations in the labeling of a device which render such 
device misbranded is a false or misleading representation with respect 
to another device or a drug or food or cosmetic.



Sec. 801.15  Medical devices; prominence of required label statements.

    (a) A word, statement, or other information required by or under 
authority of the act to appear on the label may lack that prominence and 
conspicuousness required by section 502(c) of the act by reason, among 
other reasons, of:
    (1) The failure of such word, statement, or information to appear on 
the part or panel of the label which is presented or displayed under 
customary conditions of purchase;
    (2) The failure of such word, statement, or information to appear on 
two or more parts or panels of the label, each of which has sufficient 
space therefor, and each of which is so designed as to render it likely 
to be, under customary conditions of purchase, the part or panel 
displayed;
    (3) The failure of the label to extend over the area of the 
container or package available for such extension, so as to provide 
sufficient label space for the prominent placing of such word, 
statement, or information;
    (4) Insufficiency of label space for the prominent placing of such 
word, statement, or information, resulting from the use of label space 
for any word, statement, design, or device which is not required by or 
under authority of the act to appear on the label;
    (5) Insufficiency of label space for the placing of such word, 
statement, or information, resulting from the use of label space to give 
materially greater conspicuousness to any other word, statement, or 
information, or to any design or device; or
    (6) Smallness or style of type in which such word, statement, or 
information appears, insufficient background contrast, obscuring designs 
or vignettes, or crowding with other written, printed, or graphic 
matter.
    (b) No exemption depending on insufficiency of label space, as 
prescribed in regulations promulgated under section 502(b) of the act, 
shall apply if such insufficiency is caused by:
    (1) The use of label space for any word, statement, design, or 
device which is not required by or under authority of the act to appear 
on the label;
    (2) The use of label space to give greater conspicuousness to any 
word, statement, or other information than is required by section 502(c) 
of the act; or
    (3) The use of label space for any representation in a foreign 
language.

[[Page 16]]

    (c)(1) All words, statements, and other information required by or 
under authority of the act to appear on the label or labeling shall 
appear thereon in the English language: Provided, however, That in the 
case of articles distributed solely in the Commonwealth of Puerto Rico 
or in a Territory where the predominant language is one other than 
English, the predominant language may be substituted for English.
    (2) If the label contains any representation in a foreign language, 
all words, statements, and other information required by or under 
authority of the act to appear on the label shall appear thereon in the 
foreign language.
    (3) If the labeling contains any representation in a foreign 
language, all words, statements, and other information required by or 
under authority of the act to appear on the label or labeling shall 
appear on the labeling in the foreign language.



Sec. 801.16  Medical devices; Spanish-language version of certain required statements.

    If devices restricted to prescription use only are labeled solely in 
Spanish for distribution in the Commonwealth of Puerto Rico where 
Spanish is the predominant language, such labeling is authorized under 
Sec. 801.15(c).

Subpart B  [Reserved]



      Subpart C--Labeling Requirements for Over-the-Counter Devices



Sec. 801.60  Principal display panel.

    The term principal display panel, as it applies to over-the-counter 
devices in package form and as used in this part, means the part of a 
label that is most likely to be displayed, presented, shown, or examined 
under customary conditions of display for retail sale. The principal 
display panel shall be large enough to accommodate all the mandatory 
label information required to be placed thereon by this part with 
clarity and conspicuousness and without obscuring designs, vignettes, or 
crowding. Where packages bear alternate principal display panels, 
information required to be placed on the principal display panel shall 
be duplicated on each principal display panel. For the purpose of 
obtaining uniform type size in declaring the quantity of contents for 
all packages of substantially the same size, the term area of the 
principal display panel means the area of the side or surface that bears 
the principal display panel, which area shall be:
    (a) In the case of a rectangular package where one entire side 
properly can be considered to be the principal display panel side, the 
product of the height times the width of that side;
    (b) In the case of a cylindrical or nearly cylindrical container, 40 
percent of the product of the height of the container times the 
circumference; and
    (c) In the case of any other shape of container, 40 percent of the 
total surface of the container: Provided, however, That where such 
container presents an obvious ``principal display panel'' such as the 
top of a triangular or circular package, the area shall consist of the 
entire top surface.

In determining the area of the principal display panel, exclude tops, 
bottoms, flanges at the tops and bottoms of cans, and shoulders and 
necks of bottles or jars. In the case of cylindrical or nearly 
cylindrical containers, information required by this part to appear on 
the principal display panel shall appear within that 40 percent of the 
circumference which is most likely to be displayed, presented, shown, or 
examined under customary conditions of display for retail sale.



Sec. 801.61  Statement of identity.

    (a) The principal display panel of an over-the-counter device in 
package form shall bear as one of its principal features a statement of 
the identity of the commodity.
    (b) Such statement of identity shall be in terms of the common name 
of the device followed by an accurate statement of the principal 
intended action(s) of the device. Such statement shall be placed in 
direct conjunction with the most prominent display of the name and shall 
employ terms descriptive of the principal intended action(s). The 
indications for use shall be included in the directions for use of the 
device, as required by section 502(f)(1)

[[Page 17]]

of the act and by the regulations in this part.
    (c) The statement of identity shall be presented in bold face type 
on the principal display panel, shall be in a size reasonably related to 
the most prominent printed matter on such panel, and shall be in lines 
generally parallel to the base on which the package rests as it is 
designed to be displayed.



Sec. 801.62  Declaration of net quantity of contents.

    (a) The label of an over-the-counter device in package form shall 
bear a declaration of the net quantity of contents. This shall be 
expressed in the terms of weight, measure, numerical count, or a 
combination of numerical count and weight, measure, or size: Provided, 
That:
    (1) In the case of a firmly established general consumer usage and 
trade custom of declaring the quantity of a device in terms of linear 
measure or measure of area, such respective term may be used. Such term 
shall be augmented when necessary for accuracy of information by a 
statement of the weight, measure, or size of the individual units or of 
the entire device.
    (2) If the declaration of contents for a device by numerical count 
does not give accurate information as to the quantity of the device in 
the package, it shall be augmented by such statement of weight, measure, 
or size of the individual units or of the total weight, measure, or size 
of the device as will give such information; for example, ``100 tongue 
depressors, adult size'', ``1 rectal syringe, adult size'', etc. 
Whenever the Commissioner determines for a specific packaged device that 
an existing practice of declaring net quantity of contents by weight, 
measure, numerical count, or a combination of these does not facilitate 
value comparisions by consumers, he shall by regulation designate the 
appropriate term or terms to be used for such article.
    (b) Statements of weight of the contents shall be expressed in terms 
of avoirdupois pound and ounce. A statement of liquid measure of the 
contents shall be expressed in terms of the U.S. gallon of 231 cubic 
inches and quart, pint, and fluid-ounce subdivisions thereof, and shall 
express the volume at 68  deg.F (20  deg.C). See also paragraph (p) of 
this section.
    (c) The declaration may contain common or decimal fractions. A 
common fraction shall be in terms of halves, quarters, eighths, 
sixteenths, or thirty-seconds; except that if there exists a firmly 
established, general consumer usage and trade custom of employing 
different common fractions in the net quantity declaration of a 
particular commodity, they may be employed. A common fraction shall be 
reduced to its lowest terms; a decimal fraction shall not be carried out 
to more than two places. A statement that includes small fractions of an 
ounce shall be deemed to permit smaller variations than one which does 
not include such fractions.
    (d) The declaration shall be located on the principal display panel 
of the label, and with respect to packages bearing alternate principal 
panels it shall be duplicated on each principal display panel.
    (e) The declaration shall appear as a distinct item on the principal 
display panel, shall be separated, by at least a space equal to the 
height of the lettering used in the declaration, from other printed 
label information appearing above or below the declaration and, by at 
least a space equal to twice the width of the letter ``N'' of the style 
of type used in the quantity of contents statement, from other printed 
label information appearing to the left or right of the declaration. It 
shall not include any term qualifying a unit of weight, measure, or 
count, such as ``giant pint'' and ``full quart'', that tends to 
exaggerate. It shall be placed on the principal display panel within the 
bottom 30 percent of the area of the label panel in lines generally 
parallel to the base on which the package rests as it is designed to be 
displayed: Provided, That:
    (1) On packages having a principal display panel of 5 square inches 
or less the requirement for placement within the bottom 30 percent of 
the area of the label panel shall not apply when the declaration of net 
quantity of contents meets the other requirements of this part; and
    (2) In the case of a device that is marketed with both outer and 
inner retail

[[Page 18]]

containers bearing the mandatory label information required by this part 
and the inner container is not intended to be sold separately, the net 
quantity of contents placement requirement of this section applicable to 
such inner container is waived.
    (3) The principal display panel of a device marketed on a display 
card to which the immediate container is affixed may be considered to be 
the display panel of the card, and the type size of the net quantity of 
contents statement is governed by the dimensions of the display card.
    (f) The declaration shall accurately reveal the quantity of device 
in the package exclusive of wrappers and other material packed 
therewith.
    (g) The declaration shall appear in conspicuous and easily legible 
boldface print or type in distinct contrast (by typography, layout, 
color, embossing, or molding) to other matter on the package; except 
that a declaration of net quantity blown, embossed, or molded on a glass 
or plastic surface is permissible when all label information is so 
formed on the surface. Requirements of conspicuousness and legibility 
shall include the specifications that:
    (1) The ratio of height to width of the letter shall not exceed a 
differential of 3 units to 1 unit, i.e., no more than 3 times as high as 
it is wide.
    (2) Letter heights pertain to upper case or capital letters. When 
upper and lower case or all lower case letters are used, it is the lower 
case letter ``o'' or its equivalent that shall meet the minimum 
standards.
    (3) When fractions are used, each component numeral shall meet one-
half the minimum height standards.
    (h) The declaration shall be in letters and numerals in a type size 
established in relationship to the area of the principal display panel 
of the package and shall be uniform for all packages of substantially 
the same size by complying with the following type specifications:
    (1) Not less than one-sixteenth inch in height on packages the 
principal display panel of which has an area of 5 square inches or less.
    (2) Not less than one-eighth inch in height on packages the 
principal display panel of which has an area of more than 5 but not more 
than 25 square inches.
    (3) Not less than three-sixteenths inch in height on packages the 
principal display panel of which has an area of more than 25 but not 
more than 100 square inches.
    (4) Not less than one-fourth inch in height on packages the 
principal display panel of which has an area of more than 100 square 
inches, except not less than one-half inch in height if the area is more 
than 400 square inches.

Where the declaration is blown, embossed, or molded on a glass or 
plastic surface rather than by printing, typing, or coloring, the 
lettering sizes specified in paragraphs (h)(1) through (4) of this 
section shall be increased by one-sixteenth of an inch.
    (i) On packages containing less than 4 pounds or 1 gallon and 
labeled in terms of weight or fluid measure:
    (1) The declaration shall be expressed both in ounces, with 
identification by weight or by liquid measure and, if applicable (1 
pound or 1 pint or more) followed in parentheses by a declaration in 
pounds for weight units, with any remainder in terms of ounces or common 
or decimal fractions of the pound (see examples set forth in paragraphs 
(k) (1) and (2) of this section), or in the case of liquid measure, in 
the largest whole units (quarts, quarts and pints, or pints, as 
appropriate) with any remainder in terms of fluid ounces or common or 
decimal fractions of the pint or quart (see examples set forth in 
paragraphs (k) (3) and (4) of this section). If the net weight of the 
package is less than 1 ounce avoirdupois or the net fluid measure is 
less than 1 fluid ounce, the declaration shall be in terms of common or 
decimal fractions of the respective ounce and not in terms of drams.
    (2) The declaration may appear in more than one line. The term ``net 
weight'' shall be used when stating the net quantity of contents in 
terms of weight. Use of the terms ``net'' or ``net contents'' in terms 
of fluid measure or numerical count is optional. It is sufficient to 
distinguish avoirdupois ounce from fluid ounce through association of 
terms; for example, ``Net wt. 6 oz'' or ``6 oz net wt.,'' and ``6 fl 
oz'' or ``net contents 6 fl oz.''

[[Page 19]]

    (j) On packages containing 4 pounds or 1 gallon or more and labeled 
in terms of weight or fluid measure, the declaration shall be expressed 
in pounds for weight units with any remainder in terms of ounces or 
common or decimal fractions of the pound; in the case of fluid measure, 
it shall be expressed in the largest whole unit, i.e., gallons, followed 
by common or decimal fractions of a gallon or by the next smaller whole 
unit or units (quarts or quarts and pints), with any remainder in terms 
of fluid ounces or common or decimal fractions of the pint or quart; see 
paragraph (k)(5) of this section.
    (k) Examples: (1) A declaration of 1\1/2\ pounds weight shall be 
expressed as ``net wt. 24 oz (1 lb 8 oz),'' or ``Net wt. 24 oz (1\1/2\ 
lb)'' or ``Net wt. 24 oz (1.5 lb).''
    (2) A declaration of three-fourths pound avoirdupois weight shall be 
expressed as ``Net wt. 12 oz.''.
    (3) A declaration of 1 quart liquid measure shall be expressed as 
``Net contents 32 fl oz (1 qt)'' or ``32 fl oz (1 qt).''
    (4) A declaration of 1\3/4\ quarts liquid measure shall be expressed 
as, ``Net contents 56 fl oz (1 qt 1 pt 8 oz)'' or ``Net contents 56 fl 
oz (1 qt 1.5 pt),'' but not in terms of quart and ounce such as ``Net 
contents 56 fl oz (1 qt 24 oz).''
    (5) A declaration of 2\1/2\ gallons liquid measure shall be 
expressed as ``Net contents 2 gal 2 qt'', ``Net contents 2.5 gallons,'' 
or ``Net contents 2\1/2\ gal'' but not as ``2 gal 4 pt''.
    (l) For quantities, the following abbreviations and none other may 
be employed. Periods and plural forms are optional:

gallon gal                            liter l
milliliter ml                         cubic centimeter cc
quart qt                              yard yd
pint pt                               feet or foot ft
ounce oz                              inch in
pound lb                              meter m
grain gr                              centimeter cm
kilogram kg                           millimeter mm
gram g                                fluid fl
milligram mg                          square sq
microgram mcg                         weight wt
 

    (m) On packages labeled in terms of linear measure, the declaration 
shall be expressed both in terms of inches and, if applicable (1 foot or 
more), the largest whole units (yards, yards and feet, feet). The 
declaration in terms of the largest whole units shall be in parentheses 
following the declaration in terms of inches and any remainder shall be 
in terms of inches or common or decimal fractions of the foot or yard; 
if applicable, as in the case of adhesive tape, the initial declaration 
in linear inches shall be preceded by a statement of the width. Examples 
of linear measure are ``86 inches (2 yd 1 ft 2 in)'', ``90 inches (2\1/
2\ yd)'', ``30 inches (2.5 ft)'', ``\3/4\ inch by 36 in (1 yd)'', etc.
    (n) On packages labeled in terms of area measure, the declaration 
shall be expressed both in terms of square inches and, if applicable (1 
square foot or more), the largest whole square unit (square yards, 
square yards and square feet, square feet). The declaration in terms of 
the largest whole units shall be in parentheses following the 
declaration in terms of square inches and any remainder shall be in 
terms of square inches or common or decimal fractions of the square foot 
or square yard; for example, ``158 sq inches (1 sq ft 14 sq in)''.
    (o) Nothing in this section shall prohibit supplemental statements 
at locations other than the principal display panel(s) describing in 
nondeceptive terms the net quantity of contents, provided that such 
supplemental statements of net quantity of contents shall not include 
any term qualifying a unit of weight, measure, or count that tends to 
exaggerate the amount of the device contained in the package; for 
example, ``giant pint'' and ``full quart''. Dual or combination 
declarations of net quantity of contents as provided for in paragraphs 
(a) and (i) of this section are not regarded as supplemental net 
quantity statements and shall be located on the principal display panel.
    (p) A separate statement of net quantity of contents in terms of the 
metric system of weight or measure is not regarded as a supplemental 
statement and an accurate statement of the net quantity of contents in 
terms of the metric system of weight or measure may also appear on the 
principal display panel or on other panels.
    (q) The declaration of net quantity of contents shall express an 
accurate statement of the quantity of contents of the package. 
Reasonable variations caused by loss or gain of moisture during the 
course of good distribution

[[Page 20]]

practice or by unavoidable deviations in good manufacturing practice 
will be recognized. Variations from stated quantity of contents shall 
not be unreasonably large.



Sec. 801.63  Medical devices; warning statements for devices containing or manufactured with chlorofluorocarbons and other class I ozone-depleting substances.

    (a) All over-the-counter devices containing or manufactured with 
chlorofluorocarbons, halons, carbon tetrachloride, methyl chloride, or 
any other class I substance designated by the Environmental Protection 
Agency (EPA) shall carry one of the following warnings:
    (1) The EPA warning statement:

    Warning: Contains [or Manufactured with, if applicable] [insert name 
of substance], a substance which harms public health and environment by 
destroying ozone in the upper atmosphere.

    (2) The alternative statement:
    Note: The indented statement below is required by the Federal 
government's Clean Air Act for all products containing or manufactured 
with chlorofluorocarbons (CFC's) [or other class I substance, if 
applicable]:

    Warning: Contains [or Manufactured with, if applicable] [insert name 
of substance], a substance which harms public health and environment by 
destroying ozone in the upper atmosphere.

    CONSULT WITH YOUR PHYSICIAN, HEALTH PROFESSIONAL, OR SUPPLIER IF YOU 
HAVE ANY QUESTION ABOUT THE USE OF THIS PRODUCT.
    (b) The warning statement shall be clearly legible and conspicuous 
on the product, its immediate container, its outer packaging, or other 
labeling in accordance with the requirements of 40 CFR part 82 and 
appear with such prominence and conspicuousness as to render it likely 
to be read and understood by consumers under normal conditions of 
purchase. This provision does not replace or relieve a person from any 
requirements imposed under 40 CFR part 82.

[61 FR 20101, May 3, 1996]



         Subpart D--Exemptions From Adequate Directions for Use



Sec. 801.109  Prescription devices.

    A device which, because of any potentiality for harmful effect, or 
the method of its use, or the collateral measures necessary to its use 
is not safe except under the supervision of a practitioner licensed by 
law to direct the use of such device, and hence for which ``adequate 
directions for use'' cannot be prepared, shall be exempt from section 
502(f)(1) of the act if all the following conditions are met:
    (a) The device is:
    (1)(i) In the possession of a person, or his agents or employees, 
regularly and lawfully engaged in the manufacture, transportation, 
storage, or wholesale or retail distribution of such device; or
    (ii) In the possession of a practitioner, such as physicians, 
dentists, and veterinarians, licensed by law to use or order the use of 
such device; and
    (2) Is to be sold only to or on the prescription or other order of 
such practitioner for use in the course of his professional practice.
    (b) The label of the device, other than surgical instruments, bears:
    (1) The statement ``Caution: Federal law restricts this device to 
sale by or on the order of a ________'', the blank to be filled with the 
word ``physician'', ``dentist'', ``veterinarian'', or with the 
descriptive designation of any other practitioner licensed by the law of 
the State in which he practices to use or order the use of the device; 
and
    (2) The method of its application or use.
    (c) Labeling on or within the package from which the device is to be 
dispensed bears information for use, including indications, effects, 
routes, methods, and frequency and duration of administration, and any 
relevant hazards, contraindications, side effects, and precautions under 
which practitioners licensed by law to administer the device can use the 
device safely and for the purpose for which it is intended, including 
all purposes for which it is advertised or represented:

[[Page 21]]

Provided, however, That such information may be omitted from the 
dispensing package if, but only if, the article is a device for which 
directions, hazards, warnings, and other information are commonly known 
to practitioners licensed by law to use the device. Upon written 
request, stating reasonable grounds therefor, the Commissioner will 
offer an opinion on a proposal to omit such information from the 
dispensing package under this proviso.
    (d) Any labeling, as defined in section 201(m) of the act, whether 
or not it is on or within a package from which the device is to be 
dispensed, distributed by or on behalf of the manufacturer, packer, or 
distributor of the device, that furnishes or purports to furnish 
information for use of the device contains adequate information for such 
use, including indications, effects, routes, methods, and frequency and 
duration of administration and any relevant hazards, contraindications, 
side effects, and precautions, under which practitioners licensed by law 
to employ the device can use the device safely and for the purposes for 
which it is intended, including all purposes for which it is advertised 
or represented. This information will not be required on so-called 
reminder--piece labeling which calls attention to the name of the device 
but does not include indications or other use information.
    (e) All labeling, except labels and cartons, bearing information for 
use of the device also bears the date of the issuance or the date of the 
latest revision of such labeling.



Sec. 801.110  Retail exemption for prescription devices.

    A device subject to Sec. 801.109 shall be exempt at the time of 
delivery to the ultimate purchaser or user from section 502(f)(1) of the 
act if it is delivered by a licensed practitioner in the course of his 
professional practice or upon a prescription or other order lawfully 
issued in the course of his professional practice, with labeling bearing 
the name and address of such licensed practitioner and the directions 
for use and cautionary statements, if any, contained in such order.



Sec. 801.116  Medical devices having commonly known directions.

    A device shall be exempt from section 502(f)(1) of the act insofar 
as adequate directions for common uses thereof are known to the ordinary 
individual.



Sec. 801.119  In vitro diagnostic products.

    A product intended for use in the diagnosis of disease and which is 
an in vitro diagnostic product as defined in Sec. 809.3(a) of this 
chapter shall be deemed to be in compliance with the requirements of 
this section and section 502(f)(1) of the act if it meets the 
requirements of Sec. 809.10 of this chapter.



Sec. 801.122  Medical devices for processing, repacking, or manufacturing.

    A device intended for processing, repacking, or use in the 
manufacture of another drug or device shall be exempt from section 
502(f)(1) of the act if its label bears the statement ``Caution: For 
manufacturing, processing, or repacking''.



Sec. 801.125  Medical devices for use in teaching, law enforcement, research, and analysis.

    A device subject to Sec. 801.109 shall be exempt from section 
502(f)(1) of this act if shipped or sold to, or in the possession of, 
persons regularly and lawfully engaged in instruction in pharmacy, 
chemistry, or medicine not involving clinical use, or engaged in law 
enforcement, or in research not involving clinical use, or in chemical 
analysis, or physical testing, and is to be used only for such 
instruction, law enforcement, research, analysis, or testing.



Sec. 801.127  Medical devices; expiration of exemptions.

    (a) If a shipment or delivery, or any part thereof, of a device 
which is exempt under the regulations in this section is made to a 
person in whose possession the article is not exempt, or is made for any 
purpose other than those specified, such exemption shall expire, with 
respect to such shipment or delivery or part thereof, at the beginning 
of that shipment or delivery. The causing

[[Page 22]]

of an exemption to expire shall be considered an act which results in 
such device being misbranded unless it is disposed of under 
circumstances in which it ceases to be a drug or device.
    (b) The exemptions conferred by Secs. 801.119, 801.122, and 801.125 
shall continue until the devices are used for the purposes for which 
they are exempted, or until they are relabeled to comply with section 
502(f)(1) of the act. If, however, the device is converted, or 
manufactured into a form limited to prescription dispensing, no 
exemption shall thereafter apply to the article unless the device is 
labeled as required by Sec. 801.109.



                       Subpart E--Other Exemptions



Sec. 801.150  Medical devices; processing, labeling, or repacking.

    (a) Except as provided by paragraphs (b) and (c) of this section, a 
shipment or other delivery of a device which is, in accordance with the 
practice of the trade, to be processed, labeled, or repacked, in 
substantial quantity at an establishment other than that where 
originally processed or packed, shall be exempt, during the time of 
introduction into and movement in interstate commerce and the time of 
holding in such establishment, from compliance with the labeling and 
packaging requirements of section 502(b) and (f) of the act if:
    (1) The person who introduced such shipment or delivery into 
interstate commerce is the operator of the establishment where such 
device is to be processed, labeled, or repacked; or
    (2) In case such person is not such operator, such shipment or 
delivery is made to such establishment under a written agreement, signed 
by and containing the post office addresses of such person and such 
operator, and containing such specifications for the processing, 
labeling, or repacking, as the case may be, of such device in such 
establishment as will insure, if such specifications are followed, that 
such device will not be adulterated or misbranded within the meaning of 
the act upon completion of such processing, labeling, or repacking. Such 
person and such operator shall each keep a copy of such agreement until 
2 years after the final shipment or delivery of such device from such 
establishment, and shall make such copies available for inspection at 
any reasonable hour to any officer or employee of the Department who 
requests them.
    (b) An exemption of a shipment or other delivery of a device under 
paragraph (a)(1) of this section shall, at the beginning of the act of 
removing such shipment or delivery, or any part thereof, from such 
establishment, become void ab initio if the device comprising such 
shipment, delivery, or part is adulterated or misbranded within the 
meaning of the act when so removed.
    (c) An exemption of a shipment or other delivery of a device under 
paragraph (a)(2) of this section shall become void ab initio with 
respect to the person who introduced such shipment or delivery into 
interstate commerce upon refusal by such person to make available for 
inspection a copy of the agreement, as required by such paragraph 
(a)(2).
    (d) An exemption of a shipment or other delivery of a device under 
paragraph (a)(2) of this section shall expire:
    (1) At the beginning of the act of removing such shipment or 
delivery, or any part thereof, from such establishment if the device 
comprising such shipment, delivery, or part is adulterated or misbranded 
within the meaning of the act when so removed; or
    (2) Upon refusal by the operator of the establishment where such 
device is to be processed, labeled, or repacked, to make available for 
inspection a copy of the agreement, as required by such clause.
    (e) As it is a common industry practice to manufacture and/or 
assemble, package, and fully label a device as sterile at one 
establishment and then ship such device in interstate commerce to 
another establishment or to a contract sterilizer for sterilization, the 
Food and Drug Administration will initiate no regulatory action against 
the device as misbranded or adulterated when the nonsterile device is 
labeled sterile, provided all the following conditions are met:
    (1) There is in effect a written agreement which:

[[Page 23]]

    (i) Contains the names and post office addresses of the firms 
involved and is signed by the person authorizing such shipment and the 
operator or person in charge of the establishment receiving the devices 
for sterilization.
    (ii) Provides instructions for maintaining proper records or 
otherwise accounting for the number of units in each shipment to insure 
that the number of units shipped is the same as the number received and 
sterilized.
    (iii) Acknowledges that the device is nonsterile and is being 
shipped for further processing, and
    (iv) States in detail the sterilization process, the gaseous mixture 
or other media, the equipment, and the testing method or quality 
controls to be used by the contract sterilizer to assure that the device 
will be brought into full compliance with the Federal Food, Drug, and 
Cosmetic Act.
    (2) Each pallet, carton, or other designated unit is conspicuously 
marked to show its nonsterile nature when it is introduced into and is 
moving in interstate commerce, and while it is being held prior to 
sterilization. Following sterilization, and until such time as it is 
established that the device is sterile and can be released from 
quarantine, each pallet, carton, or other designated unit is 
conspicuously marked to show that it has not been released from 
quarantine, e.g., ``sterilized--awaiting test results'' or an equivalent 
designation.

Subparts F-G  [Reserved]



          Subpart H--Special Requirements for Specific Devices



Sec. 801.405  Labeling of articles intended for lay use in the repairing and/or refitting of dentures.

    (a) The American Dental Association and leading dental authorities 
have advised the Food and Drug Administration of their concern regarding 
the safety of denture reliners, repair kits, pads, cushions, and other 
articles marketed and labeled for lay use in the repairing, refitting, 
or cushioning of ill-fitting, broken, or irritating dentures. It is the 
opinion of dental authorities and the Food and Drug Administration that 
to properly repair and properly refit dentures a person must have 
professional knowledge and specialized technical skill. Laymen cannot be 
expected to maintain the original vertical dimension of occlusion and 
the centric relation essential in the proper repairing or refitting of 
dentures. The continued wearing of improperly repaired or refitted 
dentures may cause acceleration of bone resorption, soft tissue 
hyperplasia, and other irreparable damage to the oral cavity. Such 
articles designed for lay use should be limited to emergency or 
temporary situations pending the services of a licensed dentist.
    (b) The Food and Drug Administration therefore regards such articles 
as unsafe and misbranded under the Federal Food, Drug, and Cosmetic Act, 
unless the labeling:
    (1)(i) Limits directions for use for denture repair kits to 
emergency repairing pending unavoidable delay in obtaining professional 
reconstruction of the denture;
    (ii) Limits directions for use for denture reliners, pads, and 
cushions to temporary refitting pending unavoidable delay in obtaining 
professional reconstruction of the denture;
    (2) Contains in a conspicuous manner the word ``emergency'' 
preceding and modifying each indication-for-use statement for denture 
repair kits and the word ``temporary'' preceding and modifying each 
indication-for-use statement for reliners, pads, and cushions; and
    (3) Includes a conspicuous warning statement to the effect:
    (i) For denture repair kits: ``Warning--For emergency repairs only. 
Long term use of home-repaired dentures may cause faster bone loss, 
continuing irritation, sores, and tumors. This kit for emergency use 
only. See Dentist Without Delay.''
    (ii) For denture reliners, pads, and cushions: ``Warning--For 
temporary use only. Longterm use of this product may lead to faster bone 
loss, continuing irritation, sores, and tumors. For Use Only Until a 
Dentist Can Be Seen.''
    (c) Adequate directions for use require full information of the 
temporary and emergency use recommended in order for the layman to 
understand the limitations of usefulness, the reasons

[[Page 24]]

therefor, and the importance of adhering to the warnings. Accordingly, 
the labeling should contain substantially the following information:
    (1) For denture repair kits: Special training and tools are needed 
to repair dentures to fit properly. Home-repaired dentures may cause 
irritation to the gums and discomfort and tiredness while eating. Long 
term use may lead to more troubles, even permanent changes in bones, 
teeth, and gums, which may make it impossible to wear dentures in the 
future. For these reasons, dentures repaired with this kit should be 
used only in an emergency until a dentist can be seen. Dentures that 
don't fit properly cause irritation and injury to the gums and faster 
bone loss, which is permanent. Dentures that don't fit properly cause 
gum changes that may require surgery for correction. Continuing 
irritation and injury may lead to cancer in the mouth. You must see your 
dentist as soon as possible.
    (2) For denture reliners, pads, and cushions: Use of these 
preparations or devices may temporarily decrease the discomfort; 
however, their use will not make the denture fit properly. Special 
training and tools are needed to repair a denture to fit properly. 
Dentures that do not fit properly cause irritation and injury to the 
gums and faster bone loss, which is permanent and may require a 
completely new denture. Changes in the gums caused by dentures that do 
not fit properly may require surgery for correction. Continuing 
irritation and injury may lead to cancer in the mouth. You must see your 
dentist as soon as possible.
    (3) If the denture relining or repairing material forms a permanent 
bond with the denture, a warning statement to the following effect 
should be included: ``This reliner becomes fixed to the denture and a 
completely new denture may be required because of its use.''
    (d) Labeling claims exaggerating the usefulness or the safety of the 
material or failing to disclose all facts relevant to the claims of 
usefulness will be regarded as false and misleading under sections 
201(n) and 502(a) of the Federal Food, Drug, and Cosmetic Act.
    (e) Regulatory action may be initiated with respect to any article 
found within the jurisdiction of the act contrary to the provisions of 
this policy statement after 90 days following the date of publication of 
this section in the Federal Register.



Sec. 801.410  Use of impact-resistant lenses in eyeglasses and sunglasses.

    (a) Examination of data available on the frequency of eye injuries 
resulting from the shattering of ordinary crown glass lenses indicates 
that the use of such lenses constitutes an avoidable hazard to the eye 
of the wearer.
    (b) The consensus of the ophthalmic community is that the number of 
eye injuries would be substantially reduced by the use in eyeglasses and 
sunglasses of impact-resistant lenses.
    (c)(1) To protect the public more adequately from potential eye 
injury, eyeglasses and sunglasses must be fitted with impact-resistant 
lenses, except in those cases where the physician or optometrist finds 
that such lenses will not fulfill the visual requirements of the 
particular patient, directs in writing the use of other lenses, and 
gives written notification thereof to the patient.
    (2) The physician or optometrist shall have the option of ordering 
glass lenses, plastic lenses, or laminated glass lenses made impact 
resistant by any method; however, all such lenses shall be capable of 
withstanding the impact test described in paragraph (d)(2) of this 
section.
    (3) Each finished impact-resistant glass lens for prescription use 
shall be individually tested for impact resistance and shall be capable 
of withstanding the impact test described in paragraph (d)(2) of this 
section. Raised multifocal lenses shall be impact resistant but need not 
be tested beyond initial design testing. Prism segment multifocal, slab-
off prism, lenticular cataract, iseikonic, depressed segment one-piece 
multifocal, bioconcave, myodisc and minus lenticular, custom laminate 
and cemented assembly lenses shall be impact resistant but need not be 
subjected to impact testing. To demonstrate that all other types of 
impact-resistant lenses, including impact-resistant laminated

[[Page 25]]

glass lenses (i.e., lenses other than those described in the three 
preceding sentences of this paragraph (c)(3)), are capable of 
withstanding the impact test described in this regulation, the 
manufacturer of these lenses shall subject to an impact test a 
statistically significant sampling of lenses from each production batch, 
and the lenses so tested shall be representative of the finished forms 
as worn by the wearer, including finished forms that are of minimal lens 
thickness and have been subjected to any treatment used to impart impact 
resistance. All nonprescription lenses and plastic prescription lenses 
tested on the basis of statistical significance shall be tested in 
uncut-finished or finished form.
    (d)(1) For the purpose of this regulation, the impact test described 
in paragraph (d)(2) of this section shall be the ``referee test,'' 
defined as ``one which will be utilized to determine compliance with a 
regulation.'' The referee test provides the Food and Drug Administration 
with the means of examining a medical device for performance and does 
not inhibit the manufacturer from using equal or superior test methods. 
A lens manufacturer shall conduct tests of lenses using the impact test 
described in paragraph (d)(2) of this section or any equal or superior 
test. Whatever test is used, the lenses shall be capable of withstanding 
the impact test described in paragraph (d)(2) of this section if the 
Food and Drug Administration examines them for performance.
    (2) In the impact test, a \5/8\-inch steel ball weighing 
approximately 0.56 ounce is dropped from a height of 50 inches upon the 
horizontal upper surface of the lens. The ball shall strike within a \5/
8\-inch diameter circle located at the geometric center of the lens. The 
ball may be guided but not restricted in its fall by being dropped 
through a tube extending to within approximately 4 inches of the lens. 
To pass the test, the lens must not fracture; for the purpose of this 
section, a lens will be considered to have fractured if it cracks 
through its entire thickness, including a laminar layer, if any, and 
across a complete diameter into two or more separate pieces, or if any 
lens material visible to the naked eyes becomes detached from the ocular 
surface. The test shall be conducted with the lens supported by a tube 
(1-inch inside diameter, 1\1/4\-inch outside diameter, and approximately 
1-inch high) affixed to a rigid iron or steel base plate. The total 
weight of the base plate and its rigidly attached fixtures shall be not 
less than 27 pounds. For lenses of small minimum diameter, a support 
tube having an outside diameter of less than 1\1/4\ inches may be used. 
The support tube shall be made of rigid acrylic plastic, steel, or other 
suitable substance and shall have securely bonded on the top edge a \1/
8\- by \1/8\-inch neoprene gasket having a hardness of 
40plus-minus5, as determined by ASTM Method D 1415-88, 
``Standard Test Method for Rubber Property--International Hardness'' a 
minimum tensile strength of 1,200 pounds, as determined by ASTM Method D 
412-97, Standard Test Methods for Vulcanized Rubber and Thermoplastic 
Rubbers and Thermoplastic Elastomers--Tension and a minimum ultimate 
elongation of 400 percent, as determined by ASTM Method D 412-68 (Both 
methods are incorporated by reference and are available from the 
American Society for Testing Materials, 100 Barr Harbor Dr., West 
Conshohocken, Philadelphia, PA 19428, or available for inspection at the 
Center for Devices and Radiological Health's Library, 9200 Corporate 
Blvd., Rockville, MD 10850, or at the Office of the Federal Register, 
800 North Capitol St., N.W., suite 700, Washington, DC. The diameter or 
contour of the lens support may be modified as necessary so that the \1/
8\- by \1/8\-inch neoprene gasket supports the lens at its periphery.
    (e) Copies of invoice(s), shipping document(s), and records of sale 
or distribution of all impact resistant lenses, including finished 
eyeglasses and sunglasses, shall be kept and maintained for a period of 
3 years; however, the names and addresses of individuals purchasing 
nonprescription eyeglasses and sunglasses at the retail level need not 
be kept and maintained by the retailer. The records kept in compliance 
with this paragraph shall be made available upon request at all 
reasonable hours by any officer or employee of the Food and Drug 
Administration or by any

[[Page 26]]

other officer or employee acting on behalf of the Secretary of Health 
and Human Services and such officer or employee shall be permitted to 
inspect and copy such records, to make such inventories of stock as he 
deems necessary, and otherwise to check the correctness of such 
inventories.
    (f) In addition, those persons conducting tests in accordance with 
paragraph (d) of this section shall maintain the results thereof and a 
description of the test method and of the test apparatus for a period of 
3 years. These records shall be made available upon request at any 
reasonable hour by any officer or employee acting on behalf of the 
Secretary of Health and Human Services. The persons conducting tests 
shall permit the officer or employee to inspect and copy the records, to 
make such inventories of stock as the officer or employee deems 
necessary, and otherwise to check the correctness of the inventories.
    (g) For the purpose of this section, the term ``manufacturer'' 
includes an importer for resale. Such importer may have the tests 
required by paragraph (d) of this section conducted in the country of 
origin but must make the results thereof available, upon request, to the 
Food and Drug Administration, as soon as practicable.
    (h) All lenses must be impact-resistant except when the physician or 
optometrist finds that impact-resistant lenses will not fulfill the 
visual requirements for a particular patient.
    (i) This statement of policy does not apply to contact lenses.

[41 FR 6896, Feb. 13, 1976, as amended at 44 FR 20678, Apr. 6, 1979; 47 
FR 9397, Mar. 5, 1982; 65 FR 3586, Jan. 24, 2000]

    Effective Date Note: At 65 FR 3586, Jan. 24, 2000, Secs. 801.410 was 
amended in paragraph (d)(2) by removing ``ASTM Method D 1415-68 Test for 
International Hardness of Vulcanized Rubber,'' and adding in its place 
``ASTM Method D 1415-88, Standard Test Method for Rubber Property--
International Hardness''; by removing ``ASTM Method D 412-68 Tension 
Test of Vulcanized Rubber,'' and adding in its place ``ASTM Method D 
412-97, Standard Test Methods for Vulcanized Rubber and Thermoplastic 
Rubbers and Thermoplastic Elastomers--Tension''; and by removing ``1916 
Race St., Philadelphia, PA 19103, or available for inspection at the 
Office of the Federal Register, 800 North Capitol Street, NW., suite 
700, Washington, DC 20408)'' and adding in its place ``100 Barr Harbor 
Dr., West Conshohocken, Philadelphia, PA 19428, or available for 
inspection at the Center for Devices and Radiological Health's Library, 
9200 Corporate Blvd., Rockville, MD 10850, or at the Office of the 
Federal Register, 800 North Capitol St., N.W., suite 700, Washington, 
DC.'', effective June 7, 2000.



Sec. 801.415  Maximum acceptable level of ozone.

    (a) Ozone is a toxic gas with no known useful medical application in 
specific, adjunctive, or preventive therapy. In order for ozone to be 
effective as a germicide, it must be present in a concentration far 
greater than that which can be safely tolerated by man and animals.
    (b) Although undesirable physiological effects on the central 
nervous system, heart, and vision have been reported, the predominant 
physiological effect of ozone is primary irritation of the mucous 
membranes. Inhalation of ozone can cause sufficient irritation to the 
lungs to result in pulmonary edema. The onset of pulmonary edema is 
usually delayed for some hours after exposure; thus, symptomatic 
response is not a reliable warning of exposure to toxic concentrations 
of ozone. Since olfactory fatigue develops readily, the odor of ozone is 
not a reliable index of atmospheric ozone concentration.
    (c) A number of devices currently on the market generate ozone by 
design or as a byproduct. Since exposure to ozone above a certain 
concentration can be injurious to health, any such device will be 
considered adulterated and/or misbranded within the meaning of sections 
501 and 502 of the act if it is used or intended for use under the 
following conditions:
    (1) In such a manner that it generates ozone at a level in excess of 
0.05 part per million by volume of air circulating through the device or 
causes an accumulation of ozone in excess of 0.05 part per million by 
volume of air (when measured under standard conditions at 25  deg.C (77 
deg.F) and 760 millimeters of mercury) in the atmosphere of enclosed 
space intended to be occupied by people for extended periods of time, 
e.g., houses, apartments, hospitals, and offices. This applies to any 
such device, whether portable or permanent or part

[[Page 27]]

of any system, which generates ozone by design or as an inadvertent or 
incidental product.
    (2) To generate ozone and release it into the atmosphere in 
hospitals or other establishments occupied by the ill or infirm.
    (3) To generate ozone and release it into the atmosphere and does 
not indicate in its labeling the maximum acceptable concentration of 
ozone which may be generated (not to exceed 0.05 part per million by 
volume of air circulating through the device) as established herein and 
the smallest area in which such device can be used so as not to produce 
an ozone accumulation in excess of 0.05 part per million.
    (4) In any medical condition for which there is no proof of safety 
and effectiveness.
    (5) To generate ozone at a level less than 0.05 part per million by 
volume of air circulating through the device and it is labeled for use 
as a germicide or deodorizer.
    (d) This section does not affect the present threshold limit value 
of 0.10 part per million (0.2 milligram per cubic meter) of ozone 
exposure for an 8-hour-day exposure of industrial workers as recommended 
by the American Conference of Governmental Industrial Hygienists.
    (e) The method and apparatus specified in 40 CFR part 50, or any 
other equally sensitive and accurate method, may be employed in 
measuring ozone pursuant to this section.



Sec. 801.417  Chlorofluorocarbon propellants.

    The use of chlorofluorocarbon in devices as propellants in self-
pressurized containers is generally prohibited except as provided in 
Sec. 2.125 of this chapter.

[43 FR 11318, Mar. 17, 1978]



Sec. 801.420  Hearing aid devices; professional and patient labeling.

    (a) Definitions for the purposes of this section and Sec. 801.421. 
(1) Hearing aid means any wearable instrument or device designed for, 
offered for the purpose of, or represented as aiding persons with or 
compensating for, impaired hearing.
    (2) Ear specialist means any licensed physician who specializes in 
diseases of the ear and is medically trained to identify the symptoms of 
deafness in the context of the total health of the patient, and is 
qualified by special training to diagnose and treat hearing loss. Such 
physicians are also known as otolaryngologists, otologists, and 
otorhinolaryngologists.
    (3) Dispenser means any person, partnership, corporation, or 
association engaged in the sale, lease, or rental of hearing aids to any 
member of the consuming public or any employee, agent, sales person, 
and/or representative of such a person, partnership, corporation, or 
association.
    (4) Audiologist means any person qualified by training and 
experience to specialize in the evaluation and rehabilitation of 
individuals whose communication disorders center in whole or in part in 
the hearing function. In some states audiologists must satisfy specific 
requirements for licensure.
    (5) Sale or purchase includes any lease or rental of a hearing aid 
to a member of the consuming public who is a user or prospective user of 
a hearing aid.
    (6) Used hearing aid means any hearing aid that has been worn for 
any period of time by a user. However, a hearing aid shall not be 
considered ``used'' merely because it has been worn by a prospective 
user as a part of a bona fide hearing aid evaluation conducted to 
determine whether to select that particular hearing aid for that 
prospective user, if such evaluation has been conducted in the presence 
of the dispenser or a hearing aid health professional selected by the 
dispenser to assist the buyer in making such a determination.
    (b) Label requirements for hearing aids. Hearing aids shall be 
clearly and permanently marked with:
    (1) The name of the manufacturer or distributor, the model name or 
number, the serial number, and the year of manufacture.
    (2) A ``+'' symbol to indicate the positive connection for battery 
insertion, unless it is physically impossible to insert the battery in 
the reversed position.
    (c) Labeling requirements for hearing aids--(1) General. All 
labeling information required by this paragraph shall

[[Page 28]]

be included in a User Instructional Brochure that shall be developed by 
the manufacturer or distributor, shall accompany the hearing aid, and 
shall be provided to the prospective user by the dispenser of the 
hearing aid in accordance with Sec. 801.421(c). The User Instructional 
Brochure accompanying each hearing aid shall contain the following 
information and instructions for use, to the extent applicable to the 
particular requirements and characteristics of the hearing aid:
    (i) An illustration(s) of the hearing aid, indicating operating 
controls, user adjustments, and battery compartment.
    (ii) Information on the function of all controls intended for user 
adjustment.
    (iii) A description of any accessory that may accompany the hearing 
aid, e.g., accessories for use with a television or telephone.
    (iv) Specific instructions for:
    (a) Use of the hearing aid.
    (b) Maintenance and care of the hearing aid, including the procedure 
to follow in washing the earmold, when replacing tubing on those hearing 
aids that use tubing, and in storing the hearing aid when it will not be 
used for an extended period of time.
    (c) Replacing or recharging the batteries, including a generic 
designation of replacement batteries.
    (v) Information on how and where to obtain repair service, including 
at least one specific address where the user can go, or send the hearing 
aid to, to obtain such repair service.
    (vi) A description of commonly occurring avoidable conditions that 
could adversely affect or damage the hearing aid, such as dropping, 
immersing, or exposing the hearing aid to excessive heat.
    (vii) Identification of any known side effects associated with the 
use of a hearing aid that may warrant consultation with a physician, 
e.g., skin irritation and accelerated accumulation of cerumen (ear wax).
    (viii) A statement that a hearing aid will not restore normal 
hearing and will not prevent or improve a hearing impairment resulting 
from organic conditions.
    (ix) A statement that in most cases infrequent use of a hearing aid 
does not permit a user to attain full benefit from it.
    (x) A statement that the use of a hearing aid is only part of 
hearing habilitation and may need to be supplemented by auditory 
training and instruction in lipreading.
    (xi) The warning statement required by paragraph (c)(2) of this 
section.
    (xii) The notice for prospective hearing aid users required by 
paragraph (c)(3) of this section.
    (xiii) The technical data required by paragraph (c)(4) of this 
section, unless such data is provided in separate labeling accompanying 
the device.
    (2) Warning statement. The User Instructional Brochure shall contain 
the following warning statement:

                    Warning to Hearing Aid Dispensers

    A hearing aid dispenser should advise a prospective hearing aid user 
to consult promptly with a licensed physician (preferably an ear 
specialist) before dispensing a hearing aid if the hearing aid dispenser 
determines through inquiry, actual observation, or review of any other 
available information concerning the prospective user, that the 
prospective user has any of the following conditions:
    (i) Visible congenital or traumatic deformity of the ear.
    (ii) History of active drainage from the ear within the previous 90 
days.
    (iii) History of sudden or rapidly progressive hearing loss within 
the previous 90 days.
    (iv) Acute or chronic dizziness.
    (v) Unilateral hearing loss of sudden or recent onset within the 
previous 90 days.
    (vi) Audiometric air-bone gap equal to or greater than 15 decibels 
at 500 hertz (Hz), 1,000 Hz, and 2,000 Hz.
    (vii) Visible evidence of significant cerumen accumulation or a 
foreign body in the ear canal.
    (viii) Pain or discomfort in the ear.
    Special care should be exercised in selecting and fitting a hearing 
aid whose maximum sound pressure level exceeds 132 decibels because 
there may be risk of impairing the remaining hearing of the hearing aid 
user. (This provision is required only for those hearing aids with a 
maximum sound pressure capability greater than 132 decibels (dB).)

    (3) Notice for prospective hearing aid users. The User Instructional 
Brochure shall contain the following notice:

[[Page 29]]

           Important Notice for Prospective Hearing Aid Users

    Good health practice requires that a person with a hearing loss have 
a medical evaluation by a licensed physician (preferably a physician who 
specializes in diseases of the ear) before purchasing a hearing aid. 
Licensed physicians who specialize in diseases of the ear are often 
referred to as otolaryngologists, otologists or otorhinolaryngologists. 
The purpose of medical evaluation is to assure that all medically 
treatable conditions that may affect hearing are identified and treated 
before the hearing aid is purchased.
    Following the medical evaluation, the physician will give you a 
written statement that states that your hearing loss has been medically 
evaluated and that you may be considered a candidate for a hearing aid. 
The physician will refer you to an audiologist or a hearing aid 
dispenser, as appropriate, for a hearing aid evaluation.
    The audiologist or hearing aid dispenser will conduct a hearing aid 
evaluation to assess your ability to hear with and without a hearing 
aid. The hearing aid evaluation will enable the audiologist or dispenser 
to select and fit a hearing aid to your individual needs.
    If you have reservations about your ability to adapt to 
amplification, you should inquire about the availability of a trial-
rental or purchase-option program. Many hearing aid dispensers now offer 
programs that permit you to wear a hearing aid for a period of time for 
a nominal fee after which you may decide if you want to purchase the 
hearing aid.
    Federal law restricts the sale of hearing aids to those individuals 
who have obtained a medical evaluation from a licensed physician. 
Federal law permits a fully informed adult to sign a waiver statement 
declining the medical evaluation for religious or personal beliefs that 
preclude consultation with a physician. The exercise of such a waiver is 
not in your best health interest and its use is strongly discouraged.

                       children with hearing loss

    In addition to seeing a physician for a medical evaluation, a child 
with a hearing loss should be directed to an audiologist for evaluation 
and rehabilitation since hearing loss may cause problems in language 
development and the educational and social growth of a child. An 
audiologist is qualified by training and experience to assist in the 
evaluation and rehabilitation of a child with a hearing loss.

    (4) Technical data. Technical data useful in selecting, fitting, and 
checking the performance of a hearing aid shall be provided in the User 
Instructional Brochure or in separate labeling that accompanies the 
device. The determination of technical data values for the hearing aid 
labeling shall be conducted in accordance with the test procedures of 
the American National Standard ``Specification of Hearing Aid 
Characteristics,'' ANSI S3.22-1996 (ASA 70-1996) (Revision of ANSI 
S3.22-1987), which is incorporated by reference in accordance with 5 
U.S.C. 552(a) and 1 CFR part 51. Copies are available from the Standards 
Secretariat of the Acoustical Society of America, 120 Wall St., New 
York, NY 10005-3993, or are available for inspection at the Regulations 
Staff, CDRH (HFZ-215), FDA, 1350 Piccard Dr., rm. 240, Rockville, MD 
20850, and at the Office of the Federal Register, 800 North Capitol St. 
NW., Suite 700, Washington, DC. As a minimum, the User Instructional 
Brochure or such other labeling shall include the appropriate values or 
information for the following technical data elements as these elements 
are defined or used in such standard:
    (i) Saturation output curve (SSPL 90 curve).
    (ii) Frequency response curve.
    (iii) Average saturation output (HF-Average SSPL 90).
    (iv) Average full-on gain (HF-Average full-on gain).
    (v) Reference test gain.
    (vi) Frequency range.
    (vii) Total harmonic distortion.
    (viii) Equivalent input noise.
    (ix) Battery current drain.
    (x) Induction coil sensitivity (telephone coil aids only).
    (xi) Input-output curve (ACG aids only).
    (xii) Attack and release times (ACG aids only).
    (5) Statement if hearing aid is used or rebuilt. If a hearing aid 
has been used or rebuilt, this fact shall be declared on the container 
in which the hearing aid is packaged and on a tag that is physically 
attached to such hearing aid. Such fact may also be stated in the User 
Instructional Brochure.
    (6) Statements in User Instructional Brochure other than those 
required. A User Instructional Brochure may contain statements or 
illustrations in addition to those required by paragraph

[[Page 30]]

(c) of this section if the additional statements:
    (i) Are not false or misleading in any particular, e.g., diminishing 
the impact of the required statements; and
    (ii) Are not prohibited by this chapter or by regulations of the 
Federal Trade Commission.
    (d) Submission of all labeling for each type of hearing aid. Any 
manufacturer of a hearing aid described in paragraph (a) of this section 
shall submit to the Food and Drug Administration, Bureau of Medical 
Devices and Diagnostic Products, Division of Compliance, HFK-116, 8757 
Georgia Ave., Silver Spring, MD 20910, a copy of the User Instructional 
Brochure described in paragraph (c) of this section and all other 
labeling for each type of hearing aid on or before August 15, 1977.

[42 FR 9294, Feb. 15, 1977, as amended at 47 FR 9398, Mar. 5, 1982; 50 
FR 30154, July 24, 1985; 54 FR 52396, Dec. 21, 1989; 64 FR 59620, Nov. 
3, 1999]



Sec. 801.421  Hearing aid devices; conditions for sale.

    (a) Medical evaluation requirements--(1) General. Except as provided 
in paragraph (a)(2) of this section, a hearing aid dispenser shall not 
sell a hearing aid unless the prospective user has presented to the 
hearing aid dispenser a written statement signed by a licensed physician 
that states that the patient's hearing loss has been medically evaluated 
and the patient may be considered a candidate for a hearing aid. The 
medical evaluation must have taken place within the preceding 6 months.
    (2) Waiver to the medical evaluation requirements. If the 
prospective hearing aid user is 18 years of age or older, the hearing 
aid dispenser may afford the prospective user an opportunity to waive 
the medical evaluation requirement of paragraph (a)(1) of this section 
provided that the hearing aid dispenser:
    (i) Informs the prospective user that the exercise of the waiver is 
not in the user's best health interest;
    (ii) Does not in any way actively encourage the prospective user to 
waive such a medical evaluation; and
    (iii) Affords the prospective user the opportunity to sign the 
following statement:

    I have been advised by ________ ________ (Hearing aid dispenser's 
name) that the Food and Drug Administration has determined that my best 
health interest would be served if I had a medical evaluation by a 
licensed physician (preferably a physician who specializes in diseases 
of the ear) before purchasing a hearing aid. I do not wish a medical 
evaluation before purchasing a hearing aid.

    (b) Opportunity to review User Instructional Brochure. Before 
signing any statement under paragraph (a)(2)(iii) of this section and 
before the sale of a hearing aid to a prospective user, the hearing aid 
dispenser shall:
    (1) Provide the prospective user a copy of the User Instructional 
Brochure for a hearing aid that has been, or may be selected for the 
prospective user;
    (2) Review the content of the User Instructional Brochure with the 
prospective user orally, or in the predominate method of communication 
used during the sale;
    (3) Afford the prospective user an opportunity to read the User 
Instructional Brochure.
    (c) Availability of User Instructional Brochure. (1) Upon request by 
an individual who is considering purchase of a hearing aid, a dispenser 
shall, with respect to any hearing aid that he dispenses, provide a copy 
of the User Instructional Brochure for the hearing aid or the name and 
address of the manufacturer or distributor from whom a User 
Instructional Brochure for the hearing aid may be obtained.
    (2) In addition to assuring that a User Instructional Brochure 
accompanies each hearing aid, a manufacturer or distributor shall with 
respect to any hearing aid that he manufactures or distributes:
    (i) Provide sufficient copies of the User Instructional Brochure to 
sellers for distribution to users and prospective users;
    (ii) Provide a copy of the User Instructional Brochure to any 
hearing aid professional, user, or prospective user who requests a copy 
in writing.
    (d) Recordkeeping. The dispenser shall retain for 3 years after the 
dispensing of a hearing aid a copy of any written statement from a 
physician required under paragraph (a)(1) of this section

[[Page 31]]

or any written statement waiving medical evaluation required under 
paragraph (a)(2)(iii) of this section.
    (e) Exemption for group auditory trainers. Group auditory trainers, 
defined as a group amplification system purchased by a qualified school 
or institution for the purpose of communicating with and educating 
individuals with hearing impairments, are exempt from the requirements 
of this section.

[42 FR 9296, Feb. 15, 1977]



Sec. 801.430  User labeling for menstrual tampons.

    (a) This section applies to scented or scented deodorized menstrual 
tampons as identified in Sec. 884.5460 and unscented menstrual tampons 
as identified in Sec. 884.5470 of this chapter.
    (b) Data show that toxic shock syndrome (TSS), a rare but serious 
and sometimes fatal disease, is associated with the use of menstrual 
tampons. To protect the public and to minimize the serious adverse 
effects of TSS, menstrual tampons shall be labeled as set forth in 
paragraphs (c), (d), and (e) of this section and tested for absorbency 
as set forth in paragraph (f) of this section.
    (c) If the information specified in paragraph (d) of this section is 
to be included as a package insert, the following alert statement shall 
appear prominently and legibly on the package label:

    Attention: Tampons are associated with Toxic Shock Syndrome (TSS). 
TSS is a rare but serious disease that may cause death. Read and save 
the enclosed information.

    (d) The labeling of menstrual tampons shall contain the following 
consumer information prominently and legibly, in such terms as to render 
the information likely to be read and understood by the ordinary 
individual under customary conditions of purchase and use:
    (1)(i) Warning signs of TSS, e.g., sudden fever (usually 102 deg. or 
more) and vomiting, diarrhea, fainting or near fainting when standing 
up, dizziness, or a rash that looks like a sunburn;
    (ii) What to do if these or other signs of TSS appear, including the 
need to remove the tampon at once and seek medical attention 
immediately;
    (2) The risk of TSS to all women using tampons during their 
menstrual period, especially the reported higher risks to women under 30 
years of age and teenage girls, the estimated incidence of TSS of 1 to 
17 per 100,000 menstruating women and girls per year, and the risk of 
death from contracting TSS;
    (3) The advisability of using tampons with the minimum absorbency 
needed to control menstrual flow in order to reduce the risk of 
contracting TSS;
    (4) Avoiding the risk of getting tampon-associated TSS by not using 
tampons, and reducing the risk of getting TSS by alternating tampon use 
with sanitary napkin use during menstrual periods; and
    (5) The need to seek medical attention before again using tampons if 
TSS warning signs have occurred in the past, or if women have any 
questions about TSS or tampon use.
    (e) The statements required by paragraph (e) of this section shall 
be prominently and legibly placed on the package label of menstrual 
tampons in conformance with section 502(c) of the Federal Food, Drug, 
and Cosmetic Act (the act) (unless the menstrual tampons are exempt 
under paragraph (g) of this section).
    (1) Menstrual tampon package labels shall bear one of the following 
absorbency terms representing the absorbency of the production run, lot, 
or batch as measured by the test described in paragraph (f)(2) of this 
section;

------------------------------------------------------------------------
                                                Corresponding term of
     Ranges of absorbency in grams \1\               absorbency
------------------------------------------------------------------------
6 and under...............................  Junior absorbency.
6 to 9....................................  Regular absorbency.
9 to 12...................................  Super absorbency.
12 to 15..................................  Super plus absorbency.
15 to 18..................................  None.
above 18..................................  None.
------------------------------------------------------------------------
\1\ These ranges are defined, respectively, as follows: less than or
  equal to 6 grams; greater than 6 grams up to and including 9 grams;
  greater than 9 grams up to and including 12 grams; greater than 12
  grams up to and including 15 grams; greater than 15 grams up to and
  including 18 grams; and greater than 18 grams.

    (2) The package label shall include an explanation of the ranges of 
absorbency and a description of how consumers can use a range of 
absorbency, and its corresponding absorbency term, to make comparisons 
of absorbency of

[[Page 32]]

tampons to allow selection of the tampons with the minimum absorbency 
needed to control menstrual flow in order to reduce the risk of 
contracting TSS.
    (f) A manufacturer shall measure the absorbency of individual 
tampons using the test method specified in paragraph (f)(2) of this 
section and calculate the mean absorbency of a production run, lot, or 
batch by rounding to the nearest 0.1 gram.
    (1) A manufacturer shall design and implement a sampling plan that 
includes collection of probability samples of adequate size to yield 
consistent tolerance intervals such that the probability is 90 percent 
that at least 90 percent of the absorbencies of individual tampons 
within a brand and type are within the range of absorbency stated on the 
package label.
    (2) In the absorbency test, an unlubricated condom, with tensile 
strength between 17 Mega Pascals (MPa) and 30 MPa, as measured according 
to the procedure in the American Society for Testing and Materials 
(ASTM) D 3492-96, `Standard Specification for Rubber Contraceptives 
(Male Condoms)' \1\ for determining tensile strength, which is 
incorporated by reference in accordance with 5 U.S.C. 552(a), is 
attached to the large end of a glass chamber (or a chamber made from 
hard transparent plastic) with a rubber band (see figure 1) and pushed 
through the small end of the chamber using a smooth, finished rod. The 
condom is pulled through until all slack is removed. The tip of the 
condom is cut off and the remaining end of the condom is stretched over 
the end of the tube and secured with a rubber band. A preweighed (to the 
nearest 0.01 gram) tampon is placed within the condom membrane so that 
the center of gravity of the tampon is at the center of the chamber. An 
infusion needle (14 gauge) is inserted through the septum created by the 
condom tip until it contacts the end of the tampon. The outer chamber is 
filled with water pumped from a temperature-controlled waterbath to 
maintain the average temperature at 271  deg.C. The water 
returns to the waterbath as shown in figure 2. Syngyna fluid (10 grams 
sodium chloride, 0.5 gram Certified Reagent Acid Fushsin, 1,000 
milliliters distilled water) is then pumped through the infusion needle 
at a rate of 50 milliliters per hour. The test shall be terminated when 
the tampon is saturated and the first drop of fluid exits the apparatus. 
(The test result shall be discarded if fluid is detected in the folds of 
the condom before the tampon is saturated). The water is then drained 
and the tampon is removed and immediately weighed to the nearest 0.01 
gram. The absorbency of the tampon is determined by subtracting its dry 
weight from this value. The condom shall be replaced after 10 tests or 
at the end of the day during which the condom is used in testing, 
whichever occurs first.
---------------------------------------------------------------------------

    \1\ Copies of the standard are available from the American Society 
for Testing and Materials, 100 Barr Harbor Dr., West Conshohocken, PA 
19428, or available for inspection at the Center for Devices and 
Radiological Health's Library, 9200 Corporate Blvd., Rockville, MD 
10850, or at the Office of the Federal Register, 800 North Capitol St. 
NW., suite 700, Washington, DC.

---------------------------------------------------------------------------

[[Page 33]]

[GRAPHIC] [TIFF OMITTED] TR01FE93.026


[[Page 34]]


[GRAPHIC] [TIFF OMITTED] TR01FE93.027

    (3) The Food and Drug Administration may permit the use of an 
absorbency test method different from the test method specified in this 
section if each of the following conditions is met:
    (i) The manufacturer presents evidence, in the form of a citizen 
petition

[[Page 35]]

submitted in accordance with the requirements of Sec. 10.30 of this 
chapter, demonstrating that the alternative test method will yield 
results that are equivalent to the results yielded by the test method 
specified in this section; and
    (ii) FDA approves the method and has published notice of its 
approval of the alternative test method in the Federal Register.
    (g) Any menstrual tampon intended to be dispensed by a vending 
machine is exempt from the requirements of this section.
    (h) Any menstrual tampon that is not labeled as required by 
paragraphs (c), (d), and (e) of this section and that is initially 
introduced or initially delivered for introduction into commerce after 
March 1, 1990, is misbranded under sections 201(n), 502 (a) and (f) of 
the act.

(Information collection requirements contained in paragraphs (e) and (f) 
were approved by the Office of Management and Budget under control 
number 0910-0257)

[47 FR 26989, June 22, 1982, as amended at 54 FR 43771, Oct. 26, 1989; 
55 FR 17600, Apr. 26, 1990; 65 FR 3586, Jan. 24, 2000]

    Effective Date Note: AT 65 FR 3586, Jan. 24, 2000, Secs. 801.430 was 
amended in paragraph (f)(2) by removing ``(ASTM), D 3492-83, `Standard 
Specification for Rubber Contraceptives (Condoms)' '' and by adding in 
its place ``(ASTM) D 3492-96, `Standard Specification for Rubber 
Contraceptives (Male Condoms)' ''; and by revising the footnote 
effective June 7, 2000. For the convenience of the user, the superseded 
text follows.

Sec. 801.430  User labeling for menstrual tampons.

                                * * * * *

    \1\ Copies of the standard are available from the American Society 
for Testing and Materials, 1916 Race St., Philadelphia, PA 19103, or 
available for inspection at the Office of the Federal Register, 800 
North Capitol Street NW., suite 700, Washington, DC.

                                * * * * *



Sec. 801.433  Warning statements for prescription and restricted device products containing or manufactured with chlorofluorocarbons or other ozone-depleting 
          substances.

    (a)(1) All prescription and restricted device products containing or 
manufactured with chlorofluorocarbons, halons, carbon tetrachloride, 
methyl chloride, or any other class I substance designated by the 
Environmental Protection Agency (EPA) shall, except as provided in 
paragraph (b) of this section, bear the following warning statement:

    Warning: Contains [or Manufactured with, if applicable] [insert name 
of substance], a substance which harms public health and environment by 
destroying ozone in the upper atmosphere.

    (2) The warning statement shall be clearly legible and conspicuous 
on the product, its immediate container, its outer packaging, or other 
labeling in accordance with the requirements of 40 CFR part 82 and 
appear with such prominence and conspicuousness as to render it likely 
to be read and understood by consumers under normal conditions of 
purchase.
    (b)(1) For prescription and restricted device products, the 
following alternative warning statement may be used:
    Note: The indented statement below is required by the Federal 
government's Clean Air Act for all products containing or manufactured 
with chlorofluorocarbons (CFC's) [or name of other class I substance, if 
applicable]:

    This product contains [or is manufactured with, if applicable] 
[insert name of substance], a substance which harms the environment by 
destroying ozone in the upper atmosphere.
    Your physician has determined that this product is likely to help 
your personal health. USE THIS PRODUCT AS DIRECTED, UNLESS INSTRUCTED TO 
DO OTHERWISE BY YOUR PHYSICIAN. If you have any questions about 
alternatives, consult with your physician.
    (2) The warning statement shall be clearly legible and conspicuous 
on the product, its immediate container, its outer packaging, or other 
labeling in accordance with the requirements of 40 CFR part 82 and 
appear with such prominence and conspicuousness as to

[[Page 36]]

render it likely to be read and understood by consumers under normal 
conditions of purchase.
    (3) If the warning statement in paragraph (b)(1) of this section is 
used, the following warning statement must be placed on the package 
labeling intended to be read by the physician (physician package insert) 
after the ``How supplied'' section, which describes special handling and 
storage conditions on the physician labeling:
    Note: The indented statement below is required by the Federal 
government's Clean Air Act for all products containing or manufactured 
with chlorofluorocarbons (CFC's) [or name of other class I substance, if 
applicable]:

    Warning: Contains [or Manufactured with, if applicable] [insert name 
of substance], a substance which harms public health and environment by 
destroying ozone in the upper atmosphere.

    A notice similar to the above WARNING has been placed in the 
information for the patient [or patient information leaflet, if 
applicable] of this product under Environmental Protection Agency (EPA) 
regulations. The patient's warning states that the patient should 
consult his or her physician if there are questions about alternatives.
    (c) This section does not replace or relieve a person from any 
requirements imposed under 40 CFR part 82.

[61 FR 20101, May 3, 1996]



Sec. 801.435   User labeling for latex condoms.

    (a) This section applies to the subset of condoms as identified in 
Sec. 884.5300 of this chapter, and condoms with spermicidal lubricant as 
identified in Sec. 884.5310 of this chapter, which products are formed 
from latex films.
    (b) Data show that the material integrity of latex condoms degrade 
over time. To protect the public health and minimize the risk of device 
failure, latex condoms must bear an expiration date which is supported 
by testing as described in paragraphs (d) and (h) of this section.
    (c) The expiration date, as demonstrated by testing procedures 
required by paragraphs (d) and (h) of this section, must be displayed 
prominently and legibly on the primary packaging (i.e., individual 
package), and higher levels of packaging (e.g., boxes of condoms), in 
order to ensure visibility of the expiration date by consumers.
    (d) Except as provided under paragraph (f) of this section, the 
expiration date must be supported by data demonstrating physical and 
mechanical integrity of the product after three discrete and 
representative lots of the product have been subjected to each of the 
following conditions:
    (1) Storage of unpackaged bulk product for the maximum amount of 
time the manufacturer allows the product to remain unpackaged, followed 
by storage of the packaged product at 70 1/2C (plus or minus 2 1/2C) for 
7 days;
    (2) Storage of unpackaged bulk product for the maximum amount of 
time the manufacturer allows the product to remain unpackaged, followed 
by storage of the packaged product at a selected temperature between 40 
and 50 1/2C (plus or minus 2 1/2C) for 90 days; and
    (3) Storage of unpackaged bulk product for the maximum amount of 
time the manufacturer allows the product to remain unpackaged, followed 
by storage of the packaged product at a monitored or controlled 
temperature between 15 and 30 1/2C for the lifetime of the product (real 
time storage).
    (e) If a product fails the physical and mechanical integrity tests 
commonly used by industry after the completion of the accelerated 
storage tests described in paragraphs (d)(1) and (d)(2) of this section, 
the product expiration date must be demonstrated by real time storage 
conditions described in paragraph (d)(3) of this section. If all of the 
products tested after storage at temperatures as described in paragraphs 
(d)(1) and (d)(2) of this section pass the manufacturer's physical and 
mechanical integrity tests, the manufacturer may label the product with 
an expiration date of up to 5 years from the date of product packaging. 
If the extrapolated expiration date under paragraphs (d)(1) and (d)(2) 
of this section is used, the labeled expiration date must be confirmed 
by physical and mechanical integrity tests performed at the end of the 
stated expiration period as described in paragraph (d)(3) of this 
section. If the data from tests following real time storage described in 
paragraph (d)(3) of this section fails to confirm the extrapolated 
expiration

[[Page 37]]

date, the manufacturer must, at that time, relabel the product to 
reflect the actual shelf life.
    (f) Products that already have established shelf life data based 
upon real time storage and testing and have such storage and testing 
data available for inspection are not required to confirm such data 
using accelerated and intermediate aging data described in paragraphs 
(d)(1) and (d)(2) of this section. If, however, such real time 
expiration dates were based upon testing of products that were not first 
left unpackaged for the maximum amount of time as described in paragraph 
(d)(3) of this section, the real time testing must be confirmed by 
testing products consistent with the requirements of paragraph (d)(3) of 
this section. This testing shall be initiated no later than the 
effective date of this regulation. Until the confirmation testing in 
accordance with paragraph (d)(3) of this section is completed, the 
product may remain on the market labeled with the expiration date based 
upon previous real time testing.
    (g) If a manufacturer uses testing data from one product to support 
expiration dating on any variation of that product, the manufacturer 
must document and provide, upon request, an appropriate justification 
for the application of the testing data to the variation of the tested 
product.
    (h) If a latex condom contains a spermicide, and the expiration date 
based on spermicidal stability testing is different from the expiration 
date based upon latex integrity testing, the product shall bear only the 
earlier expiration date.
    (i) The time period upon which the expiration date is based shall 
start with the date of packaging.
    (j) As provided in part 820 of this chapter, all testing data must 
be retained in each company's files, and shall be made available upon 
request for inspection by the Food and Drug Administration.
    (k) Any latex condom not labeled with an expiration date as required 
by paragraph (c) of this section, and initially delivered for 
introduction into interstate commerce after the effective date of this 
regulation is misbranded under sections 201(n) and 502(a) and (f) of 
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 321(n) and 352(a) and 
(f)).

[62 FR 50501, Sept. 26, 1997]



Sec. 801.437  User labeling for devices that contain natural rubber.

    (a) Data in the Medical Device Reporting System and the scientific 
literature indicate that some individuals are at risk of severe 
anaphylactic reactions to natural latex proteins. This labeling 
regulation is intended to minimize the risk to individuals sensitive to 
natural latex proteins and protect the public health.
    (b) This section applies to all devices composed of or containing, 
or having packaging or components that are composed of, or contain, 
natural rubber that contacts humans. The term ``natural rubber'' 
includes natural rubber latex, dry natural rubber, and synthetic latex 
or synthetic rubber that contains natural rubber in its formulation.
    (1) The term ``natural rubber latex'' means rubber that is produced 
by the natural rubber latex process that involves the use of natural 
latex in a concentrated colloidal suspension. Products are formed from 
natural rubber latex by dipping, extruding, or coating.
    (2) The term ``dry natural rubber'' means rubber that is produced by 
the dry natural rubber process that involves the use of coagulated 
natural latex in the form of dried or milled sheets. Products are formed 
from dry natural rubber by compression molding, extrusion, or by 
converting the sheets into a solution for dipping.
    (3) The term ``contacts humans'' means that the natural rubber 
contained in a device is intended to contact or is likely to contact the 
user or patient. This includes contact when the device that contains 
natural rubber is connected to the patient by a liquid path or an 
enclosed gas path; or the device containing the natural rubber is fully 
or partially coated with a powder, and such powder may carry natural 
rubber proteins that may contaminate the environment of the user or 
patient.
    (c) Devices containing natural rubber shall be labeled as set forth 
in paragraphs (d) through (h) of this section. Each required labeling 
statement shall be prominently and legibly displayed

[[Page 38]]

in conformance with section 502(c) of the Federal Food, Drug, and 
Cosmetic Act (the act) (21 U.S.C. 352(c)).
    (d) Devices containing natural rubber latex that contacts humans, as 
described in paragraph (b) of this section, shall bear the following 
statement in bold print on the device labeling:
    ``Caution: This Product Contains Natural Rubber Latex Which May 
Cause Allergic Reactions.''

This statement shall appear on all device labels, and other labeling, 
and shall appear on the principal display panel of the device packaging, 
the outside package, container or wrapper, and the immediate device 
package, container, or wrapper.
    (e) Devices containing dry natural rubber that contacts humans, as 
described in paragraph (b) of this section, that are not already subject 
to paragraph (d) of this section, shall bear the following statement in 
bold print on the device labeling:
    ``This Product Contains Dry Natural Rubber.''

This statement shall appear on all device labels, and other labeling, 
and shall appear on the principal display panel of the device packaging, 
the outside package, container or wrapper, and the immediate device 
package, container, or wrapper.
    (f) Devices that have packaging containing natural rubber latex that 
contacts humans, as described in paragraph (b) of this section, shall 
bear the following statement in bold print on the device labeling:
    ``Caution: The Packaging of This Product Contains Natural Rubber 
Latex Which May Cause Allergic Reactions.''

This statement shall appear on the packaging that contains the natural 
rubber, and the outside package, container, or wrapper.
    (g) Devices that have packaging containing dry natural rubber that 
contacts humans, as described in paragraph (b) of this section, shall 
bear the following statement in bold print on the device labeling:
    ``The Packaging of This Product Contains Dry Natural Rubber.''

This statement shall appear on the packaging that contains the natural 
rubber, and the outside package, container, or wrapper.-
    (h) Devices that contain natural rubber that contacts humans, as 
described in paragraph (b) of this section, shall not contain the term 
``hypoallergenic'' on their labeling.
    (i) Any affected person may request an exemption or variance from 
the requirements of this section by submitting a citizen petition in 
accordance with Sec. 10.30 of this chapter.
    (j) Any device subject to this section that is not labeled in 
accordance with paragraphs (d) through (h) of this section and that is 
initially introduced or initially delivered for introduction into 
interstate commerce after the effective date of this regulation is 
misbranded under sections 201(n) and 502(a), (c), and (f) of the act (21 
U.S.C. 321(n) and 352(a), (c), and (f)).
    Note to Sec. 801.437: Paragraphs (f) and (g) are stayed until June 
27, 1999, as those regulations relate to device packaging that uses 
``cold seal'' adhesives.

[62 FR 51029, Sept. 30, 1997, as amended at 63 FR 46175, Aug. 31, 1998]



PART 803--MEDICAL DEVICE REPORTING--Table of Contents




                      Subpart A--General Provisions

Sec.
803.1  Scope.
803.3  Definitions.
803.9  Public availability of reports.
803.10  General description of reports required from user facilities, 
          importers, and manufacturers.
803.11  Obtaining the forms.
803.12  Where to submit reports.
803.13  English reporting requirement.
803.14  Electronic reporting.
803.15  Requests for additional information.
803.16  Disclaimers.
803.17  Written MDR procedures.
803.18  Files and distributor records.
803.19  Exemptions, variances, and alternative reporting requirements.

  Subpart B--Generally Applicable Requirements for Individual Adverse 
                              Event Reports

803.20  How to report.
803.21  Reporting codes.
803.22  When not to file.

[[Page 39]]

             Subpart C--User Facility Reporting Requirements

803.30  Individual adverse event reports; user facilities.
803.32  Individual adverse event report data elements.
803.33  Annual reports.

               Subpart D-- Importer Reporting Requirement

803.40  Individual adverse event reporting requirements; importers.
803.42  Individual adverse event report data elements.

             Subpart E--Manufacturer Reporting Requirements

803.50  Individual adverse event reports; manufacturers.
803.52  Individual adverse event report data elements.
803.53  Five-day reports.
803.55  Baseline reports.
803.56  Supplemental reports.
803.58  Foreign manufacturers.

    Authority: 21 U.S.C. 352, 360, 360i, 360j, 371, 374.

    Source: 60 FR 63597, Dec. 11, 1995, unless otherwise noted.



                      Subpart A--General Provisions



Sec. 803.1  Scope.

    (a) This part establishes requirements for medical device reporting. 
Under this part, device user facilities, importers, and manufacturers, 
as defined in Sec. 803.3, must report deaths and serious injuries to 
which a device has or may have caused or contributed, must establish and 
maintain adverse event files, and must submit to FDA specified followup 
and summary reports. Medical device distributors, as defined in 
Sec. 803.3, are also required to maintain records of incidents (files). 
Furthermore, manufacturers and importers are also required to report 
certain device malfunctions. These reports will assist FDA in protecting 
the public health by helping to ensure that devices are not adulterated 
or misbranded and are safe and effective for their intended use.
    (b) This part supplements and does not supersede other provisions of 
this subchapter, including the provisions of part 820 of this chapter.
    (c) References in this part to regulatory sections of the Code of 
Federal Regulations are to chapter I of title 21, unless otherwise 
noted.

[60 FR 63597, Dec. 11, 1995, as amended at 62 FR 13306, Mar. 20, 1997; 
65 FR 4118, Jan. 26, 2000]



Sec. 803.3  Definitions.

    (a) Act means the Federal Food, Drug, and Cosmetic Act.
    (b) Ambulatory surgical facility (ASF) means a distinct entity that 
operates for the primary purpose of furnishing same day outpatient 
surgical services to patients. An ASF may be either an independent 
entity (i.e., not a part of a provider of services or any other 
facility) or operated by another medical entity (e.g., under the common 
ownership, licensure or control of an entity). An ASF is subject to this 
regulation regardless of whether it is licensed by a Federal, State, 
municipal, or local government or regardless of whether it is accredited 
by a recognized accreditation organization. If an adverse event meets 
the criteria for reporting, the ASF must report that event regardless of 
the nature or location of the medical service provided by the ASF.
    (c) Become aware means that an employee of the entity required to 
report has acquired information reasonably suggesting a reportable 
adverse event has occurred.
    (1) Device user facilities are considered to have ``become aware'' 
when medical personnel, as defined in paragraph (s) of this section, who 
are employed by or otherwise formally affiliated with the facility, 
acquire such information about a reportable event.
    (2) Manufacturers are considered to have become aware of an event 
when:
    (i) Any employee becomes aware of a reportable event that is 
required to be reported within 30 days or that is required to be 
reported within 5 days under a written request from FDA under 
Sec. 803.53(b); and
    (ii) Any employee, who is a person with management or supervisory 
responsibilities over persons with regulatory, scientific, or technical 
responsibilities, or a person whose duties relate to the collection and 
reporting of adverse events, becomes aware that a reportable MDR event 
or events, from

[[Page 40]]

any information, including any trend analysis, necessitate remedial 
action to prevent an unreasonable risk of substantial harm to the public 
health.
    (3) Importers are considered to have become aware of an event when 
any employee becomes aware of a reportable event that is required to be 
reported by an importer within 30 days.
    (d) Caused or contributed means that a death or serious injury was 
or may have been attributed to a medical device, or that a medical 
device was or may have been a factor in a death or serious injury, 
including events occurring as a result of:
    (1) Failure;
    (2) Malfunction;
    (3) Improper or inadequate design;
    (4) Manufacture;
    (5) Labeling; or
    (6) User error.
    (e)(1) Device family means a group of one or more devices 
manufactured by or for the same manufacturer and having the same:
    (i) Basic design and performance characteristics related to device 
safety and effectiveness,
    (ii) Intended use and function, and
    (iii) Device classification and product code.
    (2) Devices that differ only in minor ways not related to safety or 
effectiveness can be considered to be in the same device family. Factors 
such as brand name and common name of the device and whether the devices 
were introduced into commercial distribution under the same 510(k) or 
premarket approval application (PMA), may be considered in grouping 
products into device families.
    (f) Device user facility means a hospital, ambulatory surgical 
facility, nursing home, outpatient diagnostic facility, or outpatient 
treatment facility as defined in paragraphs (l), (b), (t), (u), and (v), 
respectively, of this section, which is not a ``physician's office,'' as 
defined in paragraph (w) of this section. School nurse offices and 
employee health units are not device user facilities.
    (g) Distributor means, for the purposes of this part, any person 
(other than the manufacturer or importer) who furthers the marketing of 
a device from the original place of manufacture to the person who makes 
final delivery or sale to the ultimate user, but who does not repackage 
or otherwise change the container, wrapper or labeling of the device or 
device package. One who repackages or otherwise changes the container, 
wrapper, or labeling, is a manufacturer under paragraph (o) of this 
section.
    (h) [Reserved]
    (i) Expected life of a device (required on the manufacturer's 
baseline report) means the time that a device is expected to remain 
functional after it is placed into use. Certain implanted devices have 
specified ``end of life'' (EOL) dates. Other devices are not labeled as 
to their respective EOL, but are expected to remain operational through 
maintenance, repair, upgrades, etc., for an estimated period of time.
    (j) FDA means the Food and Drug Administration.
    (k) Five-day report means a medical device report that must be 
submitted by a manufacturer to FDA pursuant to Sec. 803.53, on FDA Form 
3500A or electronic equivalent as approved under Sec. 803.14, within 5 
work days.
    (l) Hospital means a distinct entity that operates for the primary 
purpose of providing diagnostic, therapeutic (medical, occupational, 
speech, physical, etc.), surgical and other patient services for 
specific and general medical conditions. Hospitals include general, 
chronic disease, rehabilitative, psychiatric, and other special-purpose 
facilities. A hospital may be either independent (e.g., not a part of a 
provider of services or any other facility) or may be operated by 
another medical entity (e.g., under the common ownership, licensure or 
control of another entity). A hospital is covered by this regulation 
regardless of whether it is licensed by a Federal, State, municipal or 
local government or whether it is accredited by a recognized 
accreditation organization. If an adverse event meets the criteria for 
reporting, the hospital must report that event regardless of the nature 
or location of the medical service provided by the hospital.
    (m) Importer means, for the purposes of this part, any person who 
imports a device into the United States and who furthers the marketing 
of a device

[[Page 41]]

from the original place of manufacture to the person who makes final 
delivery or sale to the ultimate user, but who does not repackage or 
otherwise change the container, wrapper, or labeling of the device or 
device package. One who repackages or otherwise changes the container, 
wrapper, or labeling, is a manufacturer under paragraph (o) of this 
section.
    (n) Malfunction means the failure of a device to meet its 
performance specifications or otherwise perform as intended. Performance 
specifications include all claims made in the labeling for the device. 
The intended performance of a device refers to the intended use for 
which the device is labeled or marketed, as defined in Sec. 801.4 of 
this chapter.
    (o) Manufacturer means any person who manufactures, prepares, 
propagates, compounds, assembles, or processes a device by chemical, 
physical, biological, or other procedure. The term includes any person 
who:
    (1) Repackages or otherwise changes the container, wrapper or 
labeling of a device in furtherance of the distribution of the device 
from the original place of manufacture;
    (2) Initiates specifications for devices that are manufactured by a 
second party for subsequent distribution by the person initiating the 
specifications;
    (3) Manufactures components or accessories which are devices that 
are ready to be used and are intended to be commercially distributed and 
intended to be used as is, or are processed by a licensed practitioner 
or other qualified person to meet the needs of a particular patient; or
    (4) Is the U.S. agent of a foreign manufacturer.
    (p) Manufacturer or importer report number means the number that 
uniquely identifies each individual adverse event report submitted by a 
manufacturer or importer. This number consists of three parts as 
follows:
    (1) The FDA registration number for the manufacturing site of the 
reported device, or the registration number for the importer. (If the 
manufacturing site or the importer does not have a registration number, 
FDA will assign a temporary MDR reporting number until the site is 
officially registered. The manufacturer or importer will be informed of 
the temporary number.);
    (2) The four-digit calendar year in which the report is submitted; 
and
    (3) The five-digit sequence number of the reports submitted during 
the year, starting with 00001. (For example, the complete number will 
appear 1234567-1995-00001.)
    (q) MDR means medical device report.
    (r) MDR reportable event (or reportable event) means:
    (1) An event about which user facilities become aware of information 
that reasonably suggests that a device has or may have caused or 
contributed to a death or serious injury; or
    (2) An event about which manufacturers or importers have received or 
become aware of information that reasonably suggests that one of their 
marketed devices:
    (i) May have caused or contributed to a death or serious injury; or
    (ii) Has malfunctioned and that the device or a similar device 
marketed by the manufacturer or importer would be likely to cause a 
death or serious injury if the malfunction were to recur.
    (s) Medical personnel, as used in this part, means an individual 
who:
    (1) Is licensed, registered, or certified by a State, territory, or 
other governing body, to administer health care;
    (2) Has received a diploma or a degree in a professional or 
scientific discipline;
    (3) Is an employee responsible for receiving medical complaints or 
adverse event reports; or
    (4) Is a supervisor of such persons.
    (t)(1) Nursing home means an independent entity (i.e., not a part of 
a provider of services or any other facility) or one operated by another 
medical entity (e.g., under the common ownership, licensure, or control 
of an entity) that operates for the primary purpose of providing:
    (i) Skilled nursing care and related services for persons who 
require medical or nursing care;
    (ii) Hospice care to the terminally ill; or
    (iii) Services for the rehabilitation of the injured, disabled, or 
sick.

[[Page 42]]

    (2) A nursing home is subject to this regulation regardless of 
whether it is licensed by a Federal, State, municipal, or local 
government or whether it is accredited by a recognized accreditation 
organization. If an adverse event meets the criteria for reporting, the 
nursing home must report that event regardless of the nature, or 
location of the medical service provided by the nursing home.
    (u)(1) Outpatient diagnostic facility means a distinct entity that:
    (i) Operates for the primary purpose of conducting medical 
diagnostic tests on patients;
    (ii) Does not assume ongoing responsibility for patient care; and
    (iii) Provides its services for use by other medical personnel. 
(Examples include diagnostic radiography, mammography, ultrasonography, 
electrocardiography, magnetic resonance imaging, computerized axial 
tomography and in-vitro testing).
    (2) An outpatient diagnostic facility may be either independent 
(i.e., not a part of a provider of services or any other facility) or 
operated by another medical entity (e.g., under the common ownership, 
licensure, or control of an entity). An outpatient diagnostic facility 
is covered by this regulation regardless of whether it is licensed by a 
Federal, State, municipal, or local government or whether it is 
accredited by a recognized accreditation organization. If an adverse 
event meets the criteria for reporting, the outpatient diagnostic 
facility must report that event regardless of the nature or location of 
the medical service provided by the outpatient diagnostic facility.
    (v)(1) Outpatient treatment facility means a distinct entity that 
operates for the primary purpose of providing nonsurgical therapeutic 
(medical, occupational, or physical) care on an outpatient basis or home 
health care setting. Outpatient treatment facilities include ambulance 
providers, rescue services, and home health care groups. Examples of 
services provided by outpatient treatment facilities include: Cardiac 
defibrillation, chemotherapy, radiotherapy, pain control, dialysis, 
speech or physical therapy, and treatment for substance abuse.
    (2) An outpatient treatment facility may be either independent 
(i.e., not a part of a provider of services or any other facility) or 
operated by another medical entity (e.g., under the common ownership, 
licensure, or control of an entity). An outpatient treatment facility is 
covered by this regulation regardless of whether it is licensed by a 
Federal, State, municipal, or local government or whether it is 
accredited by a recognized accreditation organization. If an adverse 
event meets the criteria for reporting, the outpatient treatment 
facility must report that event regardless of the nature or location of 
the medical service provided by the outpatient treatment facility.
    (w) Patient of the facility means any individual who is being 
diagnosed or treated and/or receiving medical care at or under the 
control or authority of the facility. For the purposes of this part, the 
definition encompasses employees of the facility or individuals 
affiliated with the facility, who in the course of their duties suffer a 
device-related death or serious injury that has or may have been caused 
or contributed to by a device used at the facility.
    (x) Physician's office means a facility that operates as the office 
of a physician or other health care professional (e.g., dentist, 
chiropractor, optometrist, nurse practitioner, school nurse offices, 
school clinics, employee health clinics, or free-standing care units) 
for the primary purpose of examination, evaluation, and treatment or 
referral of patients. A physician's office may be independent, a group 
practice, or part of a Health Maintenance Organization.
    (y) [Reserved]
    (z) Remedial action means, for the purposes of this subpart, any 
action other than routine maintenance or servicing, of a device where 
such action is necessary to prevent recurrence of a reportable event.
    (aa) [Reserved]
    (bb)(1) Serious injury means an injury or illness that:
    (i) Is life-threatening;
    (ii) Results in permanent impairment of a body function or permanent 
damage to body structure; or
    (iii) Necessitates medical or surgical intervention to preclude 
permanent

[[Page 43]]

impairment of a body function or permanent damage to a body structure.
    (2) Permanent means, for purposes of this subpart, irreversible 
impairment or damage to a body structure or function, excluding trivial 
impairment or damage.
    (cc) Shelf life, as required on the manufacturer's baseline report, 
means the maximum time a device will remain functional from the date of 
manufacture until it is used in patient care. Some devices have an 
expiration date on their labeling indicating the maximum time they can 
be stored before losing their ability to perform their intended 
function.
    (dd) [Reserved]
    (ee)(1) User facility report number means the number that uniquely 
identifies each report submitted by a user facility to manufacturers and 
FDA. This number consists of three parts as follows:
    (i) The user facility's 10-digit Health Care Financing 
Administration (HCFA) number (if the HCFA number has fewer than 10 
digits, fill the remaining spaces with zeros);
    (ii) The four-digit calendar year in which the report is submitted; 
and
    (iii) The four-digit sequence number of the reports submitted for 
the year, starting with 0001. (For example, a complete number will 
appear as follows: 1234560000-1995-0001.)
    (2) If a facility has more than one HCFA number, it must select one 
that will be used for all of its MDR reports. If a facility has no HCFA 
number, it should use all zeros in the appropriate space in its initial 
report (e.g., 0000000000-1995-0001) and FDA will assign a number for 
future use. The number assigned will be used in FDA's record of that 
report and in any correspondence with the user facility. All zeros 
should be used subsequent to the first report if the user does not 
receive FDA's assigned number before the next report is submitted. If a 
facility has multiple sites, the primary site can report centrally and 
use one reporting number for all sites if the primary site provides the 
name, address and HCFA number for each respective site.
    (ee) Work day means Monday through Friday, excluding Federal 
holidays.

[60 FR 63597, Dec. 11, 1995, as amended at 65 FR 4118, Jan. 26, 2000]

    Effective Date Note: At 61 FR 38347, July 23, 1996, in Sec. 803.3, 
paragraph (n)(4) was stayed indefinitely.



Sec. 803.9  Public availability of reports.

    (a) Any report, including any FDA record of a telephone report, 
submitted under this part is available for public disclosure in 
accordance with part 20 of this chapter.
    (b) Before public disclosure of a report, FDA will delete from the 
report:
    (1) Any information that constitutes trade secret or confidential 
commercial or financial information under Sec. 20.61 of this chapter;
    (2) Any personal, medical, and similar information (including the 
serial number of implanted devices), which would constitute an invasion 
of personal privacy under Sec. 20.63 of this chapter. FDA will disclose 
to a patient who requests a report, all the information in the report 
concerning that patient, as provided in Sec. 20.61 of this chapter; and
    (3) Any names and other identifying information of a third party 
voluntarily submitting an adverse event report.
    (c) FDA may not disclose the identity of a device user facility 
which makes a report under this part except in connection with:
    (1) An action brought to enforce section 301(q) of the act, 
including the failure or refusal to furnish material or information 
required by section 519 of the act;
    (2) A communication to a manufacturer of a device which is the 
subject of a report required by a user facility under Sec. 803.30; or
    (3) A disclosure to employees of the Department of Health and Human 
Services, to the Department of Justice, or to the duly authorized 
committees and subcommittees of the Congress.

[60 FR 63597, Dec. 11, 1995, as amended at 65 FR 4119, Jan. 26, 2000]

[[Page 44]]



Sec. 803.10  General description of reports required from user facilities, importers, and manufacturers.

    (a) Device user facilities. User facilities must submit the 
following reports, which are described more fully in subpart C of this 
part.
    (1) User facilities must submit MDR reports of individual adverse 
events within 10 days after the user facility becomes aware of an MDR 
reportable event as described in Secs. 803.30 and 803.32.
    (i) User facilities must submit reports of device-related deaths to 
FDA and to the manufacturer, if known.
    (ii) User facilities must submit reports of device-related serious 
injuries to manufacturers, or to FDA, if the manufacturer is unknown.
    (2) User facilities must submit annual reports as described in 
Sec. 803.33.
    (b) Importers must submit MDR reports of individual adverse events 
within 30 days after the importer becomes aware of an MDR reportable 
event as described in Sec. 803.3. Importers must submit reports of 
device-related deaths or serious injuries to FDA and to the manufacturer 
and reports of malfunctions to the manufacturer.
    (c) Device manufacturers. Manufacturers must submit the following 
reports as described more fully in subpart E of this part:
    (1) MDR reports of individual adverse events within 30 days after 
the manufacturer becomes aware of a reportable death, serious injury, or 
malfunction as described in Secs. 803.50 and 803.52.
    (2) MDR reports of individual adverse events within 5 days of:
    (i) Becoming aware that a reportable MDR event requires remedial 
action to prevent an unreasonable risk of substantial harm to the public 
health or,
    (ii) Becoming aware of an MDR reportable event for which FDA has 
made a written request, as described in Sec. 803.53.
    (3) Annual baseline reports as described in Sec. 803.55.
    (4) Supplemental reports if they obtain information that was not 
provided in an initial report as described in Sec. 803.56.
    (5) Annual certification to FDA of the number of MDR reports filed 
during the preceding year as described in Sec. 803.57.

[60 FR 63597, Dec. 11, 1995, as amended at 65 FR 4119, Jan. 26, 2000]



Sec. 803.11  Obtaining the forms.

    User facilities and manufacturers must submit all reports of 
individual adverse events on FDA Form 3500A (MEDWATCH form) or in an 
electronic equivalent as approved under Sec. 803.14. This form and all 
other forms referenced in this section can also be obtained from the 
Consolidated Forms and Publications Office, Washington Commerce Center, 
3222 Hubbard Rd., Landover, MD 20875; from the Food and Drug 
Administration, MEDWATCH (HF-2), 5600 Fishers Lane, Rockville, MD 20857, 
301-827-7240; from the Division of Small Manufacturers Assistance, 
Office of Health and Industry Programs, Center for Devices and 
Radiological Health (HFZ-220), 1350 Piccard Dr. Rockville, MD 20850, FAX 
301-443-8818; or from http://www.fda.gov/opacom/morechoices/fdaforms/
cdrh.html on the Internet.

[65 FR 17136, Mar. 31, 2000]



Sec. 803.12  Where to submit reports.

    (a) Any written report or additional information required under this 
part shall be submitted to: Food and Drug Administration, Center for 
Devices and Radiological Health, Medical Device Reporting, PO Box 3002, 
Rockville, MD 20847-3002.
    (b) Each report and its envelope shall be specifically identified, 
e.g., ``User Facility Report,'' ``Annual Report,'' ``Importer Report,'' 
``Manufacturer Report,'' ``5-Day Report,'' ``Baseline Report,'' etc.
    (c) If an entity is confronted with a public health emergency, this 
can be brought to FDA's attention by contacting the FDA Emergency 
Operations Branch (HFC-162), Office of Regional Operations, at 301-443-
1240, and should be followed by the submission of a FAX report to 301-
443-3757.

[[Page 45]]

    (d) A voluntary telephone report may be submitted to, or information 
regarding voluntary reporting may be obtained from, the MEDWATCH hotline 
at 800-FDA-1088.

[60 FR 63597, Dec. 11, 1995, as amended at 65 FR 4119, Jan. 26, 2000]



Sec. 803.13  English reporting requirement.

    (a) All reports required in this part which are submitted in writing 
or electronic equivalent shall be submitted to FDA in English.
    (b) All reports required in this part which are submitted on an 
electronic medium shall be submitted to FDA in a manner consistent with 
Sec. 803.14.



Sec. 803.14  Electronic reporting.

    (a) Any report required by this part may be submitted electronically 
with prior written consent from FDA. Such consent is revocable. 
Electronic report submissions include alternative reporting media 
(magnetic tape, disc, etc.) and computer-to-computer communication.
    (b) Any electronic report meeting electronic reporting standards, 
guidelines, or other procedures developed by the agency for MDR 
reporting will be deemed to have prior approval for use.



Sec. 803.15  Requests for additional information.

    (a) FDA may determine that protection of the public health requires 
additional or clarifying information for medical device reports 
submitted to FDA under this part. In these instances, and in cases when 
the additional information is beyond the scope of FDA reporting forms or 
is not readily accessible, the agency will notify the reporting entity 
in writing of the additional information that is required.
    (b) Any request under this section shall state the reason or purpose 
for which the information is being requested, specify the date that the 
information is to be submitted and clearly relate the request to a 
reported event. All verbal requests will be confirmed in writing by the 
agency.



Sec. 803.16  Disclaimers.

    A report or other information submitted by a reporting entity under 
this part, and any release by FDA of that report or information, does 
not necessarily reflect a conclusion by the party submitting the report 
or by FDA that the report or information constitutes an admission that 
the device, or the reporting entity or its employees, caused or 
contributed to the reportable event. The reporting entity need not admit 
and may deny that the report or information submitted under this part 
constitutes an admission that the device, the party submitting the 
report, or employees thereof, caused or contributed to a reportable 
event.



Sec. 803.17  Written MDR procedures.

    User facilities, importers, and manufacturers shall develop, 
maintain, and implement written MDR procedures for the following:
    (a) Internal systems that provide for:
    (1) Timely and effective identification, communication, and 
evaluation of events that may be subject to medical device reporting 
requirements;
    (2) A standardized review process/procedure for determining when an 
event meets the criteria for reporting under this part; and
    (3) Timely transmission of complete medical device reports to FDA 
and/or manufacturers;
    (b) Documentation and recordkeeping requirements for:
    (1) Information that was evaluated to determine if an event was 
reportable;
    (2) All medical device reports and information submitted to FDA and 
manufacturers;
    (3) Any information that was evaluated for the purpose of preparing 
the submission of semiannual reports or certification; and
    (4) Systems that ensure access to information that facilitates 
timely followup and inspection by FDA.

[60 FR 63597, Dec. 11, 1995, as amended at 65 FR 4119, Jan. 26, 2000]



Sec. 803.18  Files and distributor records.

    (a) User facilities, importers, and manufacturers shall establish 
and maintain MDR event files. All MDR

[[Page 46]]

event files shall be prominently identified as such and filed to 
facilitate timely access.
    (b)(1) For purposes of this part, ``MDR event files'' are written or 
electronic files maintained by user facilities, importers, and 
manufacturers. MDR event files may incorporate references to other 
information, e.g., medical records, patient files, engineering reports, 
etc., in lieu of copying and maintaining duplicates in this file. MDR 
event files must contain:
    (i) Information in the possession of the reporting entity or 
references to information related to the adverse event, including all 
documentation of the entity's deliberations and decisionmaking processes 
used to determine if a device-related death, serious injury, or 
malfunction was or was not reportable under this part.
    (ii) Copies of all MDR forms, as required by this part, and other 
information related to the event that was submitted to FDA and other 
entities (e.g., an importer, distributor, or manufacturer).
    (2) User facilities, importers, and manufacturers shall permit any 
authorized FDA employee during all reasonable times to access, to copy, 
and to verify the records required by this part.
    (c) User facilities shall retain an MDR event file relating to an 
adverse event for a period of 2 years from the date of the event. 
Manufacturers and importers shall retain an MDR event file relating to 
an adverse event for a period of 2 years from the date of the event or a 
period of time equivalent to the expected life of the device, whichever 
is greater. MDR event files must be maintained for the time periods 
described in this paragraph even if the device is no longer distributed.
    (d)(1) A device distributor shall establish and maintain device 
complaint records containing any incident information, including any 
written, electronic, or oral communication, either received by or 
generated by the firm, that alleges deficiencies related to the identity 
(e.g., labeling), quality, durability, reliability, safety, 
effectiveness, or performance of a device. Information regarding the 
evaluation of the allegations, if any, shall also be maintained in the 
incident record. Device incident records shall be prominently identified 
as such and shall be filed by device, and may be maintained in written 
or electronic form. Files maintained in electronic form must be backed 
up.
    (2) A device distributor shall retain copies of the records required 
to be maintained under this section for a period of 2 years from the 
date of inclusion of the record in the file or for a period of time 
equivalent to the expected life of the device, whichever is greater, 
even if the distributor has ceased to distribute the device that is the 
subject of the record.
    (3) A device distributor shall maintain the device complaint files 
established under this section at the distributor's principal business 
establishment. A distributor that is also a manufacturer may maintain 
the file at the same location as the manufacturer maintains its 
complaint file under Secs. 820.180 and 820.198 of this chapter. A device 
distributor shall permit any authorized FDA employee, during all 
reasonable times, to have access to, and to copy and verify, the records 
required by this part.
    (e) The manufacturer may maintain MDR event files as part of its 
complaint file, under Sec. 820.198 of this chapter, provided that such 
records are prominently identified as MDR reportable events. A report 
submitted under this subpart A shall not be considered to comply with 
this part unless the event has been evaluated in accordance with the 
requirements of Secs. 820.162 and 820.198 of this chapter. MDR files 
shall contain an explanation of why any information required by this 
part was not submitted or could not be obtained. The results of the 
evaluation of each event are to be documented and maintained in the 
manufacturer's MDR event file.

[60 FR 63597, Dec. 11, 1995, as amended at 65 FR 4119, Jan. 26, 2000]



Sec. 803.19  Exemptions, variances, and alternative reporting requirements.

    (a) The following persons are exempt from the reporting requirements 
under this part.

[[Page 47]]

    (1) An individual who is a licensed practitioner who prescribes or 
administers devices intended for use in humans and who manufactures or 
imports devices solely for use in diagnosing and treating persons with 
whom the practitioner has a ``physician-patient'' relationship.
    (2) An individual who manufactures devices intended for use in 
humans solely for such person's use in research or teaching and not for 
sale, including any person who is subject to alternative reporting 
requirements under the investigational device exemption regulations, 
parts 812 and 813 of this chapter, which require reporting of all 
adverse device effects.
    (3) Dental laboratories, or optical laboratories.
    (b) Manufacturers, importers, or user facilities may request 
exemptions or variances from any or all of the reporting requirements in 
this part. The request shall be in writing and include information 
necessary to identify the firm and device, a complete statement of the 
request for exemption, variance, or alternative reporting, and an 
explanation why the request is justified.
    (c) FDA may grant in writing, to a manufacturer, importer, or user 
facility, an exemption, variance, or alternative from, or to, any or all 
of the reporting requirements in this part and may change the frequency 
of reporting to quarterly, semiannually, annually, or other appropriate 
time period. These modifications may be initiated by a request as 
specified in this section, or at the discretion of FDA. When granting 
such modifications, FDA may impose other reporting requirements to 
ensure the protection of public health.
    (d) FDA may revoke or modify in writing an exemption, variance, or 
alternative reporting requirements if FDA determines that protection of 
the public health justifies the modification or a return to the 
requirements as stated in this part.
    (e) Firms granted a reporting modification by FDA shall provide any 
reports or information required by that approval. The conditions of the 
approval will replace and supersede the reporting requirement specified 
in this part until such time that FDA revokes or modifies the 
alternative reporting requirements in accordance with paragraph (d) of 
this section.

[60 FR 63597, Dec. 11, 1995, as amended at 61 FR 44615, Aug. 28, 1996; 
65 FR 4119, Jan. 26, 2000; 65 FR 17136, Mar. 31, 2000]



  Subpart B--Generally Applicable Requirements for Individual Adverse 
                              Event Reports



Sec. 803.20  How to report.

    (a) Description of form. There are two versions of the MEDWATCH form 
for individual reports of adverse events. FDA Form 3500 is available for 
use by health professionals and consumers for the submission of 
voluntary reports regarding FDA-regulated products. FDA Form 3500A is 
the mandatory reporting form to be used for submitting reports by user 
facilities and manufacturers of FDA-regulated products. The form has 
sections that must be completed by all reporters and other sections that 
must be completed only by the user facility, importer, or manufacturer.
    (1) The front of FDA Form 3500A is to be filled out by all 
reporters. The front of the form requests information regarding the 
patient, the event, the device, and the ``initial reporter'' (i.e., the 
first person or entity that submitted the information to the user 
facility, manufacturer, or importer).
    (2) The back part of the form contains sections to be completed by 
user facilities, importers, and manufacturers. User facilities must 
complete section F; device manufacturers must complete sections G and H. 
Manufacturers are not required to recopy information submitted to them 
on a Form 3500A unless the information is being copied onto an 
electronic medium. If the manufacturer corrects or supplies information 
missing from the other reporter's 3500A form, it should attach a copy of 
that form to the manufacturer's report form. If the information from the 
other reporter's 3500A form is complete and correct, the manufacturer 
can fill in the remaining information on the same form.
    (b) Reporting standards. (1) User facilities are required to submit 
MDR reports to:
    (i) The device manufacturer and to FDA within 10 days of becoming 
aware

[[Page 48]]

of information that reasonably suggests that a device has or may have 
caused or contributed to a death; or
    (ii) The manufacturer within 10 days of becoming aware of 
information that reasonably suggests that a device has or may have 
caused or contributed to a serious injury. Such reports shall be 
submitted to FDA if the device manufacturer is not known.
    (2) Importers are required to submit death and serious injury 
reports to FDA and the device manufacturer and submit malfunction 
reports to the manufacturer only:
    (i) Within 30 days of becoming aware of information that reasonably 
suggests that a device has or may have caused or contributed to a death 
or serious injury.
    (ii) Within 30 days of receiving information that a device marketed 
by the importer has malfunctioned and that such a device or a similar 
device marketed by the importer would be likely to cause or contribute 
to a death or serious injury if the malfunction were to recur.
    (3) Manufacturers are required to submit MDR reports to FDA:
    (i) Within 30 days of becoming aware of information that reasonably 
suggests that a device may have caused or contributed to a death or 
serious injury; or
    (ii) Within 30 days of becoming aware of information that reasonably 
suggests a device has malfunctioned and that device or a similar device 
marketed by the manufacturer would be likely to cause a death or serious 
injury if the malfunction were to recur; or
    (iii) Within 5 days if required by Sec. 803.53.
    (c) Information that reasonably suggests a reportable event 
occurred. (1) Information that reasonably suggests that a device has or 
may have caused or contributed to an MDR reportable event (i.e., death, 
serious injury, and, for manufacturers, a malfunction that would be 
likely to cause or contribute to a death or serious injury if the 
malfunction were to recur) includes any information, such as 
professional, scientific or medical facts and observations or opinions, 
that would reasonably suggest that a device has caused or may have 
caused or contributed to a reportable event.
    (2) Entities required to report under this part do not have to 
report adverse events for which there is information that would cause a 
person who is qualified to make a medical judgment (e.g., a physician, 
nurse, risk manager, or biomedical engineer) to reach a reasonable 
conclusion that a device did not cause or contribute to a death or 
serious injury, or that a malfunction would not be likely to cause or 
contribute to a death or serious injury if it were to recur. Information 
which leads the qualified person to determine that a device-related 
event is or is not reportable must be contained in the MDR event files, 
as described in Sec. 803.18.

[60 FR 63597, Dec. 11, 1995, as amended at 65 FR 4119, Jan. 26, 2000]



Sec. 803.21  Reporting codes.

    (a) FDA has developed a MEDWATCH Mandatory Reporting Form Coding 
Manual for use with medical device reports. This manual contains codes 
for hundreds of adverse events for use with FDA Form 3500A. The coding 
manual is available from the Division of Small Manufacturer Assistance, 
Center for Devices and Radiological Health, 1350 Piccard Dr., Rockville, 
MD 20850, FAX 301-443-8818.
    (b) FDA may use additional coding of information on the reporting 
forms or modify the existing codes on an ad hoc or generic basis. In 
such cases, FDA will ensure that the new coding information is available 
to all reporters.



Sec. 803.22  When not to file.

    (a) Only one medical device report from the user facility, importer, 
or manufacturer is required under this part if the reporting entity 
becomes aware of information from multiple sources regarding the same 
patient and same event.
    (b) A medical device report that would otherwise be required under 
this section is not required if:
    (1) The user facility, importer, or manufacturer determines that the 
information received is erroneous in that a device-related adverse event 
did not occur. Documentation of such reports shall be retained in MDR 
files for time periods specified in Sec. 803.18.

[[Page 49]]

    (2) The manufacturer or importer determines that the device was 
manufactured or imported by another manufacturer or importer. Any 
reportable event information that is erroneously sent to a manufacturer 
or importer shall be forwarded to FDA, with a cover letter explaining 
that the device in question was not manufactured or imported by that 
firm.

[60 FR 63597, Dec. 11, 1995, as amended at 65 FR 4120, Jan. 26, 2000]



             Subpart C--User Facility Reporting Requirements



Sec. 803.30  Individual adverse event reports; user facilities.

    (a) Reporting standard. A user facility shall submit the following 
reports to the manufacturer or to FDA, or both, as specified below:
    (1) Reports of death. Whenever a user facility receives or otherwise 
becomes aware of information, from any source, that reasonably suggests 
that a device has or may have caused or contributed to the death of a 
patient of the facility, the facility shall as soon as practicable, but 
not later than 10 work days after becoming aware of the information, 
report the information required by Sec. 803.32 to FDA, on FDA Form 
3500A, or an electronic equivalent as approved under Sec. 803.14, and if 
the identity of the manufacturer is known, to the device manufacturer.
    (2) Reports of serious injury. Whenever a user facility receives or 
otherwise becomes aware of information, from any source, that reasonably 
suggests that a device has or may have caused or contributed to a 
serious injury to a patient of the facility, the facility shall, as soon 
as practicable but not later than 10 work days after becoming aware of 
the information, report the information required by Sec. 803.32, on FDA 
Form 3500A or electronic equivalent, as approved under Sec. 803.14, to 
the manufacturer of the device. If the identity of the manufacturer is 
not known, the report shall be submitted to FDA.
    (b) Information that is reasonably known to user facilities. User 
facilities must provide all information required in this subpart C that 
is reasonably known to them. Such information includes information found 
in documents in the possession of the user facility and any information 
that becomes available as a result of reasonable followup within the 
facility. A user facility is not required to evaluate or investigate the 
event by obtaining or evaluating information that is not reasonably 
known to it.



Sec. 803.32  Individual adverse event report data elements.

    User facility reports shall contain the following information, 
reasonably known to them as described in 803.30(b), which corresponds to 
the format of FDA Form 3500A:
    (a) Patient information (Block A) shall contain the following:
    (1) Patient name or other identifier;
    (2) Patient age at the time of event, or date of birth;
    (3) Patient gender; and
    (4) Patient weight.
    (b) Adverse event or product problem (Block B) shall contain the 
following:
    (1) Identification of adverse event or product problem;
    (2) Outcomes attributed to the adverse event, e.g., death; or 
serious injury, that is:
    (i) Life threatening injury or illness;
    (ii) Disability resulting in permanent impairment of a body function 
or permanent damage to a body structure; or
    (iii) Injury or illness that requires intervention to prevent 
permanent impairment of a body structure or function;
    (3) Date of event;
    (4) Date of report by the initial reporter;
    (5) Description of event or problem, including a discussion of how 
the device was involved, nature of the problem, patient followup or 
required treatment, and any environmental conditions that may have 
influenced the event;
    (6) Description of relevant tests including dates and laboratory 
data; and
    (7) Description of other relevant history including pre- existing 
medical conditions.
    (c) Device information (Block D) shall contain the following:
    (1) Brand name;
    (2) Type of device;
    (3) Manufacturer name and address;

[[Page 50]]

    (4) Operator of the device (health professional, patient, lay user, 
other);
    (5) Expiration date;
    (6) Model number, catalog number, serial number, lot number, or 
other identifying number;
    (7) Date of device implantation (month, day, year);
    (8) Date of device explantation (month, day, year);
    (9) Whether device was available for evaluation and whether device 
was returned to the manufacturer; if so, the date it was returned to the 
manufacturer; and
    (10) Concomitant medical products and therapy dates. (Do not list 
products that were used to treat the event.)
    (d) Initial reporter information (Block E) shall contain the 
following:
    (1) Name, address, and telephone number of the reporter who 
initially provided information to the user facility, manufacturer, or 
distributor;
    (2) Whether the initial reporter is a health professional;
    (3) Occupation; and
    (4) Whether initial reporter also sent a copy of the report to FDA, 
if known.
    (e) User facility information (Block F) shall contain the following:
    (1) Whether reporter is a user facility;
    (2) User facility number;
    (3) User facility address;
    (4) Contact person;
    (5) Contact person's telephone number;
    (6) Date the user facility became aware of the event (month, day, 
year);
    (7) Type of report (initial or followup (if followup, include report 
number of initial report));
    (8) Date of the user facility report (month, day, year);
    (9) Approximate age of device;
    (10) Event problem codes--patient code and device code (refer to FDA 
``Coding Manual For Form 3500A'');
    (11) Whether a report was sent to FDA and the date it was sent 
(month, day, year);
    (12) Location, where event occurred;
    (13) Whether report was sent to the manufacturer and the date it was 
sent (month, day, year); and
    (14) Manufacturer name and address; if available.



Sec. 803.33  Annual reports.

    (a) Each user facility shall submit to FDA an annual report on FDA 
Form 3419, or electronic equivalent as approved by FDA under 
Sec. 803.14. Annual reports shall be submitted by January 1 of each 
year. The annual report and envelope shall be clearly identified and 
submitted to FDA with information that includes:
    (1) User facility's HCFA provider number used for medical device 
reports, or number assigned by FDA for reporting purposes in accordance 
with Sec. 803.3(ee);
    (2) Reporting year;
    (3) Facility's name and complete address;
    (4) Total number of reports attached or summarized;
    (5) Date of the annual report and the lowest and highest user 
facility report number of medical device reports submitted during the 
report period, e.g., 1234567890-1995-0001 through 1000;
    (6) Name, position title, and complete address of the individual 
designated as the facility contact person responsible for reporting to 
FDA and whether that person is a new contact for that facility; and
    (7) Information for each reportable event that occurred during the 
annual reporting period including:
    (i) User facility report number;
    (ii) Name and address of the device manufacturer;
    (iii) Device brand name and common name;
    (iv) Product model, catalog, serial and lot number;
    (v) A brief description of the event reported to the manufacturer 
and/or FDA; and
    (vi) Where the report was submitted, i.e., to FDA, manufacturer, 
distributor, importer, etc.
    (b) In lieu of submitting the information in paragraph (a)(7) of 
this section, a user facility may submit a copy of FDA Form 3500A, or an 
electronic equivalent as approved under section 803.14, for each medical 
device report submitted to FDA and/or manufacturers by that facility 
during the reporting period.
    (c) If no reports are submitted to either FDA or manufacturers 
during

[[Page 51]]

these time periods, no annual report is required.

[60 FR 63597, Dec. 11, 1995, as amended at 65 FR 4120, Jan. 26, 2000]



               Subpart D--Importer Reporting Requirements

    Source: 65 FR 4120, Jan. 26, 2000, unless otherwise noted.



Sec. 803.40  Individual adverse event reporting requirements; importers.

    (a) An importer shall submit to FDA a report, and a copy of such 
report to the manufacturer, containing the information required by 
Sec. 803.42 on FDA form 3500A as soon as practicable, but not later than 
30 days after the importer receives or otherwise becomes aware of 
information from any source, including user facilities, individuals, or 
medical or scientific literature, whether published or unpublished, that 
reasonably suggests that one of its marketed devices may have caused or 
contributed to a death or serious injury.
    (b) An importer shall submit to the manufacturer a report containing 
information required by Sec. 803.42 on FDA form 3500A, as soon as 
practicable, but not later than 30 days after the importer receives or 
otherwise becomes aware of information from any source, including user 
facilities, individuals, or through the importer's own research, 
testing, evaluation, servicing, or maintenance of one of its devices, 
that one of the devices marketed by the importer has malfunctioned and 
that such device or a similar device marketed by the importer would be 
likely to cause or contribute to a death or serious injury if the 
malfunction were to recur.



Sec. 803.42  Individual adverse event report data elements.

    Individual medical device importer reports shall contain the 
following information, in so far as the information is known or should 
be known to the importer, as described in Sec. 803.40, which corresponds 
to the format of FDA Form 3500A:
    (a) Patient information (Block A) shall contain the following:
    (1) Patient name or other identifier;
    (2) Patient age at the time of event, or date of birth;
    (3) Patient gender; and
    (4) Patient weight.
    (b) Adverse event or product problem (Block B) shall contain the 
following:
    (1) Adverse event or product problem;
    (2) Outcomes attributed to the adverse event, that is:
    (i) Death;
    (ii) Life threatening injury or illness;
    (iii) Disability resulting in permanent impairment of a body 
function or permanent damage to a body structure; or
    (iv) Injury or illness that requires intervention to prevent 
permanent impairment of a body structure or function;
    (3) Date of event;
    (4) Date of report by the initial reporter;
    (5) Description of the event or problem to include a discussion of 
how the device was involved, nature of the problem, patient followup or 
required treatment, and any environmental conditions that may have 
influenced the event;
    (6) Description of relevant tests, including dates and laboratory 
data; and
    (7) Other relevant patient history including preexisting medical 
conditions.
    (c) Device information (Block D) shall contain the following:
    (1) Brand name;
    (2) Type of device;
    (3) Manufacturer name and address;
    (4) Operator of the device (health professional, patient, lay user, 
other);
    (5) Expiration date;
    (6) Model number, catalog number, serial number, lot number or other 
identifying number;
    (7) Date of device implantation (month, day, year);
    (8) Date of device explantation (month, day, year);
    (9) Whether the device was available for evaluation, and whether the 
device was returned to the manufacturer, and if so, the date it was 
returned to the manufacturer; and
    (10) Concomitant medical products and therapy dates. (Do not list 
products that were used to treat the event.)
    (d) Initial reporter information (Block E) shall contain the 
following:

[[Page 52]]

    (1) Name, address, and phone number of the reporter who initially 
provided information to the user facility, manufacturer, or distributor;
    (2) Whether the initial reporter is a health professional;
    (3) Occupation; and
    (4) Whether the initial reporter also sent a copy of the report to 
FDA, if known.
    (e) Importer information (Block F) shall contain the following:
    (1) Whether reporter is an importer;
    (2) Importer report number;
    (3) Importer address;
    (4) Contact person;
    (5) Contact person's telephone number;
    (6) Date the importer became aware of the event (month, day, year);
    (7) Type of report (initial or followup (if followup, include report 
number of initial report));
    (8) Date of the importer report (month, day, year);
    (9) Approximate age of device;
    (10) Event problem codes--patient code and device code (refer to FDA 
``Coding Manual For Form 3500A'');
    (11) Whether a report was sent to FDA and the date it was sent 
(month, day, year);
    (12) Location, where event occurred;
    (13) Whether a report was sent to the manufacturer and the date it 
was sent (month, day, year); and
    (14) Manufacturer name and address; if available.



             Subpart E--Manufacturer Reporting Requirements



Sec. 803.50  Individual adverse event reports; manufacturers.

    (a) Reporting standards. Device manufacturers are required to report 
within 30 days whenever the manufacturer receives or otherwise becomes 
aware of information, from any source, that reasonably suggests that a 
device marketed by the manufacturer:
    (1) May have caused or contributed to a death or serious injury; or
    (2) Has malfunctioned and such device or similar device marketed by 
the manufacturer would be likely to cause or contribute to a death or 
serious injury, if the malfunction were to recur.
    (b) Information that is reasonably known to manufacturers. (1) 
Manufacturers must provide all information required in this subpart E 
that is reasonably known to them. FDA considers the following 
information to be reasonably known to the manufacturer:
    (i) Any information that can be obtained by contacting a user 
facility, distributor and/or other initial reporter;
    (ii) Any information in a manufacturer's possession; or
    (iii) Any information that can be obtained by analysis, testing or 
other evaluation of the device.
    (2) Manufacturers are responsible for obtaining and providing FDA 
with information that is incomplete or missing from reports submitted by 
user facilities, distributors, and other initial reporters. 
Manufacturers are also responsible for conducting an investigation of 
each event, and evaluating the cause of the event. If a manufacturer 
cannot provide complete information on an MDR report, it must provide a 
statement explaining why such information was incomplete and the steps 
taken to obtain the information. Any required information not available 
at the time of the report, which is obtained after the initial filing, 
must be provided by the manufacturer in a supplemental report under 
Sec. 803.56.



Sec. 803.52  Individual adverse event report data elements.

    Individual medical device manufacturer reports shall contain the 
following information, known or reasonably known to them as described in 
Sec. 803.50(b), which corresponds to the format of FDA Form 3500A:
    (a) Patient information (Block A) shall contain the following:
    (1) Patient name or other identifier;
    (2) Patient age at the time of event, or date of birth;
    (3) Patient gender; and
    (4) Patient weight.
    (b) Adverse event or product problem (Block B) shall contain the 
following:
    (1) Adverse event or product problem;
    (2) Outcomes attributed to the adverse event, e.g., death; or 
serious injury, that is:
    (i) Life threatening injury or illness;

[[Page 53]]

    (ii) Disability resulting in permanent impairment of a body function 
or permanent damage to a body structure; or
    (iii) Injury or illness that requires intervention to prevent 
permanent impairment of a body structure or function;
    (3) Date of event;
    (4) Date of report by the initial reporter;
    (5) Description of the event or problem to include a discussion of 
how the device was involved, nature of the problem, patient followup or 
required treatment, and any environmental conditions that may have 
influenced the event;
    (6) Description of relevant tests, including dates and laboratory 
data; and
    (7) Other relevant patient history including pre-existing medical 
conditions.
    (c) Device information (Block D) shall contain the following:
    (1) Brand name;
    (2) Type of device;
    (3) Manufacturer name and address;
    (4) Operator of the device (health professional, patient, lay user, 
other);
    (5) Expiration date;
    (6) Model number, catalog number, serial number, lot number or other 
identifying number;
    (7) Date of device implantation (month, day, year);
    (8) Date of device explantation (month, day, year);
    (9) Whether the device was available for evaluation, and whether the 
device was returned to the manufacturer, and if so, the date it was 
returned to the manufacturer; and
    (10) Concomitant medical products and therapy dates. (Do not list 
products that were used to treat the event.)
    (d) Initial reporter information (Block E) shall contain the 
following:
    (1) Name, address, and phone number of the reporter who initially 
provided information to the user facility, manufacturer, or distributor;
    (2) Whether the initial reporter is a health professional;
    (3) Occupation; and
    (4) Whether the initial reporter also sent a copy of the report to 
FDA, if known.
    (e) All manufacturers (Block G) shall contain the following:
    (1) Contact office name and address and device manufacturing site;
    (2) Telephone number;
    (3) Report sources;
    (4) Date received by manufacturer (month, day, year);
    (5) Type of report being submitted (e.g., 5-day, initial, 
supplemental); and
    (6) Manufacturer report number.
    (f) Device manufacturers (Block H) shall contain the following:
    (1) Type of reportable event (death, serious injury, malfunction, 
etc.);
    (2) Type of followup report, if applicable (e.g., correction, 
response to FDA request, etc.);
    (3) If the device was returned to the manufacturer and evaluated by 
the manufacturer, a summary of the evaluation. If no evaluation was 
performed, provide an explanation why no evaluation was performed;
    (4) Device manufacture date (month, day, year);
    (5) Was device labeled for single use;
    (6) Evaluation codes (including event codes, method of evaluation, 
result, and conclusion codes) (refer to FDA ``Coding Manual for Form 
3500A'');
    (7) Whether remedial action was taken and type;
    (8) Whether use of device was initial, reuse, or unknown;
    (9) Whether remedial action was reported as a removal or correction 
under section 519(f) of the act (list the correction/removal report 
number); and
    (10) Additional manufacturer narrative; and/or
    (11) Corrected data, including:
    (i) Any information missing on the user facility report or 
distributor report, including missing event codes, or information 
corrected on such forms after manufacturer verification;
    (ii) For each event code provided by the user facility under 
Sec. 803.32(d)(10) or a distributor, a statement of whether the type of 
the event represented by the code is addressed in the device labeling; 
and
    (iii) If any required information was not provided, an explanation 
of why such information was not provided and the steps taken to obtain 
such information.

[[Page 54]]



Sec. 803.53  Five-day reports.

    A manufacturer shall submit a 5-day report to FDA, on Form 3500A or 
electronic equivalent as approved by FDA under Sec. 803.14 within 5 
workdays of:
    (a) Becoming aware that a reportable MDR event or events, from any 
information, including any trend analysis, necessitates remedial action 
to prevent an unreasonable risk of substantial harm to the public 
health; or
    (b) Becoming aware of an MDR reportable event for which FDA has made 
a written request for the submission of a 5-day report. When such a 
request is made, the manufacturer shall submit, without further 
requests, a 5-day report for all subsequent events of the same nature 
that involve substantially similar devices for the time period specified 
in the written request. The time period stated in the original written 
request can be extended by FDA if it is in the interest of the public 
health.



Sec. 803.55  Baseline reports.

    (a) A manufacturer shall submit a baseline report on FDA Form 3417, 
or electronic equivalent as approved by FDA under Sec. 803.14 for a 
device when the device model is first reported under Sec. 803.50.
    (b) Each baseline report shall be updated annually, on the 
anniversary month of the initial submission, after the initial baseline 
report is submitted. Changes to baseline information shall be reported 
in the manner described in Sec. 803.56 (i.e., include only the new, 
changed, or corrected information in the appropriate portion(s) of the 
report form). Baseline reports shall contain the following:
    (1) Name, complete address, and registration number of the 
manufacturer's reporting site. If the reporting site is not registered, 
FDA will assign a temporary registration number until the reporting site 
officially registers. The manufacturer will be informed of the temporary 
registration number;
    (2) FDA registration number of each site where the device is 
manufactured;
    (3) Name, complete address, and telephone number of the individual 
who has been designated by the manufacturer as its MDR contact and date 
of the report. For foreign manufacturers, a confirmation that the 
individual submitting the report is the agent of the manufacturer 
designated under Sec. 803.58(a) is required;
    (4) Product identification, including device family, brand name, 
generic name, model number, catalog number, product code and any other 
product identification number or designation;
    (5) Identification of any device previously reported in a baseline 
report that is substantially similar (e.g., same device with a different 
model number, or same device except for cosmetic differences in color or 
shape) to the device being reported, including the identification of the 
previously reported device by model number, catalog number or other 
product identification, and the date of the baseline report for the 
previously reported device;
    (6) Basis for marketing, including 510(k) premarket notification 
number or PMA number, if applicable, and whether the device is currently 
the subject of an approved post-market study under section 522 of the 
act;
    (7) Date the device was initially marketed and, if applicable, the 
date on which the manufacturer ceased marketing the device;
    (8) Shelf life, if applicable, and expected life of the device;
    (9) The number of devices manufactured and distributed in the last 
12 months and, an estimate of the number of devices in current use; and
    (10) Brief description of any methods used to estimate the number of 
devices distributed and the method used to estimate the number of 
devices in current use. If this information was provided in a previous 
baseline report, in lieu of resubmitting the information, it may be 
referenced by providing the date and product identification for the 
previous baseline report.

    Effective Date Note: At 61 FR 39869, July 31, 1996, in Sec. 803.55, 
paragraphs (b)(9) and (10) were stayed indefinitely.



Sec. 803.56  Supplemental reports.

    When a manufacturer obtains information required under this part 
that was not provided because it was not known or was not available when 
the initial report was submitted, the manufacturer shall submit to FDA 
the supplemental information within 1 month

[[Page 55]]

following receipt of such information. In supplemental reports, the 
manufacturer shall:
    (a) Indicate on the form and the envelope, that the reporting form 
being submitted is a supplemental report. If the report being 
supplemented is an FDA Form 3500A report, the manufacturer must select, 
in Item H-2, the appropriate code for the type of supplemental 
information being submitted;
    (b) Provide the appropriate identification numbers of the report 
that will be updated with the supplemental information, e.g., original 
manufacturer report number and user facility report number, if 
applicable;
    (c) For reports that cross reference previous reports, include only 
the new, changed, or corrected information in the appropriate portion(s) 
of the respective form(s).



Sec. 803.58  Foreign manufacturers.

    (a) Every foreign manufacturer whose devices are distributed in the 
United States shall designate a U.S. agent to be responsible for 
reporting in accordance with Sec. 807.40 of this chapter. The U.S. 
designated agent accepts responsibility for the duties that such 
designation entails. Upon the effective date of this regulation, foreign 
manufacturers shall inform FDA, by letter, of the name and address of 
the U.S. agent designated under this section and Sec. 807.40 of this 
chapter, and shall update this information as necessary. Such updated 
information shall be submitted to FDA, within 5 days of a change in the 
designated agent information.
    (b) U.S.-designated agents of foreign manufacturers are required to:
    (1) Report to FDA in accordance with Secs. 803.50, 803.52, 803.53, 
803.55, and 803.56;
    (2) Conduct, or obtain from the foreign manufacturer the necessary 
information regarding, the investigation and evaluation of the event to 
comport with the requirements of Sec. 803.50;
    (3) Certify in accordance with Sec. 803.57;
    (4) Forward MDR complaints to the foreign manufacturer and maintain 
documentation of this requirement;
    (5) Maintain complaint files in accordance with Sec. 803.18; and
    (6) Register, list, and submit premarket notifications in accordance 
with part 807 of this chapter.

    Effective Date Note: At 61 FR 38347, July 23, 1996, Sec. 803.58 was 
stayed indefinitely.



PART 806--MEDICAL DEVICES; REPORTS OF CORRECTIONS AND REMOVALS--Table of Contents




                      Subpart A--General Provisions

Sec.
806.1  Scope.
806.2  Definitions.

                     Subpart B--Reports and Records

806.10  Reports of corrections and removals.
806.20  Records of corrections and removals not required to be reported.
806.30  FDA access to records.
806.40  Public availability of reports.

    Authority: 21 U.S.C. 352, 360, 360i, 360j, 371, 374.

    Source: 62 FR 27191, May 19, 1997, unless otherwise noted.



                      Subpart A--General Provisions



Sec. 806.1  Scope.

    (a) This part implements the provisions of section 519(f) of the 
Federal Food, Drug, and Cosmetic Act (the act) requiring device 
manufacturers and importers to report promptly to the Food and Drug 
Administration (FDA) certain actions concerning device corrections and 
removals, and to maintain records of all corrections and removals 
regardless of whether such corrections and removals are required to be 
reported to FDA.
    (b) The following actions are exempt from the reporting requirements 
of this part:
    (1) Actions taken by device manufacturers or importers to improve 
the performance or quality of a device but that do not reduce a risk to 
health posed by the device or remedy a violation of the act caused by 
the device.
    (2) Market withdrawals as defined in Sec. 806.2(h).
    (3) Routine servicing as defined in Sec. 806.2(k).

[[Page 56]]

    (4) Stock recoveries as defined in Sec. 806.2(l).

[62 FR 27191, May 19, 1997, as amended at 63 FR 42232, Aug. 7, 1998]



Sec. 806.2  Definitions.

    As used in this part:
    (a) Act means the Federal Food, Drug, and Cosmetic Act.
    (b) Agency or FDA means the Food and Drug Administration.
    (c) Consignee means any person or firm that has received, purchased, 
or used a device subject to correction or removal.
    (d) Correction means the repair, modification, adjustment, 
relabeling, destruction, or inspection (including patient monitoring) of 
a device without its physical removal from its point of use to some 
other location.
    (e) Correction or removal report number means the number that 
uniquely identifies each report submitted.
    (f) Importer means, for the purposes of this part, any person who 
imports a device into the United States.
    (g) Manufacturer means any person who manufactures, prepares, 
propagates, compounds, assembles, or processes a device by chemical, 
physical, biological, or other procedures. The term includes any person 
who:
    (1) Repackages or otherwise changes the container, wrapper, or 
labeling of a device in furtherance of the distribution of the device 
from the original place of manufacture to the person who makes final 
delivery or sale to the ultimate user or consumer;
    (2) Initiates specifications for devices that are manufactured by a 
second party for subsequent distribution by the person initiating the 
specifications; or
    (3) Manufactures components or accessories which are devices that 
are ready to be used and are intended to be commercially distributed and 
are intended to be used as is, or are processed by a licensed 
practitioner or other qualified person to meet the needs of a particular 
patient.
    (h) Market withdrawal means a correction or removal of a distributed 
device that involves a minor violation of the act that would not be 
subject to legal action by FDA or that involves no violation of the act, 
e.g., normal stock rotation practices.
    (i) Removal means the physical removal of a device from its point of 
use to some other location for repair, modification, adjustment, 
relabeling, destruction, or inspection.
    (j) Risk to health means
    (1) A reasonable probability that use of, or exposure to, the 
product will cause serious adverse health consequences or death; or
    (2) That use of, or exposure to, the product may cause temporary or 
medically reversible adverse health consequences, or an outcome where 
the probability of serious adverse health consequences is remote.
    (k) Routine servicing means any regularly scheduled maintenance of a 
device, including the replacement of parts at the end of their normal 
life expectancy, e.g., calibration, replacement of batteries, and 
responses to normal wear and tear. Repairs of an unexpected nature, 
replacement of parts earlier than their normal life expectancy, or 
identical repairs or replacements of multiple units of a device are not 
routine servicing.
    (l) Stock recovery means the correction or removal of a device that 
has not been marketed or that has not left the direct control of the 
manufacturer, i.e., the device is located on the premises owned, or 
under the control of, the manufacturer, and no portion of the lot, 
model, code, or other relevant unit involved in the corrective or 
removal action has been released for sale or use.

[62 FR 27191, May 19, 1997, as amended at 63 FR 42232, Aug. 7, 1998]



                     Subpart B--Reports and Records



Sec. 806.10  Reports of corrections and removals.

    (a) Each device manufacturer or importer shall submit a written 
report to FDA of any correction or removal of a device initiated by such 
manufacturer or importer if the correction or removal was initiated:
    (1) To reduce a risk to health posed by the device; or
    (2) To remedy a violation of the act caused by the device which may 
present a risk to health unless the information has already been 
provided as

[[Page 57]]

set forth in paragraph (f) of this section or the corrective or removal 
action is exempt from the reporting requirements under Sec. 806.1(b).
    (b) The manufacturer or importer shall submit any report required by 
paragraph (a) of this section within 10-working days of initiating such 
correction or removal.
    (c) The manufacturer or importer shall include the following 
information in the report:
    (1) The seven digit registration number of the entity responsible 
for submission of the report of corrective or removal action (if 
applicable), the month, day, and year that the report is made, and a 
sequence number (i.e., 001 for the first report, 002 for the second 
report, 003 etc.), and the report type designation ``C'' or ``R''. For 
example, the complete number for the first correction report submitted 
on June 1, 1997, will appear as follows for a firm with the registration 
number 1234567: 1234567-6/1/97-001-C. The second correction report 
number submitted by the same firm on July 1, 1997, would be 1234567-7/1/
97-002-C etc. For removals, the number will appear as follows: 1234567-
6/1/97-001-R and 1234567-7/1/97-002-R, etc. Firms that do not have a 
seven digit registration number may use seven zeros followed by the 
month, date, year, and sequence number (i.e. 0000000-6/1/97-001-C for 
corrections and 0000000-7/1/97-001-R for removals). Reports received 
without a seven digit registration number will be assigned a seven digit 
central file number by the district office reviewing the reports.
    (2) The name, address, and telephone number of the manufacturer or 
importer, and the name, title, address, and telephone number of the 
manufacturer or importer representative responsible for conducting the 
device correction or removal.
    (3) The brand name and the common name, classification name, or 
usual name of the device and the intended use of the device.
    (4) Marketing status of the device, i.e., any applicable premarket 
notification number, premarket approval number, or indication that the 
device is a preamendments device, and the device listing number. A 
manufacturer or importer that does not have an FDA establishment 
registration number shall indicate in the report whether it has ever 
registered with FDA.
    (5) The model, catalog, or code number of the device and the 
manufacturing lot or serial number of the device or other identification 
number.
    (6) The manufacturer's name, address, telephone number, and contact 
person if different from that of the person submitting the report.
    (7) A description of the event(s) giving rise to the information 
reported and the corrective or removal actions that have been, and are 
expected to be taken.
    (8) Any illness or injuries that have occurred with use of the 
device. If applicable, include the medical device report numbers.
    (9) The total number of devices manufactured or distributed subject 
to the correction or removal and the number in the same batch, lot, or 
equivalent unit of production subject to the correction or removal.
    (10) The date of manufacture or distribution and the device's 
expiration date or expected life.
    (11) The names, addresses, and telephone numbers of all domestic and 
foreign consignees of the device and the dates and number of devices 
distributed to each such consignee.
    (12) A copy of all communications regarding the correction or 
removal and the names and addresses of all recipients of the 
communications not provided in accordance with paragraph (c)(11) of this 
section.
    (13) If any required information is not immediately available, a 
statement as to why it is not available and when it will be submitted.
    (d) If, after submitting a report under this part, a manufacturer or 
importer determines that the same correction or removal should be 
extended to additional lots or batches of the same device, the 
manufacturer or importer shall within 10-working days of initiating the 
extension of the correction or removal, amend the report by submitting 
an amendment citing the original report number assigned according to 
paragraph (c)(1) of this section, all of the information required by 
paragraph (c)(2), and any information required by paragraphs (c)(3) 
through (c)(12) of this

[[Page 58]]

section that is different from the information submitted in the original 
report. The manufacturer or importer shall also provide a statement in 
accordance with paragraph (c)(13) of this section for any required 
information that is not readily available.
    (e) A report submitted by a manufacturer or importer under this 
section (and any release by FDA of that report or information) does not 
necessarily reflect a conclusion by the manufacturer, importer, or FDA 
that the report or information constitutes an admission that the device 
caused or contributed to a death or serious injury. A manufacturer or 
importer need not admit, and may deny, that the report or information 
submitted under this section constitutes an admission that the device 
caused or contributed to a death or serious injury.
    (f) No report of a correction or removal is required under this 
part, if a report of the correction or removal is required and has been 
submitted under parts 803, 804, or 1004 of this chapter.

[62 FR 27191, May 19, 1997, as amended at 63 FR 42232, Aug. 7, 1998]



Sec. 806.20  Records of corrections and removals not required to be reported.

    (a) Each device manufacturer or importer who initiates a correction 
or removal of a device that is not required to be reported to FDA under 
Sec. 806.10 shall keep a record of such correction or removal.
    (b) Records of corrections and removals not required to be reported 
to FDA under Sec. 806.10 shall contain the following information:
    (1) The brand name, common or usual name, classification, name and 
product code if known, and the intended use of the device.
    (2) The model, catalog, or code number of the device and the 
manufacturing lot or serial number of the device or other identification 
number.
    (3) A description of the event(s) giving rise to the information 
reported and the corrective or removal action that has been, and is 
expected to be taken.
    (4) Justification for not reporting the correction or removal action 
to FDA, which shall contain conclusions and any followups, and be 
reviewed and evaluated by a designated person.
    (5) A copy of all communications regarding the correction or 
removal.
    (c) The manufacturer or importer shall retain records required under 
this section for a period of 2 years beyond the expected life of the 
device, even if the manufacturer or importer has ceased to manufacture 
or import the device. Records required to be maintained under paragraph 
(b) of this section must be transferred to the new manufacturer or 
importer of the device and maintained for the required period of time.

[62 FR 27191, May 19, 1997, as amended at 63 FR 42233, Aug. 7, 1998]



Sec. 806.30  FDA access to records.

    Each device manufacturer or importer required under this part to 
maintain records and every person who is in charge or custody of such 
records shall, upon request of an officer or employee designated by FDA 
and under section 704(e) of the act, permit such officer or employee at 
all reasonable times to have access to, and to copy and verify, such 
records and reports.

[63 FR 42233, Aug. 7, 1998]



Sec. 806.40  Public availability of reports.

    (a) Any report submitted under this part is available for public 
disclosure in accordance with part 20 of this chapter.
    (b) Before public disclosure of a report, FDA will delete from the 
report:
    (1) Any information that constitutes trade secret or confidential 
commercial or financial information under Sec. 20.61 of this chapter; 
and
    (2) Any personnel, medical, or similar information, including the 
serial numbers of implanted devices, which would constitute a clearly 
unwarranted invasion of personal privacy under Sec. 20.63 of this 
chapter or 5 U.S.C. 552(b)(6); provided, that except for the information 
under Sec. 20.61 of this chapter or 5 U.S.C. 552(b)(4), FDA will 
disclose to a patient who requests a report all the information in the 
report concerning that patient.

[[Page 59]]



PART 807--ESTABLISHMENT REGISTRATION AND DEVICE LISTING FOR MANUFACTURERS AND INITIAL IMPORTERS OF DEVICES--Table of Contents




                      Subpart A--General Provisions

Sec.
807.3  Definitions.

        Subpart B--Procedures for Domestic Device Establishments

807.20  Who must register and submit a device list.
807.21  Times for establishment registration and device listing.
807.22  How and where to register establishments and list devices.
807.25  Information required or requested for establishment registration 
          and device listing.
807.26  Amendments to establishment registration.
807.30  Updating device listing information.
807.31  Additional listing information.
807.35  Notification of registrant.
807.37  Inspection of establishment registration and device listings.
807.39  Misbranding by reference to establishment registration or to 
          registration number.

  Subpart C--Registration Procedures for Foreign Device Establishments

807.40  Establishment registration and device listing for U.S. agents of 
          foreign manufacturers of devices.

                          Subpart D--Exemptions

807.65  Exemptions for device establishments.

              Subpart E--Premarket Notification Procedures

807.81  When a premarket notification submission is required.
807.85  Exemption from premarket notification.
807.87  Information required in a premarket notification submission.
807.90  Format of a premarket notification submission.
807.92  Content and format of a 510(k) summary.
807.93  Content and format of a 510(k) statement.
807.94  Format of class III certification.
807.95  Confidentiality of information.
807.97  Misbranding by reference to premarket notification.
807.100  FDA action on a premarket notification.

    Authority: 21 U.S.C. 331, 351, 352, 360, 360c, 360e, 360i, 360j, 
371, 374.

    Source: 42 FR 42526, Aug. 23, 1977, unless otherwise noted.



                      Subpart A--General Provisions



Sec. 807.3  Definitions.

    (a) Act means the Federal Food, Drug, and Cosmetic Act.
    (b) Commercial distribution means any distribution of a device 
intended for human use which is held or offered for sale but does not 
include the following:
    (1) Internal or interplant transfer of a device between 
establishments within the same parent, subsidiary, and/or affiliate 
company;
    (2) Any distribution of a device intended for human use which has in 
effect an approved exemption for investigational use pursuant to section 
520(g) of the act and part 812 of this chapter; or
    (3) Any distribution of a device, before the effective date of part 
812 of this chapter, that was not introduced or delivered for 
introduction into interstate commerce for commercial distribution before 
May 28, 1976, and that is classified into class III under section 513(f) 
of the act: Provided, That the device is intended solely for 
investigational use, and under section 501(f)(2)(A) of the act the 
device is not required to have an approved premarket approval 
application as provided in section 515 of the act.
    (c) Establishment means a place of business under one management at 
one general physical location at which a device is manufactured, 
assembled, or otherwise processed.
    (d) Manufacture, preparation, propagation, compounding, assembly, or 
processing of a device means the making by chemical, physical, 
biological, or other procedures of any article that meets the definition 
of device in section 201(h) of the act. These terms include the 
following activities:
    (1) Repackaging or otherwise changing the container, wrapper, or 
labeling of any device package in furtherance of the distribution of the 
device from the original place of manufacture to the person who makes 
final delivery or sale to the ultimate consumer;

[[Page 60]]

    (2) Initial importation of devices manufactured in foreign 
establishments; or
    (3) Initiation of specifications for devices that are manufactured 
by a second party for subsequent commercial distribution by the person 
initiating specifications.
    (e) Official correspondent means the person designated by the owner 
or operator of an establishment as responsible for the following:
    (1) The annual registration of the establishment;
    (2) Contact with the Food and Drug Administration for device 
listing;
    (3) Maintenance and submission of a current list of officers and 
directors to the Food and Drug Administration upon the request of the 
Commissioner;
    (4) The receipt of pertinent correspondence from the Food and Drug 
Administration directed to and involving the owner or operator and/or 
any of the firm's establishments; and
    (5) The annual certification of medical device reports required by 
Sec. 804.30 of this chapter or forwarding the certification form to the 
person designated by the firm as responsible for the certification.
    (f) Owner or operator means the corporation, subsidiary, affiliated 
company, partnership, or proprietor directly responsible for the 
activities of the registering establishment.
    (g) Initial importer means any importer who furthers the marketing 
of a device from a foreign manufacturer to the person who makes the 
final delivery or sale of the device to the ultimate consumer or user, 
but does not repackage, or otherwise change the container, wrapper, or 
labeling of the device or device package.
    (h) Any term defined in section 201 of the act shall have that 
meaning.
    (i) Restricted device means a device for which the Commissioner, by 
regulation under Sec. 801.109 of this chapter or otherwise under section 
520(e) of the act, has restricted sale, distribution, or use only upon 
the written or oral authorization of a practitioner licensed by law to 
administer or use the device or upon such other conditions as the 
Commissioner may prescribe.
    (j) Classification name means the term used by the Food and Drug 
Administration and its classification panels to describe a device or 
class of devices for purposes of classifying devices under section 513 
of the act.
    (k) Representative sampling of advertisements means typical 
advertising material that gives the promotional claims made for the 
device.
    (l) Representative sampling of any other labeling means typical 
labeling material (excluding labels and package inserts) that gives the 
promotional claims made for the device.
    (m) Material change includes any change or modification in the 
labeling or advertisements that affects the identity or safety and 
effectiveness of the device. These changes may include, but are not 
limited to, changes in the common or usual or proprietary name, declared 
ingredients or components, intended use, contraindications, warnings, or 
instructions for use. Changes that are not material may include graphic 
layouts, grammar, or correction of typographical errors which do not 
change the content of the labeling, changes in lot number, and, for 
devices where the biological activity or known composition differs with 
each lot produced, the labeling containing the actual values for each 
lot.
    (n) 510(k) summary (summary of any information respecting safety and 
effectiveness) means a summary, submitted under section 513(i) of the 
act, of the safety and effectiveness information contained in a 
premarket notification submission upon which a determination of 
substantial equivalence can be based. Safety and effectiveness 
information refers to safety and effectiveness data and information 
supporting a finding of substantial equivalence, including all adverse 
safety and effectiveness information.
    (o) 510(k) statement means a statement, made under section 513(i) of 
the act, asserting that all information in a premarket notification 
submission regarding safety and effectiveness will be made available 
within 30 days of request by any person if the device described in the 
premarket notification submission is determined to be substantially 
equivalent. The information to be made available will be a duplicate of 
the premarket notification submission, including any adverse safety and

[[Page 61]]

effectiveness information, but excluding all patient identifiers, and 
trade secret or confidential commercial information, as defined in 
Sec. 20.61 of this chapter.
    (p) Class III certification means a certification that the submitter 
of the 510(k) has conducted a reasonable search of all known information 
about the class III device and other similar, legally marketed devices.
    (q) Class III summary means a summary of the types of safety and 
effectiveness problems associated with the type of device being compared 
and a citation to the information upon which the summary is based. The 
summary must be comprehensive and describe the problems to which the 
type of device is susceptible and the causes of such problems.
    (r) U.S.-designated agent means the person, residing in the United 
States, designated and authorized by the owner or operator of a foreign 
manufacturer who exports devices into the United States and is 
responsible for:
    (1) Submitting MDR reports,
    (2) Submitting annual certifications,
    (3) Acting as the official correspondent,
    (4) Submitting registration information,
    (5) Submitting device listing information, and
    (6) Submitting premarket notifications on behalf of the foreign 
manufacturer.
    (s) Wholesale distributor means any person (other than the 
manufacturer or the initial importer) who distributes a device from the 
original place of manufacture to the person who makes the final delivery 
or sale of the device to the ultimate consumer or user.

[42 FR 42526, Aug. 23, 1977, as amended at 43 FR 37997, Aug. 25, 1978; 
57 FR 18066, Apr. 28, 1992; 58 FR 46522, Sept. 1, 1993; 59 FR 64295, 
Dec. 14, 1994; 60 FR 63606, Dec. 11, 1995; 63 FR 51826, Sept. 29, 1998]

    Effective Date Note: At 61 FR 38347, July 23, 1996, in Sec. 807.3, 
paragraph (r) was stayed indefinitely.



        Subpart B--Procedures for Domestic Device Establishments



Sec. 807.20  Who must register and submit a device list.

    (a) An owner or operator of an establishment not exempt under 
section 510(g) of the act or subpart D of this part who is engaged in 
the manufacture, preparation, propagation, compounding, assembly, or 
processing of a device intended for human use is required to register 
and to submit listing information for those devices in commercial 
distribution, except that listing information may be submitted by the 
parent, subsidiary, or affiliate company for all the domestic or foreign 
establishments under the control of one of these organizations when 
operations are conducted at more than one establishment and there exists 
joint ownership and control among all the establishments. The term 
``device'' includes all in vitro diagnostic products and in vitro 
diagnostic biological products not subject to licensing under section 
351 of the Public Health Service Act. An owner or operator is required 
to register its name, places of business, and all establishments and to 
list the devices whether or not the output of the establishments or any 
particular device so listed enters interstate commerce. The registration 
and listing requirements shall pertain to any person who:
    (1) Initiates or develops specifications for a device that is to be 
manufactured by a second party for commercial distribution by the person 
initiating specifications;
    (2) Manufactures for commercial distribution a device either for 
itself or for another person. However, a person who only manufactures 
devices according to another person's specifications, for commercial 
distribution by the person initiating specifications, is not required to 
list those devices.
    (3) Repackages or relabels a device;
    (4) Acts as an initial importer;
    (5) Manufactures components or accessories which are ready to be 
used for any intended health-related purpose

[[Page 62]]

and are packaged or labeled for commercial distribution for such health-
related purpose, e.g., blood filters, hemodialysis tubing, or devices 
which of necessity must be further processed by a licensed practitioner 
or other qualified person to meet the needs of a particular patient, 
e.g., a manufacturer of ophthalmic lens blanks.
    (6) Acts as the U.S.-designated agent as defined in Sec. 807.3(r).
    (b) No registration or listing fee is required. Registration or 
listing does not constitute an admission or agreement or determination 
that a product is a device within the meaning of section 201(h) of the 
act.
    (c) Registration and listing requirements shall not pertain to any 
person who:
    (1) Manufacturers devices for another party who both initiated the 
specifications and commercially distributes the device;
    (2) Sterilizes devices on a contract basis for other registered 
facilities who commercially distribute the devices.
    (3) Acts as a wholesale distributor, as defined in Sec. 807.3(s), 
and who does not manufacture, repackage, process, or relabel a device.

[42 FR 42526, Aug. 23, 1977, as amended at 43 FR 37997, Aug. 25, 1978; 
58 FR 46522, Sept. 1, 1993; 60 FR 63606, Dec. 11, 1995; 63 FR 51826, 
Sept. 29, 1998]

    Effective Date Note: At 61 FR 38347, July 23, 1996, in Sec. 807.20, 
paragraph (a)(6) was stayed indefinitely.



Sec. 807.21  Times for establishment registration and device listing.

    (a) An owner or operator of an establishment who has not previously 
entered into an operation defined in Sec. 807.20 shall register within 
30 days after entering into such an operation and submit device listing 
information at that time. An owner or operator of an establishment shall 
update its registration information annually within 30 days after 
receiving registration forms from FDA. FDA will mail form FDA-2891a to 
the owners or operators of registered establishments according to a 
schedule based on the first letter of the name of the owner or operator. 
The schedule is as follows:

------------------------------------------------------------------------
  First letter of owner or operator name      Date FDA will mail forms
------------------------------------------------------------------------
A, B, C, D, E.............................   March.
F, G, H, I, J, K, L, M....................   June.
N, O, P, Q, R.............................   August.
S, T, U, V, W, X, Y, Z....................   November.
------------------------------------------------------------------------

    (b) Owners or operators of all registered establishments shall 
update their device listing information every June and December or, at 
their discretion, at the time the change occurs.

[58 FR 46522, Sept. 1, 1993]



Sec. 807.22  How and where to register establishments and list devices.

    (a) The first registration of a device establishment shall be on 
Form FDA-2891 (Initial Registration of Device Establishment). Forms are 
available upon request from the Office of Compliance, Center for Devices 
and Radiological Health (HFZ-307), Food and Drug Administration, 2098 
Gaither Rd., Rockville, MD 20850, or from Food and Drug Administration 
district offices. Subsequent annual registration shall be accomplished 
on Form FDD-2891a (Annual Registration of Device Establishment), which 
will be furnished by FDA to establishments whose registration for that 
year was validated under Sec. 807.35(a). The forms will be mailed to the 
owner or operators of all establishments via the official correspondent 
in accordance with the schedule as described in Sec. 807.21(a). The 
completed form shall be mailed to the address designated in this 
paragraph 30 days after receipt from FDA.
    (b) The initial listing of devices and subsequent June and December 
updatings shall be on form FD-2892 (Medical Device Listing). Forms are 
obtainable upon request as described in paragraph (a) of this section. A 
separate form FD-2892 shall be submitted for each device or device class 
listed with the Food and Drug Administration. Devices having variations 
in physical characteristics such as size, package, shape, color, or 
composition should be considered to be one device: Provided, The 
variation does not change the function or intended use of the device. In 
lieu of form FD-2892, tapes for computer input or hard copy computer 
output may by submitted if

[[Page 63]]

equivalent in all elements of information as specified in form FD-2892. 
All formats proposed for use in lieu of form FD-2892 require initial 
review and approval by the Food and Drug Administration.
    (c) The listing obligations of the initial importer are satisfied as 
follows:
    (1) The initial importer is not required to submit a form FDA-2892 
for those devices for which such initial importer did not initiate or 
develop the specifications for the device or repackage or relabel the 
device. However, the initial importer shall submit, for each device, the 
name and address of the manufacturer. Initial importers shall also be 
prepared to submit, when requested by FDA, the proprietary name, if any, 
and the common or usual name of each device for which they are the 
initial importers; and
    (2) The initial importer shall update the information required by 
paragraphs (c)(1) of this section at the intervals specified in 
Sec. 807.30.

[43 FR 37997, Aug. 25, 1978, as amended at 58 FR 46522, Sept. 1, 1993; 
60 FR 63606, Dec. 11, 1995; 63 FR 51826, Sept. 29, 1998]



Sec. 807.25  Information required or requested for establishment registration and device listing.

    (a) Form FD-2891 and Form FD-2891(a) are the approved forms for 
initially providing the information required by the act and for 
providing annual registration, respectively. The required information 
includes the name and street address of the device establishment, 
including post office ZIP Code, all trade names used by the 
establishment, and the business trading name of the owner or operator of 
such establishment.
    (b) The owner or operator shall identify the device activities of 
the establishment such as manufacturing, repackaging, or distributing 
devices.
    (c) Each owner or operator is required to maintain a listing of all 
officers, directors, and partners for each establishment he registers 
and to furnish this information to the Food and Drug Administration upon 
request.
    (d) Each owner or operator shall provide the name of an official 
correspondent who will serve as a point of contact between the Food and 
Drug Administration and the establishment for matters relating to the 
registration of device establishments and the listing of device 
products. All future correspondence relating to registration, including 
requests for the names of partners, officers, and directors, will be 
directed to this official correspondent. In the event no person is 
designated by the owner or operator, the owner or operator of the 
establishment will be the official correspondent.
    (e) The designation of an official correspondent does not in any 
manner affect the liability of the owner or operator of the 
establishment or any other individual under section 301(p) or any other 
provision of the act.
    (f) Form FD-2892 is the approved form for providing the device 
listing information required by the act. This required information 
includes the following:
    (1) The identification by classification name and number, 
proprietary name, and common or usual name of each device being 
manufactured, prepared, propagated, compounded, or processed for 
commercial distribution that has not been included in any list of 
devices previously submitted on form FD-2892.
    (2) The Code of Federal Regulations citation for any applicable 
standard for the device under section 514 of the act or section 358 of 
the Public Health Service Act.
    (3) The assigned Food and Drug Administration number of the approved 
application for each device listed that is subject to section 505 or 515 
of the act.
    (4) The name, registration number, and establishment type of every 
domestic or foreign device establishment under joint ownership and 
control of the owner or operator at which the device is manufactured, 
repackaged, or relabeled.
    (5) Whether the device, as labeled, is intended for distribution to 
and use by the general public.
    (6) Other general information requested on form FD-2892, i.e., (i) 
if the submission refers to a previously listed device, as in the case 
of an update, the document number from the initial listing document for 
the device, (ii) the reason for submission, (iii) the date on

[[Page 64]]

which the reason for submission occurred, (iv) the date that the form 
FD-2892 was completed, (v) the owner's or operator's name and 
identification number.
    (7) Labeling or other descriptive information (e.g., specification 
sheets or catalogs) adequate to describe the intended use of a device 
when the owner or operator is unable to find on the Food and Drug 
Administration list in the device listing package, an appropriate 
classification name for the device.

[42 FR 42526, Aug. 23, 1977, as amended at 43 FR 37998, Aug. 25, 1978; 
58 FR 46523, Sept. 1, 1993; 64 FR 404, Jan. 5, 1999]



Sec. 807.26  Amendments to establishment registration.

    Changes in individual ownership, corporate or partnership structure, 
or location of an operation defined in Sec. 807.3(c) shall be submitted 
on Form FD-2891(a). This information shall be submitted within 30 days 
of such changes. Changes in the names of officers and/or directors of 
the corporation(s) shall be filed with the establishment's official 
correspondent and shall be provided to the Food and Drug Administration 
upon receipt of a written request for this information.



Sec. 807.30  Updating device listing information.

    (a) Form FD-2892 shall be used to update device listing information. 
The preprinted original document number of each form FD-2892 on which 
the device was initially listed shall appear in block 2 on the form 
subsequently used to update the listing information for the device and 
on any correspondence related to the device.
    (b) An owner or operator shall update the device listing information 
during each June and December or, at its discretion, at the time the 
change occurs. Conditions that require updating and information to be 
submitted for each of these updates are as follows:
    (1) If an owner or operator introduces into commercial distribution 
a device identified with a classification name not currently listed by 
the owner or operator, then the owner or operator must submit form FD-
2892 containing all the information required by Sec. 807.25(f).
    (2) If an owner or operator discontinues commercial distribution of 
all devices in the same device class, i.e., with the same classification 
name, the owner or operator must submit form FD-2892 containing the 
original document number of the form FD-2892 on which the device class 
was initially listed, the reason for submission, the date of 
discontinuance, the owner or operator's name and identification number, 
the classification name and number, the proprietary name, and the common 
or usual name of the discontinued device.
    (3) If commercial distribution of a discontinued device identified 
on a form FD-2892 filed under paragraph (b)(2) of this section is 
resumed, the owner or operator must submit on form FD-2892 a notice of 
resumption containing: the original document number of the form 
initially used to list that device class, the reason for submission, 
date of resumption, and all other information required by 
Sec. 807.25(f).
    (4) If one or more classification names for a previously listed 
device with multiple classification names has been added or deleted, the 
owner or operator must supply the original document number from the form 
FD-2892 on which the device was initially listed and a supplemental 
sheet identifying the names of any new or deleted classification names.
    (5) Other changes to information on form FD-2892 will be updated as 
follows:
    (i) Whenever a change occurs only in the owner or operator name 
(block 6) or number (block 7), e.g., whenever one company's device line 
is purchased by another owner or operator, it will not be necessary to 
supply a separate form FD-2892 for each device. In such cases, the new 
owner or operator must follow the procedures in Sec. 807.26 and submit a 
letter informing the Food and Drug Administration of the original 
document number from form FD-2892 on which each device was initially 
listed for those devices affected by the change in ownership.
    (ii) The owner or operator must also submit update information 
whenever changes occur to the responses to the

[[Page 65]]

questions in blocks 12, 12a, 13, 13a, and 14 on form FD-2892, or 
whenever establishment registration numbers, establishment names, and/or 
activities are added to or deleted from blocks 15, 16, and 17 of form 
FD-2892. The owner or operator must supply the original document number 
from the form FD-2892 on which the device was initially listed, the 
reason for submission, and all other information required by 
Sec. 807.25(f).
    (6) Updating is not required if the above information has not 
changed since the previously submitted list. Also, updating is not 
required if changes occur in proprietary names, in common or usual names 
(blocks 10 and 11 of form FD-2892), or to supplemental lists of 
unclassified components or accessories.

[43 FR 37998, Aug. 25, 1978]



Sec. 807.31  Additional listing information.

    (a) Each owner or operator shall maintain a historical file 
containing the labeling and advertisements in use on the date of initial 
listing, and in use after October 10, 1978, but before the date of 
initial listing, as follows:
    (1) For each device subject to section 514 or 515 of the act that is 
not a restricted device, a copy of all labeling for the device;
    (2) For each restricted device, a copy of all labeling and 
advertisements for the device;
    (3) For each device that is neither restricted nor subject to 
section 514 or 515 of the act, a copy of all labels, package inserts, 
and a representative sampling of any other labeling.
    (b) In addition to the requirements set forth in paragraph (a) of 
this section, each owner or operator shall maintain in the historical 
file any labeling or advertisements in which a material change has been 
made anytime after initial listing.
    (c) Each owner or operator may discard labeling and advertisements 
from the historical file 3 years after the date of the last shipment of 
a discontinued device by an owner or operator.
    (d) Location of the file:
    (1) Currently existing systems for maintenance of labeling and 
advertising may be used for the purpose of maintaining the historical 
file as long as the information included in the systems fulfills the 
requirements of this section, but only if the labeling and 
advertisements are retrievable in a timely manner.
    (2) The contents of the historical file may be physically located in 
more than one place in the establishment or in more than one 
establishment provided there exists joint ownership and control among 
all the establishments maintaining the historical file. If no joint 
ownership and control exists, the registered establishment must provide 
the Food and Drug Administration with a letter authorizing the 
establishment outside its control to maintain the historical file.
    (3) A copy of the certification and disclosure statements as 
required by part 54 of this chapter shall be retained and physically 
located at the establishment maintaining the historical file.
    (e) Each owner or operator shall be prepared to submit to the Food 
and Drug Administration, only upon specific request, the following 
information:
    (1) For a device subject to section 514 or 515 of the act that is 
not a restricted device, a copy of all labeling for the device.
    (2) For a device that is a restricted device, a copy of all labeling 
for the device, a representative sampling of advertisements for the 
device, and for good cause, a copy of all advertisements for a 
particular device. A request for all advertisements will, where 
feasible, be accompanied by an explanation of the basis for such 
request.
    (3) For a device that is neither a restricted device, nor subject to 
section 514 of 515 of the act, the label and package insert for the 
device and a representative sampling of any other labeling for the 
device.
    (4) For a particular device, a statement of the basis upon which the 
registrant has determined that the device is not subject to section 514 
or 515 of the act.
    (5) For a particular device, a statement of the basis upon which the 
registrant has determined the device is not a restricted device.
    (6) For a particular device, a statement of the basis for 
determining that

[[Page 66]]

the product is a device rather than a drug.
    (7) For a device that the owner or operator has manufactured for 
distribution under a label other than its own, the names of all 
distributors for whom it has been manufactured.

[43 FR 37999, Aug. 25, 1978, as amended at 51 FR 33033, Sept. 18, 1986; 
63 FR 5253, Feb. 2, 1998]



Sec. 807.35  Notification of registrant.

    (a) The Commissioner will provide to the official correspondent, at 
the address listed on the form, a validated copy of Form FD-2891 or Form 
FD-2891(a) (whichever is applicable) as evidence of registration. A 
permanent registration number will be assigned to each device 
establishment registered in accordance with these regulations.
    (b) Owners and operators of device establishments who also 
manufacture or process blood or drug products at the same establishment 
shall also register with the Center for Biologics Evaluation and 
Research and Center for Drug Evaluation and Research, as appropriate. 
Blood products shall be listed with the Center for Biologics Evaluation 
and Research, Food and Drug Administration, pursuant to part 607 of this 
chapter; drug products shall be listed with the Center for Drug 
Evaluation and Research, Food and Drug Administration, pursuant to part 
207 of this chapter.
    (c) Although establishment registration and device listing are 
required to engage in the device activities described in Sec. 807.20, 
validation of registration and the assignment of a device listing number 
in itself does not establish that the holder of the registration is 
legally qualified to deal in such devices and does not represent a 
determination by the Food and Drug Administration as to the status of 
any device.

[42 FR 42526, Aug. 23, 1977, as amended at 43 FR 37999, Aug. 25, 1978; 
53 FR 11252, Apr. 6, 1988]



Sec. 807.37  Inspection of establishment registration and device listings.

    (a) A copy of the forms FD-2891 and FD-2891a filed by the registrant 
will be available for inspection in accordance with section 510(f) of 
the act, at the Center for Devices and Radiological Health (HFZ-342), 
Food and Drug Administration, Department of Health and Human Services, 
1390 Piccard Dr., Rockville, MD 20850. In addition, there will be 
available for inspection at each of the Food and Drug Administration 
district offices the same information for firms within the geographical 
area of such district office. Upon request, verification of registration 
number or location of a registered establishment will be provided.
    (b)(1) The following information filed under the device listing 
requirements will be available for public disclosure:
    (i) Each form FD-2892 submitted;
    (ii) All labels submitted;
    (iii) All labeling submitted;
    (iv) All advertisements submitted;
    (v) All data or information that has already become a matter of 
public knowledge.
    (2) Requests for device listing information identified in paragraph 
(b)(1) of this section should be directed to the Center for Devices and 
Radiological Health (HFZ-342), Food and Drug Administration, Department 
of Health and Human Services, 1390 Piccard Dr., Rockville, MD 20850.
    (3) Requests for device listing information not identified in 
paragraph (b)(1) of this section shall be submitted and handled in 
accordance with part 20 of this chapter.

[43 FR 37999, Aug. 25, 1978, as amended at 53 FR 11252, Apr. 6, 1988; 55 
FR 11169, Mar. 27, 1990]



Sec. 807.39  Misbranding by reference to establishment registration or to registration number.

    Registration of a device establishment or assignment of a 
registration number does not in any way denote approval of the 
establishment or its products. Any representation that creates an 
impression of official approval because of registration or possession of 
a registration number is misleading and constitutes misbranding.

[[Page 67]]



  Subpart C--Registration Procedures for Foreign Device Establishments



Sec. 807.40  Establishment registration and device listing for U.S. agents of foreign manufacturers of devices.

    (a) Each foreign device manufacturer who exports devices into the 
United States shall designate a person as their U.S.-designated agent, 
who is responsible for:
    (1) Submitting MDR reports,
    (2) Submitting annual certifications,
    (3) Acting as the official correspondent,
    (4) Submitting registration information,
    (5) Submitting device listing information, and
    (6) Submitting premarket notifications.
    (b) The foreign manufacturer shall provide FDA with a statement of 
authorization for their U.S.-designate to perform MDR reporting duties 
under part 803 of this chapter, and to register, list, and submit 
premarket notifications under this part. The foreign manufacturer must 
provide this statement of authorization along with the name, address, 
and telephone number of the person initially designated, or any 
subsequent person designated as the U.S.-designated agent, within 5 days 
of the initial or subsequent designation. Information shall be sent to 
the Center for Devices and Radiological Health, Medical Device 
Reporting, Food and Drug Administration, P.O. Box 3002, Rockville, MD 
20847-3002.
    (c) The U.S.-designated agent of a foreign device manufacturer that 
exports devices into the United States is required to register the 
foreign manufacturer's establishments or places of business, and to list 
the foreign manufacturer's devices, in accordance with subpart B of this 
part, unless exempt under subpart D of this part, and to submit 
premarket notifications in accordance with subpart E of this part. The 
information submitted shall be in the English language.

[60 FR 63606, Dec. 11, 1995]

    Effective Date Note: At 61 FR 38347, July 23, 1996, Sec. 807.40 was 
stayed indefinitely.



                          Subpart D--Exemptions



Sec. 807.65  Exemptions for device establishments.

    The following classes of persons are exempt from registration in 
accordance with Sec. 807.20 under the provisions of section 510(g) (1), 
(2), and (3) of the act, or because the Commissioner has found, under 
section 510(g)(4) of the act, that such registration is not necessary 
for the protection of the public health:
    (a) A manufacturer of raw materials or components to be used in the 
manufacture or assembly of a device who would otherwise not be required 
to register under the provisions of this part.
    (b) A manufacturer of devices to be used solely for veterinary 
purposes.
    (c) A manufacturer of general purpose articles such as chemical 
reagents or laboratory equipment whose uses are generally known by 
persons trained in their use and which are not labeled or promoted for 
medical uses.
    (d) Licensed practitioners, including physicians, dentists, and 
optometrists, who manufacture or otherwise alter devices solely for use 
in their practice.
    (e) Pharmacies, surgical supply outlets, or other similar retail 
establishments making final delivery or sale to the ultimate user. This 
exemption also applies to a pharmacy or other similar retail 
establishment that purchases a device for subsequent distribution under 
its own name, e.g., a properly labeled health aid such as an elastic 
bandage or crutch, indicating ``distributed by'' or ``manufactured for'' 
followed by the name of the pharmacy.
    (f) Persons who manufacture, prepare, propagate, compound, or 
process devices solely for use in research, teaching, or analysis and do 
not introduce such devices into commercial distribution.
    (g) [Reserved]
    (h) Carriers by reason of their receipt, carriage, holding or 
delivery of devices in the usual course of business as carriers.
    (i) Persons who dispense devices to the ultimate consumer or whose 
major responsibility is to render a service necessary to provide the 
consumer (i.e., patient, physician, layman, etc.) with a device or the 
benefits to be derived

[[Page 68]]

from the use of a device; for example, a hearing aid dispenser, 
optician, clinical laboratory, assembler of diagnostic x-ray systems, 
and personnel from a hospital, clinic, dental laboratory, orthotic or 
prosthetic retail facility, whose primary responsibility to the ultimate 
consumer is to dispense or provide a service through the use of a 
previously manufactured device.

[42 FR 42526, Aug. 23, 1977, as amended at 58 FR 46523, Sept. 1, 1993; 
61 FR 44615, Aug. 28, 1996; 65 FR 17136, Mar. 31, 2000]



              Subpart E--Premarket Notification Procedures



Sec. 807.81  When a premarket notification submission is required.

    (a) Except as provided in paragraph (b) of this section, each person 
who is required to register his establishment pursuant to Sec. 807.20 
must submit a premarket notification submission to the Food and Drug 
Administration at least 90 days before he proposes to begin the 
introduction or delivery for introduction into interstate commerce for 
commercial distribution of a device intended for human use which meets 
any of the following criteria:
    (1) The device is being introduced into commercial distribution for 
the first time; that is, the device is not of the same type as, or is 
not substantially equivalent to, (i) a device in commercial distribution 
before May 28, 1976, or (ii) a device introduced for commercial 
distribution after May 28, 1976, that has subsequently been reclassified 
into class I or II.
    (2) The device is being introduced into commercial distribution for 
the first time by a person required to register, whether or not the 
device meets the criteria in paragraph (a)(1) of this section.
    (3) The device is one that the person currently has in commercial 
distribution or is reintroducing into commercial distribution, but that 
is about to be significantly changed or modified in design, components, 
method of manufacture, or intended use. The following constitute 
significant changes or modifications that require a premarket 
notification:
    (i) A change or modification in the device that could significantly 
affect the safety or effectiveness of the device, e.g., a significant 
change or modification in design, material, chemical composition, energy 
source, or manufacturing process.
    (ii) A major change or modification in the intended use of the 
device.
    (b) A premarket notification under this subpart is not required for 
a device for which a premarket approval application under section 515 of 
the act, or for which a petition to reclassify under section 513(f)(2) 
of the act, is pending before the Food and Drug Administration.
    (c) In addition to complying with the requirements of this part, 
owners or operators of device establishments that manufacture radiation-
emitting electronic products, as defined in Sec. 1000.3 of this chapter, 
shall comply with the reporting requirements of part 1002 of this 
chapter.



Sec. 807.85  Exemption from premarket notification.

    (a) A device is exempt from the premarket notification requirements 
of this subpart if the device intended for introduction into commercial 
distribution is not generally available in finished form for purchase 
and is not offered through labeling or advertising by the manufacturer, 
importer, or distributor thereof for commercial distribution, and the 
device meets one of the following conditions:
    (1) It is intended for use by a patient named in the order of the 
physician or dentist (or other specially qualified person); or
    (2) It is intended solely for use by a physician or dentist (or 
other specially qualified person) and is not generally available to, or 
generally used by, other physicians or dentists (or other specially 
qualified persons).
    (b) A distributor who places a device into commercial distribution 
for the first time under his own name and a repackager who places his 
own name on a device and does not change any other labeling or otherwise 
affect the device shall be exempted from the premarket notification 
requirements of this subpart if:
    (1) The device was in commercial distribution before May 28, 1976; 
or

[[Page 69]]

    (2) A premarket notification submission was filed by another person.



Sec. 807.87  Information required in a premarket notification submission.

    Each premarket notification submission shall contain the following 
information:
    (a) The device name, including both the trade or proprietary name 
and the common or usual name or classification name of the device.
    (b) The establishment registration number, if applicable, of the 
owner or operator submitting the premarket notification submission.
    (c) The class in which the device has been put under section 513 of 
the act and, if known, its appropriate panel; or, if the owner or 
operator determines that the device has not been classified under such 
section, a statement of that determination and the basis for the 
person's determination that the device is not so classified.
    (d) Action taken by the person required to register to comply with 
the requirements of the act under section 514 for performance standards.
    (e) Proposed labels, labeling, and advertisements sufficient to 
describe the device, its intended use, and the directions for its use. 
Where applicable, photographs or engineering drawings should be 
supplied.
    (f) A statement indicating the device is similar to and/or different 
from other products of comparable type in commercial distribution, 
accompanied by data to support the statement. This information may 
include an identification of similar products, materials, design 
considerations, energy expected to be used or delivered by the device, 
and a description of the operational principles of the device.
    (g) Where a person required to register intends to introduce into 
commercial distribution a device that has undergone a significant change 
or modification that could significantly affect the safety or 
effectiveness of the device, or the device is to be marketed for a new 
or different indication for use, the premarket notification submission 
must include appropriate supporting data to show that the manufacturer 
has considered what consequences and effects the change or modification 
or new use might have on the safety and effectiveness of the device.
    (h) A 510(k) summary as described in Sec. 807.92 or a 510(k) 
statement as described in Sec. 807.93.
    (i) A financial certification or disclosure statement or both, as 
required by part 54 of this chapter.
    (j) For submissions claiming substantial equivalence to a device 
which has been classified into class III under section 513(b) of the 
act:
    (1) Which was introduced or delivered for introduction into 
interstate commerce for commercial distribution before December 1, 1990; 
and
    (2) For which no final regulation requiring premarket approval has 
been issued under section 515(b) of the act, a summary of the types of 
safety and effectiveness problems associated with the type of devices 
being compared and a citation to the information upon which the summary 
is based (class III summary). The 510(k) submitter shall also certify 
that a reasonable search of all information known or otherwise available 
about the class III device and other similar legally marketed devices 
has been conducted (class III certification), as described in 
Sec. 807.94. This information does not refer to information that already 
has been submitted to the Food and Drug Administration (FDA) under 
section 519 of the act. FDA may require the submission of the adverse 
safety and effectiveness data described in the class III summary or 
citation.
    (k) A statement that the submitter believes, to the best of his or 
her knowledge, that all data and information submitted in the premarket 
notification are truthful and accurate and that no material fact has 
been omitted.
    (l) Any additional information regarding the device requested by the 
Commissioner that is necessary for the Commissioner to make a finding as 
to whether or not the device is substantially equivalent to a device in 
commercial distribution. A request for additional information will 
advise the owner or operator that there is insufficient information 
contained in the original premarket notification submission for the 
Commissioner to make this determination and that the owner

[[Page 70]]

or operator may either submit the requested data or a new premarket 
notification containing the requested information at least 90 days 
before the owner or operator intends to market the device, or submit a 
premarket approval application in accordance with section 515 of the 
act. If the additional information is not submitted within 30 days 
following the date of the request, the Commissioner will consider the 
premarket notification to be withdrawn.

(Information collection requirements in this section were approved by 
the Office of Management and Budget (OMB) and assigned OMB control 
number 0910-0281)

[42 FR 42526, Aug 23, 1977, as amended at 57 FR 18066, Apr. 28, 1992; 59 
FR 64295, Dec. 14, 1994; 63 FR 5253, Feb. 2, 1998]



Sec. 807.90  Format of a premarket notification submission.

    Each premarket notification submission pursuant to this part shall 
be submitted in accordance with this section. Each submission shall:
    (a)(1) For devices regulated by the Center for Devices and 
Radiological Health, be addressed to the Food and Drug Administration, 
Center for Devices and Radiological Health (HFZ-401), 9200 Corporate 
Blvd., Rockville, MD 20850.
    (2) For devices regulated by the Center for Biologics Evaluation and 
Research, be addressed to the Food and Drug Administration, Center for 
Biologics Evaluation and Research, Document Control Room (HFM-99), 1401 
Rockville Pike, Rockville, MD 20852-1448. Information about devices 
regulated by the Center for Biologics Evaluation and Research is 
available at http://www.fda.gov/cber/dap/devlst.htm on the Internet.
    (3) All inquiries regarding a premarket notification submission 
should be in writing and sent to one of the addresses above.
    (b) Be bound into a volume or volumes, where necessary.
    (c) Be submitted in duplicate on standard size paper, including the 
original and two copies of the cover letter.
    (d) Be submitted separately for each product the manufacturer 
intends to market.
    (e) Designated ``510(k) Notification'' in the cover letter.

[42 FR 42526, Aug. 23, 1977, as amended at 53 FR 11252, Apr. 6, 1988; 55 
FR 11169, Mar. 27, 1990; 65 FR 17137, Mar. 31, 2000]



Sec. 807.92  Content and format of a 510(k) summary.

    (a) A 510(k) summary shall be in sufficient detail to provide an 
understanding of the basis for a determination of substantial 
equivalence. FDA will accept summaries as well as amendments thereto 
until such time as FDA issues a determination of substantial 
equivalence. All 510(k) summaries shall contain the following 
information:
    (1) The submitter's name, address, telephone number, a contact 
person, and the date the summary was prepared;
    (2) The name of the device, including the trade or proprietary name 
if applicable, the common or usual name, and the classification name, if 
known;
    (3) An identification of the legally marketed device to which the 
submitter claims equivalence. A legally marketed device to which a new 
device may be compared for a determination regarding substantial 
equivalence is a device that was legally marketed prior to May 28, 1976, 
or a device which has been reclassified from class III to class II or I 
(the predicate), or a device which has been found to be substantially 
equivalent through the 510(k) premarket notification process;
    (4) A description of the device that is the subject of the premarket 
notification submission, such as might be found in the labeling or 
promotional material for the device, including an explanation of how the 
device functions, the scientific concepts that form the basis for the 
device, and the significant physical and performance characteristics of 
the device, such as device design, material used, and physical 
properties;
    (5) A statement of the intended use of the device that is the 
subject of the premarket notification submission, including a general 
description of the diseases or conditions that the device will diagnose, 
treat, prevent, cure, or mitigate, including a description,

[[Page 71]]

where appropriate, of the patient population for which the device is 
intended. If the indication statements are different from those of the 
legally marketed device identified in paragraph (a)(3) of this section, 
the 510(k) summary shall contain an explanation as to why the 
differences are not critical to the intended therapeutic, diagnostic, 
prosthetic, or surgical use of the device, and why the differences do 
not affect the safety and effectiveness of the device when used as 
labeled; and
    (6) If the device has the same technological characteristics (i.e., 
design, material, chemical composition, energy source) as the predicate 
device identified in paragraph (a)(3) of this section, a summary of the 
technological characteristics of the new device in comparison to those 
of the predicate device. If the device has different technological 
characteristics from the predicate device, a summary of how the 
technological characteristics of the device compare to a legally 
marketed device identified in paragraph (a)(3) of this section.
    (b) 510(k) summaries for those premarket submissions in which a 
determination of substantial equivalence is also based on an assessment 
of performance data shall contain the following information:
    (1) A brief discussion of the nonclinical tests submitted, 
referenced, or relied on in the premarket notification submission for a 
determination of substantial equivalence;
    (2) A brief discussion of the clinical tests submitted, referenced, 
or relied on in the premarket notification submission for a 
determination of substantial equivalence. This discussion shall include, 
where applicable, a description of the subjects upon whom the device was 
tested, a discussion of the safety or effectiveness data obtained from 
the testing, with specific reference to adverse effects and 
complications, and any other information from the clinical testing 
relevant to a determination of substantial equivalence; and
    (3) The conclusions drawn from the nonclinical and clinical tests 
that demonstrate that the device is as safe, as effective, and performs 
as well as or better than the legally marketed device identified in 
paragraph (a)(3) of this section.
    (c) The summary should be in a separate section of the submission, 
beginning on a new page and ending on a page not shared with any other 
section of the premarket notification submission, and should be clearly 
identified as a ``510(k) summary.''
    (d) Any other information reasonably deemed necessary by the agency.

[57 FR 18066, Apr. 28, 1992, as amended at 59 FR 64295, Dec. 14, 1994]



Sec. 807.93  Content and format of a 510(k) statement.

    (a)(1) A 510(k) statement submitted as part of a premarket 
notification shall state as follows:

    I certify that, in my capacity as (the position held in company by 
person required to submit the premarket notification, preferably the 
official correspondent in the firm), of (company name), I will make 
available all information included in this premarket notification on 
safety and effectiveness within 30 days of request by any person if the 
device described in the premarket notification submission is determined 
to be substantially equivalent. The information I agree to make 
available will be a duplicate of the premarket notification submission, 
including any adverse safety and effectiveness information, but 
excluding all patient identifiers, and trade secret and confidential 
commercial information, as defined in 21 CFR 20.61.

    (2) The statement in paragraph (a)(1) of this section should be 
signed by the certifier, made on a separate page of the premarket 
notification submission, and clearly identified as ``510(k) statement.''
    (b) All requests for information included in paragraph (a) of this 
section shall be made in writing to the certifier, whose name will be 
published by FDA on the list of premarket notification submissions for 
which substantial equivalence determinations have been made.
    (c) The information provided to requestors will be a duplicate of 
the premarket notification submission, including any adverse 
information, but excluding all patient identifiers, and

[[Page 72]]

trade secret and confidential commercial information as defined in 
Sec. 20.61 of this chapter.

[59 FR 64295, Dec. 14, 1994]



Sec. 807.94  Format of a class III certification.

    (a) A class III certification submitted as part of a premarket 
notification shall state as follows:

    I certify, in my capacity as (position held in company), of (company 
name), that I have conducted a reasonable search of all information 
known or otherwise available about the types and causes of safety or 
effectiveness problems that have been reported for the (type of device). 
I further certify that I am aware of the types of problems to which the 
(type of device) is susceptible and that, to the best of my knowledge, 
the following summary of the types and causes of safety or effectiveness 
problems about the (type of device) is complete and accurate.

    (b) The statement in paragraph (a) of this section should be signed 
by the certifier, clearly identified as ``class III certification,'' and 
included at the beginning of the section of the premarket notification 
submission that sets forth the class III summary.

[59 FR 64296, Dec. 14, 1994]



Sec. 807.95  Confidentiality of information.

    (a) The Food and Drug Administration will disclose publicly whether 
there exists a premarket notification submission under this part:
    (1) Where the device is on the market, i.e., introduced or delivered 
for introduction into interstate commerce for commercial distribution;
    (2) Where the person submitting the premarket notification 
submission has disclosed, through advertising or any other manner, his 
intent to market the device to scientists, market analysts, exporters, 
or other individuals who are not employees of, or paid consultants to, 
the establishment and who are not in an advertising or law firm pursuant 
to commercial arrangements with appropriate safeguards for secrecy; or
    (3) Where the device is not on the market and the intent to market 
the device has not been so disclosed, except where the submission is 
subject to an exception under paragraph (b) or (c) of this section.
    (b) The Food and Drug Administration will not disclose publicly the 
existence of a premarket notification submission for a device that is 
not on the market and where the intent to market the device has not been 
disclosed for 90 days from the date of receipt of the submission, if:
    (1) The person submitting the premarket notification submission 
requests in the submission that the Food and Drug Administration hold as 
confidential commercial information the intent to market the device and 
submits a written certification to the Commissioner:
    (i) That the person considers his intent to market the device to be 
confidential commercial information;
    (ii) That neither the person nor, to the best of his knowledge, 
anyone else, has disclosed through advertising or any other manner, his 
intent to market the device to scientists, market analysts, exporters, 
or other individuals, except employees of, or paid consultants to, the 
establishment or individuals in an advertising or law firm pursuant to 
commercial arrangements with appropriate safeguards for secrecy;
    (iii) That the person will immediately notify the Food and Drug 
Administration if he discloses the intent to market the device to 
anyone, except employees of, or paid consultants to, the establishment 
or individuals in an advertising or law firm pursuant to commercial 
arrangements with appropriate safeguards for secrecy;
    (iv) That the person has taken precautions to protect the 
confidentiality of the intent to market the device; and
    (v) That the person understands that the submission to the 
government of false information is prohibited by 18 U.S.C. 1001 and 21 
U.S.C. 331(q); and
    (2) The Commissioner agrees that the intent to market the device is 
confidential commercial information.
    (c) Where the Commissioner determines that the person has complied 
with the procedures described in paragraph (b) of this section with 
respect to a device that is not on the market and where the intent to 
market the device has not been disclosed, and the Commissioner agrees 
that the intent to

[[Page 73]]

market the device is confidential commercial information, the 
Commissioner will not disclose the existence of the submission for 90 
days from the date of its receipt by the agency. In addition, the 
Commissioner will continue not to disclose the existence of such a 
submission for the device for an additional time when any of the 
following occurs:
    (1) The Commissioner requests in writing additional information 
regarding the device pursuant to Sec. 807.87(h), in which case the 
Commissioner will not disclose the existence of the submission until 90 
days after the Food and Drug Administration's receipt of a complete 
premarket notification submission;
    (2) The Commissioner determines that the device intended to be 
introduced is a class III device and cannot be marketed without 
premarket approval or reclassification, in which case the Commissioner 
will not disclose the existence of the submission unless a petition for 
reclassification is submitted under section 513(f)(2) of the act and its 
existence can be disclosed under Sec. 860.5(d) of this chapter; or
    (d) FDA will make a 510(k) summary of the safety and effectiveness 
data available to the public within 30 days of the issuance of a 
determination that the device is substantially equivalent to another 
device. Accordingly, even when a 510(k) submitter has complied with the 
conditions set forth in paragraphs (b) and (c) of this section, 
confidentiality for a premarket notification submission cannot be 
granted beyond 30 days after FDA issues a determination of equivalency.
    (e) Data or information submitted with, or incorporated by reference 
in, a premarket notification submission (other than safety and 
effectiveness data that have not been disclosed to the public) shall be 
available for disclosure by the Food and Drug Administration when the 
intent to market the device is no longer confidential in accordance with 
this section, unless exempt from public disclosure in accordance with 
part 20 of this chapter. Upon final classification, data and information 
relating to safety and effectiveness of a device classified in class I 
(general controls) or class II (performance standards) shall be 
available for public disclosure. Data and information relating to safety 
and effectiveness of a device classified in class III (premarket 
approval) that have not been released to the public shall be retained as 
confidential unless such data and information become available for 
release to the public under Sec. 860.5(d) or other provisions of this 
chapter.

[42 FR 42526, Aug. 23, 1977, as amended at 53 FR 11252, Apr. 6, 1988; 57 
FR 18067, Apr. 28, 1992; 59 FR 64296, Dec. 14, 1994]



Sec. 807.97  Misbranding by reference to premarket notification.

    Submission of a premarket notification in accordance with this 
subpart, and a subsequent determination by the Commissioner that the 
device intended for introduction into commercial distribution is 
substantially equivalent to a device in commercial distribution before 
May 28, 1976, or is substantially equivalent to a device introduced into 
commercial distribution after May 28, 1976, that has subsequently been 
reclassified into class I or II, does not in any way denote official 
approval of the device. Any representation that creates an impression of 
official approval of a device because of complying with the premarket 
notification regulations is misleading and constitutes misbranding.



Sec. 807.100  FDA action on a premarket notification.

    (a) After review of a premarket notification, FDA will:
    (1) Issue an order declaring the device to be substantially 
equivalent to a legally marketed predicate device;
    (2) Issue an order declaring the device to be not substantially 
equivalent to any legally marketed predicate device;
    (3) Request additional information; or
    (4) Withhold the decision until a certification or disclosure 
statement is submitted to FDA under part 54 of this chapter.
    (5) Advise the applicant that the premarket notification is not 
required. Until the applicant receives an order declaring a device 
substantially equivalent, the applicant may not proceed to market the 
device.

[[Page 74]]

    (b) FDA will determine that a device is substantially equivalent to 
a predicate device using the following criteria:
    (1) The device has the same intended use as the predicate device; 
and
    (2) The device:
    (i) Has the same technological characteristics as the predicate 
device; or
    (ii)(A) Has different technological characteristics, such as a 
significant change in the materials, design, energy source, or other 
features of the device from those of the predicate device;
    (B) The data submitted establishes that the device is substantially 
equivalent to the predicate device and contains information, including 
clinical data if deemed necessary by the Commissioner, that demonstrates 
that the device is as safe and as effective as a legally marketed 
device; and
    (C) Does not raise different questions of safety and effectiveness 
than the predicate device.
    (3) The predicate device has not been removed from the market at the 
initiative of the Commissioner of Food and Drugs or has not been 
determined to be misbranded or adulterated by a judicial order.

[57 FR 58403, Dec. 10, 1992, as amended at 63 FR 5253, Feb. 2, 1998]



PART 808--EXEMPTIONS FROM FEDERAL PREEMPTION OF STATE AND LOCAL MEDICAL DEVICE REQUIREMENTS--Table of Contents




                      Subpart A--General Provisions

Sec.
808.1  Scope.
808.3  Definitions.
808.5  Advisory opinions.

                     Subpart B--Exemption Procedures

808.20  Application.
808.25  Procedures for processing an application.
808.35  Revocation of an exemption.

        Subpart C--Listing of Specific State and Local Exemptions

808.51  Alabama.
808.52  Alaska.
808.53  Arizona.
808.55  California
808.57  Connecticut.
808.59  Florida.
808.61  Hawaii.
808.67  Kentucky.
808.69  Maine.
808.71  Massachusetts.
808.73  Minnesota.
808.74  Mississippi.
808.77  Nebraska.
808.80  New Jersey.
808.81  New Mexico.
808.82  New York.
808.85  Ohio.
808.87  Oregon.
808.88  Pennsylvania.
808.89  Rhode Island.
808.93  Texas.
808.94  Utah.
808.97  Washington.
808.98  West Virginia.
808.101  District of Columbia.

    Authority: 21 U.S.C. 360j, 360k, 371.

    Source: 43 FR 18665, May 2, 1978, unless otherwise noted.



                      Subpart A--General Provisions



Sec. 808.1  Scope.

    (a) This part prescribes procedures for the submission, review, and 
approval of applications for exemption from Federal preemption of State 
and local requirements applicable to medical devices under section 521 
of the act.
    (b) Section 521(a) of the act contains special provisions governing 
the regulation of devices by States and localities. That section 
prescribes a general rule that after May 28, 1976, no State or political 
subdivision of a State may establish or continue in effect any 
requirement with respect to a medical device intended for human use 
having the force and effect of law (whether established by statute, 
ordinance, regulation, or court decision), which is different from, or 
in addition to, any requirement applicable to such device under any 
provision of the act and which relates to the safety or effectiveness of 
the device or to any other matter included in a requirement applicable 
to the device under the act.
    (c) Section 521(b) of the act contains a provision whereby the 
Commissioner of Food and Drugs may, upon application by a State or 
political subdivision, allow imposition of a requirement which is 
different from, or in addition to, any requirement applicable under the 
act to the device (and which is

[[Page 75]]

thereby preempted) by promulgating a regulation in accordance with this 
part exempting the State or local requirement from preemption. The 
granting of an exemption does not affect the applicability to the device 
of any requirements under the act. The Commissioner may promulgate an 
exemption regulation for the preempted requirement if he makes either of 
the following findings:
    (1) That the requirement is more stringent than a requirement under 
the act applicable to the device; or
    (2) That the requirement is required by compelling local conditions 
and compliance with the requirement would not cause the device to be in 
violation of any applicable requirement under the act.
    (d) State or local requirements are preempted only when the Food and 
Drug Administration has established specific counterpart regulations or 
there are other specific requirements applicable to a particular device 
under the act, thereby making any existing divergent State or local 
requirements applicable to the device different from, or in addition to, 
the specific Food and Drug Administration requirements. There are other 
State or local requirements that affect devices that are not preempted 
by section 521(a) of the act because they are not ``requirements 
applicable to a device'' within the meaning of section 521(a) of the 
act. The following are examples of State or local requirements that are 
not regarded as preempted by section 521 of the act:
    (1) Section 521(a) does not preempt State or local requirements of 
general applicability where the purpose of the requirement relates 
either to other products in addition to devices (e.g., requirements such 
as general electrical codes, and the Uniform Commercial Code (warranty 
of fitness)), or to unfair trade practices in which the requirements are 
not limited to devices.
    (2) Section 521(a) does not preempt State or local requirements that 
are equal to, or substantially identical to, requirements imposed by or 
under the act.
    (3) Section 521(a) does not preempt State or local permits, 
licensing, registration, certification, or other requirements relating 
to the approval or sanction of the practice of medicine, dentistry, 
optometry, pharmacy, nursing, podiatry, or any other of the healing arts 
or allied medical sciences or related professions or occupations that 
administer, dispense, or sell devices. However, regulations issued under 
section 520(e) or (g) of the act may impose restrictions on the sale, 
distribution, or use of a device beyond those prescribed in State or 
local requirements. If there is a conflict between such restrictions and 
State or local requirements, the Federal regulations shall prevail.
    (4) Section 521(a) does not preempt specifications in contracts 
entered into by States or localities for procurement of devices.
    (5) Section 521(a) does not preempt criteria for payment of State or 
local obligations under Medicaid and similar Federal, State or local 
health-care programs.
    (6)(i) Section 521(a) does not preempt State or local requirements 
respecting general enforcement, e.g., requirements that State inspection 
be permitted of factory records concerning all devices, registration, 
and licensing requirements for manufacturers and others, and prohibition 
of manufacture of devices in unlicensed establishments. However, Federal 
regulations issued under sections 519 and 520(f) of the act may impose 
requirements for records and reports and good manufacturing practices 
beyond those prescribed in State or local requirements. If there is a 
conflict between such regulations and State or local requirements, the 
Federal regulations shall prevail.
    (ii) Generally, section 521(a) does not preempt a State or local 
requirement prohibiting the manufacture of adulterated or misbranded 
devices. Where, however, such a prohibition has the effect of 
establishing a substantive requirement for a specific device, e.g., a 
specific labeling requirement, then the prohibition will be preempted if 
the requirement is different from, or in addition to, a Federal 
requirement established under the act. In determining whether such a 
requirement is preempted, the determinative factor is how the 
requirement is interpreted and

[[Page 76]]

enforced by the State or local government and not the literal language 
of the statute, which may be identical to a provision in the act.
    (7) Section 521(a) does not preempt State or local provisions 
respecting delegations of authority and related administrative matters 
relating to devices.
    (8) Section 521(a) does not preempt a State or local requirement 
whose sole purpose is raising revenue or charging fees for services, 
registration, or regulatory programs.
    (9) Section 521(a) does not preempt State or local requirements of 
the types that have been developed under the Atomic Energy act of 1954 
(42 U.S.C. 2011 note), as amended, the Radiation Control for Health and 
Safety Act of 1968 (Pub. L. 90-602 (42 U.S.C. 263b et seq.)) and other 
Federal statutes, until such time as the Food and Drug Administration 
issues specific requirements under the Federal Food, Drug, and Cosmetic 
Act applicable to these types of devices.
    (10) Part 820 of this chapter (21 CFR part 820) (CGMP requirements) 
does not preempt remedies created by States or Territories of the United 
States, the District of Columbia, or the Commonwealth of Puerto Rico.
    (e) It is the responsibility of the Food and Drug Administration, 
subject to review by Federal courts, to determine whether a State or 
local requirement is equal to, or substantially identical to, 
requirements imposed by or under the act, or is different from, or in 
addition to, such requirements, in accordance with the procedures 
provided by this part. However, it is the responsibility of States and 
political subdivisions to determine initially whether to seek exemptions 
from preemption. Any State or political subdivision whose requirements 
relating to devices are preempted by section 521(a) may petition the 
Commissioner of Food and Drugs for exemption from preemption, in 
accordance with the procedures provided by this part.
    (f) The Federal requirement with respect to a device applies whether 
or not a corresponding State or local requirement is preempted or 
exempted from preemption. As a result, if a State or local requirement 
that the Food and Drug Administration has exempted from preemption is 
not as broad in its application as the Federal requirement, the Federal 
requirement applies to all circumstances not covered by the State or 
local requirement.

[43 FR 18665, May 2, 1978, as amended at 45 FR 67336, Oct. 10, 1980; 61 
FR 52654, Oct. 7, 1996]



Sec. 808.3  Definitions.

    (a) Act means the Federal Food, Drug, and Cosmetic Act.
    (b) Compelling local conditions includes any factors, 
considerations, or circumstances prevailing in, or characteristic of, 
the geographic area or population of the State or political subdivision 
that justify exemption from preemption.
    (c) More stringent refers to a requirement of greater 
restrictiveness or one that is expected to afford to those who may be 
exposed to a risk of injury from a device a higher degree of protection 
than is afforded by a requirement applicable to the device under the 
act.
    (d) Political subdivision or locality means any lawfully established 
local governmental unit within a State which unit has the authority to 
establish or continue in effect any requirement having the force and 
effect of law with respect to a device intended for human use.
    (e) State means a State, American Samoa, the Canal Zone, the 
Commonwealth of Puerto Rico, the District of Columbia, Guam, Johnston 
Island, Kingman Reef, Midway Island, the Trust Territory of the Pacific 
Islands, the Virgin Islands, and Wake Island.
    (f) Substantially identical to refers to the fact that a State or 
local requirement does not significantly differ in effect from a Federal 
requirement.



Sec. 808.5  Advisory opinions.

    (a) Any State, political subdivision, or other interested person may 
request an advisory opinion from the Commissioner with respect to any 
general matter concerning preemption of State or local device 
requirements or with respect to whether the Food and Drug Administration 
regards particular State or local requirements, or proposed 
requirements, as preempted.

[[Page 77]]

    (1) Such an advisory opinion may be requested and may be granted in 
accordance with Sec. 10.85 of this chapter.
    (2) The Food and Drug Administration, in its discretion and after 
consultation with the State or political subdivision, may treat a 
request by a State or political subdivision for an advisory opinion as 
an application for exemption from preemption under Sec. 808.20.
    (b) The Commissioner may issue an advisory opinion relating to a 
State or local requirement on his own initiative when he makes one of 
the following determinations:
    (1) A requirement with respect to a device for which an application 
for exemption from preemption has been submitted under Sec. 808.20 is 
not preempted by section 521(a) of the act because it is: (i) Equal to 
or substantially identical to a requirement under the act applicable to 
the device, or (ii) is not a requirement within the meaning of section 
521 of the act and therefore is not preempted;
    (2) A proposed State or local requirement with respect to a device 
is not eligible for exemption from preemption because the State or local 
requirement has not been issued in final form. In such a case, the 
advisory opinion may indicate whether the proposed requirement would be 
preempted and, if it would be preempted, whether the Food and Drug 
Administration would propose to grant an exemption from preemption;
    (3) Issuance of such an advisory opinion is in the public interest.



                     Subpart B--Exemption Procedures



Sec. 808.20  Application.

    (a) Any State or political subdivision may apply to the Food and 
Drug Administration for an exemption from preemption for any requirement 
that it has enacted and that is preempted. An exemption may only be 
granted for a requirement that has been enacted, promulgated, or issued 
in final form by the authorized body or official of the State or 
political subdivision so as to have the force and effect of law. 
However, an application for exemption may be submitted before the 
effective date of the requirement.
    (b) An application for exemption shall be in the form of a letter to 
the Commissioner of Food and Drugs and shall be signed by an individual 
who is authorized to request the exemption on behalf of the State or 
political subdivision. An original and two copies of the letter and any 
accompanying material, as well as any subsequent reports or 
correspondence concerning an application, shall be submitted to the 
Dockets Management Branch (HFA-305), Food and Drug Administration, rm. 
1-23, 12420 Parklawn Dr. Rockville, MD 20857. The outside wrapper of any 
application, report, or correspondence should indicate that it concerns 
an application for exemption from preemption of device requirements.
    (c) For each requirement for which an exemption is sought, the 
application shall include the following information to the fullest 
extent possible, or an explanation of why such information has not been 
included:
    (1) Identification and a current copy of any statute, rule, 
regulation, or ordinance of the State or political subdivision 
considered by the State or political subdivision to be a requirement 
which is preempted, with a reference to the date of enactment, 
promulgation, or issuance in final form. The application shall also 
include, where available, copies of any legislative history or 
background materials pertinent to enactment, promulgation, or issuance 
of the requirement, including hearing reports or studies concerning 
development or consideration of the requirement. If the requirement has 
been subject to any judicial or administrative interpretations, the 
State or political subdivision shall furnish copies of such judicial or 
administrative interpretations.
    (2) A comparison of the requirement of the State or political 
subdivision and any applicable Federal requirements to show similarities 
and differences.
    (3) Information on the nature of the problem addressed by the 
requirement of the State or political subdivision.
    (4) Identification of which (or both) of the following bases is 
relied upon for seeking an exemption from preemption:

[[Page 78]]

    (i) The requirement is more stringent than a requirement applicable 
to a device under the act. If the State or political subdivision relies 
upon this basis for exemption from preemption, the application shall 
include information, data, or material showing how and why the 
requirement of the State or political subdivision is more stringent than 
requirements under the act.
    (ii) The requirement is required by compelling local conditions, and 
compliance with the requirement would not cause the device to be in 
violation of any applicable requirement under the act. If the State or 
political subdivision relies upon this basis for exemption from 
preemption, the application shall include information, data, or material 
showing why compliance with the requirement of the State or political 
subdivision would not cause a device to be in violation of any 
applicable requirement under the act and why the requirement is required 
by compelling local conditions. The application shall also explain in 
detail the compelling local conditions that justify the requirement.
    (5) The title of the chief administrative or legal officers of that 
State or local agency that has primary responsibility for administration 
of the requirement.
    (6) When requested by the Food and Drug Administration, any records 
concerning administration of any requirement which is the subject of an 
exemption or an application for an exemption from preemption.
    (7) Information on how the public health may be benefitted and how 
interstate commerce may be affected, if an exemption is granted.
    (8) Any other pertinent information respecting the requirement 
voluntarily submitted by the applicant.
    (d) If litigation regarding applicability of the requirement is 
pending, the State or political subdivision may so indicate in its 
application and request expedited action on such application.

[43 FR 18665, May 2, 1978; 43 FR 22010, May 23, 1978, as amended at 49 
FR 3646, Jan. 30, 1984; 59 FR 14365, Mar. 28, 1994]



Sec. 808.25  Procedures for processing an application.

    (a) Upon receipt of an application for an exemption from preemption 
submitted in accordance with Sec. 808.20, the Commissioner shall notify 
the State or political subdivision of the date of such receipt.
    (b) If the Commissioner finds that an application does not meet the 
requirements of Sec. 808.20, he shall notify the State or political 
subdivision of the deficiencies in the application and of the 
opportunity to correct such deficiencies. A deficient application may be 
corrected at any time.
    (c) After receipt of an application meeting the requirements of 
Sec. 808.20, the Commissioner shall review such application and 
determine whether to grant or deny an exemption from preemption for each 
requirement which is the subject of the application. The Commissioner 
shall then issue in the Federal Register a proposed regulation either to 
grant or to deny an exemption from preemption. The Commissioner shall 
also issue in the Federal Register a notice of opportunity to request an 
oral hearing before the Commissioner or the Commissioner's designee.
    (d) A request for an oral hearing may be made by the State or 
political subdivision or any other interested person. Such request shall 
be submitted to the Dockets Management Branch within the period of time 
prescribed in the notice and shall include an explanation of why an oral 
hearing, rather than submission of written comments only, is essential 
to the presentation of views on the application for exemption from 
preemption and the proposed regulation.
    (e) If a timely request for an oral hearing is made, the 
Commissioner shall review such a request and may grant a legislative-
type informal oral hearing pursuant to part 15 of this chapter by 
publishing in the Federal Register a notice of the hearing in accordance 
with Sec. 15.20 of this chapter. The scope of the oral hearing shall be 
limited to matters relevant to the application for exemption from 
preemption and the proposed regulation. Oral or written presentations at 
the oral hearing which are not relevant to the

[[Page 79]]

application shall be excluded from the administrative record of the 
hearing.
    (f) If a request for hearing is not timely made or a notice of 
appearance is not filed pursuant to Sec. 15.21 of this chapter, the 
Commissioner shall consider all written comments submitted and publish a 
final rule in accordance with paragraph (g) of this section.
    (g)(1) The Commissioner shall review all written comments submitted 
on the proposed rule and the administrative record of the oral hearing, 
if an oral hearing has been granted, and shall publish in the Federal 
Register a final rule in subpart C of this part identifying any 
requirement in the application for which exemption from preemption is 
granted, or conditionally granted, and any requirement in the 
application for which exemption from preemption is not granted.
    (2) The Commissioner may issue a regulation granting or 
conditionally granting an application for an exemption from preemption 
for any requirement if the Commissioner makes either of the following 
findings:
    (i) The requirement is more stringent than a requirement applicable 
to the device under the act;
    (ii) The requirement is required by compelling local conditions, and 
compliance with the requirement would not cause the device to be in 
violation of any requirement applicable to the device under the act.
    (3) The Commissioner may not grant an application for an exemption 
from preemption for any requirement with respect to a device if the 
Commissioner determines that the granting of an exemption would not be 
in the best interest of public health, taking into account the potential 
burden on interstate commerce.
    (h) An advisory opinion pursuant to Sec. 808.5 or a regulation 
pursuant to paragraph (g) of this section constitutes final agency 
action.



Sec. 808.35  Revocation of an exemption.

    (a) An exemption from preemption pursuant to a regulation under this 
part shall remain effective until the Commissioner revokes such 
exemption.
    (b) The Commissioner may by regulation, in accordance with 
Sec. 808.25, revoke an exemption from preemption for any of the 
following reasons:
    (1) An exemption may be revoked upon the effective date of a newly 
established requirement under the act which, in the Commissioner's view, 
addresses the objectives of an exempt requirement and which is 
described, when issued, as preempting a previously exempt State or local 
requirement.
    (2) An exemption may be revoked upon a finding that there has 
occurred a change in the bases listed in Sec. 808.20(c)(4) upon which 
the exemption was granted.
    (3) An exemption may be revoked if it is determined that a condition 
placed on the exemption by the regulation under which the exemption was 
granted has not been met or is no longer being met.
    (4) An exemption may be revoked if a State or local jurisdiction 
fails to submit records as provided in Sec. 808.20(c)(6).
    (5) An exemption may be revoked if a State or local jurisdiction to 
whom the exemption was originally granted requests revocation.
    (6) An exemption may be revoked if it is determined that it is no 
longer in the best interests of the public health to continue the 
exemption.
    (c) An exemption that has been revoked may be reinstated, upon 
request from the State or political subdivision, if the Commissioner, in 
accordance with the procedures in Sec. 808.25, determines that the 
grounds for revocation are no longer applicable except that the 
Commissioner may permit abbreviated submissions of the documents and 
materials normally required for an application for exemption under 
Sec. 808.20.



        Subpart C--Listing of Specific State and Local Exemptions



Sec. 808.51  Alabama.

    To the extent that the age restriction on the sale, barter, and 
exchange of cigarettes and smokeless tobacco found in Alabama Code, 
section 13A-12-3, is preempted under section 521(a) of

[[Page 80]]

the act, the Food and Drug Administration has exempted it from 
preemption under section 521(b) of the act.

[62 FR 63274, Nov. 28, 1997]



Sec. 808.52  Alaska.

    To the extent that the age restriction on the sale and exchange of 
cigarettes and smokeless tobacco found in Alaska Statutes, sections 
11.76.100(a), is preempted under section 521(a) of the act, the Food and 
Drug Administration has exempted it from preemption under section 521(b) 
of the act.

[62 FR 63274, Nov. 28, 1997]



Sec. 808.53  Arizona.

    The following Arizona medical device requirements are preempted by 
section 521(a) of the act, and the Food and Drug Administration has 
denied them exemptions from preemption under section 521(b) of the act:
    (a) Arizona Revised Statutes, Chapter 17, sections 36-1901.7(s) and 
36-1901.7(t).
    (b) Arizona Code of Revised Regulations, Title 9, Article 3, 
sections R9-16-303 and R9-16-304.

[45 FR 67336, Oct. 10, 1980]



Sec. 808.55  California.

    (a) The following California medical device requirements are 
enforceable notwithstanding section 521 of the act because the Food and 
Drug Administration exempted them from preemption under section 521(b) 
of the act: Business and Professions Code sections 3365 and 3365.6.
    (b) The following California medical device requirements are 
preempted by section 521 of the act, and FDA has denied them an 
exemption from preemption:
    (1) Sherman Food, Drug, and Cosmetic Law (Division 21 of the 
California Health and Safety Code), sections 26207, 26607, 26614, 26615, 
26618, 26631, 26640, and 26641, to the extent that they apply to 
devices.
    (2) Sherman Food, Drug, and Cosmetic Law, section 26463(m) to the 
extent that it applies to hearing aids.
    (3) Business and Professions Code section 2541.3, to the extent that 
it requires adoption of American National Standards Institute standards 
Z-80.1 and Z-80.2.

[45 FR 67324, Oct. 10, 1980]



Sec. 808.57  Connecticut.

    The following Connecticut medical device requirements are 
enforceable notwithstanding section 521(a) of the act because the Food 
and Drug Administration has exempted them from preemption under section 
521(b) of the act: Connecticut General Statutes, sections 20-403 and 20-
404.

[45 FR 67336, Oct. 10, 1980]



Sec. 808.59  Florida.

    The following Florida medical device requirements are preempted by 
section 521(a) of the act, and the Food and Drug Administration has 
denied them an exemption from preemption under section 521(b) of the 
act:
    (a) Florida Statutes, section 468.135(5).
    (b) Florida Administrative Code, section 10D-48.25(26).

[45 FR 67336, Oct. 10, 1980]



Sec. 808.61  Hawaii.

    (a) The following Hawaii medical device requirements are enforceable 
notwithstanding section 521 of the act, because the Food and Drug 
Administration has exempted them from preemption under section 521(b) of 
the act: Hawaii Revised Statutes, chapter 451A, Sec. 14.1, subsection 
(a) with respect to medical examination of a child 10 years of age or 
under, and subsection (c).
    (b) The following Hawaii medical device requirements are preempted 
by section 521(a) of the act, and the Food and Drug Administration has 
denied them exemption from preemption: Hawaii Revised Statutes, chapter 
451A, Sec. 14.1, subsection (a) to the extent that it requires a written 
authorization by a physician and does not allow adults to waive this 
requirement for personal, as well as religious reasons, and subsection 
(b).

[50 FR 30699, July 29, 1985; 50 FR 32694, Aug. 14, 1985]

[[Page 81]]



Sec. 808.67  Kentucky.

    The following Kentucky medical device requirement is preempted by 
section 521(a) of the act, and the Food and Drug Administration has 
denied it an exemption from preemption under section 521(b) of the act: 
Kentucky Revised Statutes, section 334.200(1).

[45 FR 67336, Oct. 10, 1980]



Sec. 808.69  Maine.

    (a) The following Maine medical device requirement is enforceable 
notwithstanding section 521(a) of the act because the Food and Drug 
Administration has exempted it from preemption under section 521(b) of 
the act: Maine Revised Statutes Annotated, Title 32, section 1658-C, on 
the condition that, in enforcing this requirement, Maine apply the 
definition of ``used hearing aid'' in Sec. 801.420(a)(6) of this 
chapter.
    (b) The following Maine medical device requirement is preempted by 
section 521(a) of the act, and the Food and Drug Administration has 
denied it an exemption from preemption under section 521(b) of the act: 
Maine Revised Statutes Annotated, Title 32, section 1658-D and the last 
sentence of section 1658-E.

[45 FR 67336, Oct. 10, 1980]



Sec. 808.71  Massachusetts.

    (a) The following Massachusetts medical device requirements are 
enforceable notwithstanding section 521 of the act because the Food and 
Drug Administration has exempted them from preemption under section 
521(b) of the act:
    (1) Massachusetts General Laws, Chapter 93, Section 72, to the 
extent that it requires a hearing test evaluation for a child under the 
age of 18.
    (2) Massachusetts General Laws, Chapter 93, Section 74, except as 
provided in paragraph (6) of the Section, on the condition that, in 
enforcing this requirement, Massachusetts apply the definition of ``used 
hearing aid'' in Sec. 801.420(a)(6) of this chapter.
    (b) The following Massachusetts medical device requirements are 
preempted by section 521(a) of the act, and the Food and Drug 
Administration has denied them exemptions from preemption under section 
521(b) of the act.
    (1) Massachusetts General Laws, Chapter 93, Section 72, except as 
provided in paragraph (a) of this section.
    (2) Massachusetts General Laws, Chapter 93, Section 74, to the 
extent that it requires that the sales receipt contain a statement that 
State law requires a medical examination and a hearing test evaluation 
before the sale of a hearing aid.

[45 FR 67326, Oct. 10, 1980]



Sec. 808.73  Minnesota.

    The following Minnesota medical device requirements are preempted by 
section 521(a) of the act, and the Food and Drug Administration has 
denied them an exemption from preemption under section 521(b) of the 
act: Minnesota Statutes, sections 145.43 and 145.44.

[45 FR 67336, Oct. 10, 1980]



Sec. 808.74  Mississippi.

    The following Mississippi medical device requirement is preempted by 
section 521(a) of the act, and the Food and Drug Administration has 
denied it an exemption from preemption under section 521(b) of the act: 
Mississippi Code, section 73-14-3(g)(9).

[45 FR 67336, Oct. 10, 1980]



Sec. 808.77  Nebraska.

    (a) The following Nebraska medical device requirement is enforceable 
notwithstanding section 521(a) of the act because the Food and Drug 
Administration has exempted it from preemption under section 521(b) of 
the act: Nebraska Revised Statutes, section 71-4712(2)(c)(vi).
    (b) The following Nebraska medical device requirement is preempted 
by section 521(a) of the act, and the Food and Drug Administration has 
denied it an exemption from preemption under section 521(b) of the act: 
Nebraska Revised Statutes, section 71-4712(2)(c)(vii).

[45 FR 67336, Oct. 10, 1980]



Sec. 808.80  New Jersey.

    (a) The following New Jersey medical device requirements are 
enforceable notwithstanding section 521(a) of the

[[Page 82]]

act because the Food and Drug Administration has exempted them from 
preemption under section 521(b) of the act:
    (1) New Jersey Statutes Annotated, section 45:9A-23 on the condition 
that, in enforcing this requirement, New Jersey apply the definition of 
``used hearing aid'' in Sec. 801.420(a)(6) of this chapter;
    (2) New Jersey Statutes Annotated, sections 45:9A-24 and 45:9A-25;
    (3) Chapter 3, Section 5 of the Rules and Regulations adopted 
pursuant to New Jersey Statutes Annotated 45:9A-1 et seq. except as 
provided in paragraph (b) of this section.
    (b) The following New Jersey medical device requirement is preempted 
by section 521(a) of the act, and the Food and Drug Administration has 
denied it an exemption from preemption under section 521(b) of the act: 
Chapter 3, Section 5 of the Rules and Regulations adopted pursuant to 
New Jersey Statutes Annotated 45:9A-1 et seq. to the extent that it 
requires testing to be conducted in an environment which meets or 
exceeds the American National Standards Institute S3.1 Standard.

[45 FR 67337, Oct. 10, 1980]



Sec. 808.81  New Mexico.

    The following New Mexico medical device requirement is enforceable 
notwithstanding section 521(a) of the act because the Food and Drug 
Administration has exempted it from preemption under section 521(b) of 
the act: New Mexico Statutes Annotated, section 67-36-16(F).

[45 FR 67337, Oct. 10, 1980]



Sec. 808.82  New York.

    (a) The following New York medical device requirements are 
enforceable notwithstanding section 521(a) of the act because the Food 
and Drug Administration has exempted them from preemption under section 
521(b) of the act:
    (1) General Business Law, Article 37, sections 784(3) and (4).
    (2) Official Compilation of Codes, Rules and Regulations of the 
State of New York, Chapter V, Title 19, Subchapter G, section 191.10 and 
section 191.11(a) on the condition that, in enforcing these 
requirements, New York apply the definition of ``used hearing aid'' in 
Sec. 801.420(a)(6) of this chapter and section 191.11(b), (c), (d), and 
(e).
    (b) The following New York medical device requirements are preempted 
by section 521(a) of the act, and the Food and Drug Administration has 
denied them an exemptions from preemption under section 521(b) of the 
act:
    (1) General Business Law, Article 37, section 784.1.
    (2) Official Compilation of Codes, Rules and Regulations of the 
State of New York, Chapter V, Title 19, Subchapter G, sections 191.6, 
191.7, 191.8, and 191.9.

[45 FR 67337, Oct. 10, 1980]



Sec. 808.85  Ohio.

    (a) The following Ohio medical device requirement is enforceable 
notwithstanding section 521(a) of the act because the Food and Drug 
Administration has exempted it from preemption under section 521(b) of 
the act: Ohio Revised Code, section 4747.09, the first two sentences 
with respect to disclosure of information to purchasers on the condition 
that, in enforcing these requirements, Ohio apply the definition of 
``used hearing aid'' in Sec. 801.420(a)(6) of this chapter.
    (b) The following Ohio medical device requirement is preempted by 
section 521(a) of the act, and the Food and Drug Administration has 
denied it an exemption from preemption under section 521(b) of the act: 
Ohio Revised Code, section 4747.09, the last two sentences with respect 
to medical examination of children.

[45 FR 67337, Oct. 10, 1980]



Sec. 808.87  Oregon.

    (a) The following Oregon medical device requriements are enforceable 
notwithstanding section 521(a) of the act because the Food and Drug 
Administration has exempted them from preemption under section 521(b) of 
the act: Oregon Revised Statutes, section 694.036 on the condition that, 
in enforcing this requirement, Oregon apply the definition of ``used 
hearing aid'' in Sec. 801.420(a)(6) of this chapter.
    (b) The following Oregon medical device requirements are preempted 
by section 521(a) of the act, and the Food and Drug Administration has 
denied

[[Page 83]]

them exemptions from preemption under section 521(b) of the act: Oregon 
Revised Statutes, sections 694.136(6) and (7).

[45 FR 67337, Oct. 10, 1980, as amended at 53 FR 11252, Apr. 6, 1988]



Sec. 808.88  Pennsylvania.

    (a) The following Pennsylvania medical device requirements are 
enforceable notwithstanding section 521(a) of the act because the Food 
and Drug Administration has exempted them from preemption under section 
521(b) of the act: 35 Purdon's Statutes 6700, section 504(4) on the 
condition that, in enforcing this requirement, Pennsylvania apply the 
definition of ``used hearing aid'' in Sec. 801.420(a)(6) of this 
chapter; section 506; and, section 507(2).
    (b) The following Pennsylvania medical device requirement is 
preempted by section 521(a) of the act and the Food and Drug 
Administration has denied it an exemption from preemption under section 
521(b) of the act: 35 Purdon's Statutes 6700, section 402.

[45 FR 67326, Oct. 10, 1980]



Sec. 808.89  Rhode Island.

    The following Rhode Island medical device requirements are preempted 
by section 521(a) of the act, and the Food and Drug Administration has 
denied them an exemption from preemption under section 521(b) of the 
act: Rhode Island General Laws, Section 5-49-2.1, and Section 2.2, to 
the extent that Section 2.2 requires hearing aid dispensers to keep 
copies of the certificates of need.

[45 FR 67337, Oct. 10, 1980]



Sec. 808.93  Texas.

    (a) The following Texas medical device requirement is enforceable 
notwithstanding section 521(a) of the act because the Food and Drug 
Administration has exempted it from preemption under section 521(b) of 
the act: Vernon's Civil Statutes, Article 4566, section 14(b) on the 
condition that, in enforcing this requirement, Texas apply the 
definition of ``used hearing aid'' in Sec. 801.420(a)(6) of this 
chapter.
    (b) The following Texas medical device requirement is preempted by 
section 521(a) of the act, and the Food and Drug Administration has 
denied it an exemption from preemption under section 521(b) of the act: 
Vernon's Civil Statutes, Article 4566, section 14(d).

[45 FR 67337, Oct. 10, 1980]



Sec. 808.94  Utah.

    To the extent that the age restriction on sales of cigarettes and 
smokeless tobacco found in the Utah Code Annotated, section 76-10-104, 
is preempted under section 521(a) of the act, the Food and Drug 
Administration has exempted it from preemption under section 521(b) of 
the act.

[62 FR 63274, Nov. 28, 1997]



Sec. 808.97  Washington.

    (a) The following Washington medical device requirement is 
enforceable notwithstanding section 521(a) of the act because the Food 
and Drug Administration has exempted it from preemption under section 
521(b) of the act: Revised Code of Washington 18.35.110(2)(e) (i) and 
(iii) on the condition that it is enforced in addition to the applicable 
requirements of this chapter.
    (b) The following Washington medical device requirements are 
preempted by section 521(a) of the act, and the Food and Drug 
Administration has denied them an exemption from preemption under 
section 521(b) of the act: Revised Code of Washington 
18.35.110(2)(e)(ii).

[45 FR 67337, Oct. 10, 1980]



Sec. 808.98  West Virginia.

    (a) The following West Virginia medical device requirements are 
enforceable notwithstanding section 521(a) of the act because the Food 
and Drug Administration has exempted them from preemption: West Virginia 
Code, sections 30-26-14 (b) and (c) and section 30-26-15(a) on the 
condition that in enforcing section 30-26-15(a) West Virginia apply the 
definition of ``used hearing aid'' in Sec. 801.420(a)(6) of this 
chapter.
    (b) The following West Virginia medical device requirement is 
preempted by section 521(a) of the act, and the Food and Drug 
Administration has denied it an exemption from preemption

[[Page 84]]

under section 521(b) of the act: West Virginia Code, section 30-26-
14(a).

[45 FR 67337, Oct. 10, 1980, as amended at 53 FR 35314, Sept. 13, 1988]



Sec. 808.101  District of Columbia.

    (a) The following District of Columbia medical device requirements 
are enforceable, notwithstanding section 521 of the act, because the 
Food and Drug Administration has exempted them from preemption under 
section 521(b) of the act:
    (1) Act 2-79, section 5, to the extent that it requires an 
audiological evaluation for children under the age of 18.
    (2) Act 2-79, section 6, on the condition that in enforcing section 
6(a)(5), the District of Columbia apply the definition of ``used hearing 
aid'' in Sec. 801.420(a)(6) of this chapter.
    (b) The following District of Columbia medical device requirement is 
preempted by section 521(a) of the act, and the Food and Drug 
Administration has denied it an exemption from preemption under section 
521(b) of the act: Act 2-79, section 5, except as provided in paragraph 
(a) of this section.

[46 FR 59236, Dec. 4, 1981]



PART 809--IN VITRO DIAGNOSTIC PRODUCTS FOR HUMAN USE--Table of Contents




                      Subpart A--General Provisions

Sec.
809.3  Definitions.
809.4  Confidentiality of submitted information.

                           Subpart B--Labeling

809.10  Labeling for in vitro diagnostic products.

         Subpart C--Requirements for Manufacturers and Producers

809.20  General requirements for manufacturers and producers of in vitro 
          diagnostic products.
809.30  Restrictions on the sale, distribution and use of analyte 
          specific reagents.

    Authority:  21 U.S.C. 331, 351, 352, 355, 360b, 360c, 360d, 360h, 
360i, 360j, 371, 372, 374, 381.



                      Subpart A--General Provisions



Sec. 809.3  Definitions.

    (a) In vitro diagnostic products are those reagents, instruments, 
and systems intended for use in the diagnosis of disease or other 
conditions, including a determination of the state of health, in order 
to cure, mitigate, treat, or prevent disease or its sequelae. Such 
products are intended for use in the collection, preparation, and 
examination of specimens taken from the human body. These products are 
devices as defined in section 201(h) of the Federal Food, Drug, and 
Cosmetic Act (the act), and may also be biological products subject to 
section 351 of the Public Health Service Act.
    (b) A product class is all those products intended for use for a 
particular determination or for a related group of determinations or 
products with common or related characteristics or those intended for 
common or related uses. A class may be further divided into subclasses 
when appropriate.
    (c) [Reserved]
    (d) Act means the Federal Food, Drug, and Cosmetic Act.

[41 FR 6903, Feb. 13, 1976, as amended at 45 FR 7484, Feb. 1, 1980]



Sec. 809.4  Confidentiality of submitted information.

    Data and information submitted under Sec. 809.10(c) that are shown 
to fall within the exemption established in Sec. 20.61 of this chapter 
shall be treated as confidential by the Food and Drug Administration and 
any person to whom the data and information are referred. The Food and 
Drug Administration will determine whether information submitted will be 
treated as confidential in accordance with the provisions of part 20 of 
this chapter.

[45 FR 7484, Feb. 1, 1980]



                           Subpart B--Labeling



Sec. 809.10  Labeling for in vitro diagnostic products.

    (a) The label for an in vitro diagnostic product shall state the 
following

[[Page 85]]

information, except where such information is not applicable, or as 
otherwise specified in a standard for a particular product class or as 
provided in paragraph (e) of this section. Section 201(k) of the act 
provides that ``a requirement made by or under authority of this act 
that any word, statement, or other information appear on the label shall 
not be considered to be complied with unless such word, statement, or 
other information also appears on the outside container or wrapper, if 
any there be, of the retail package of such article, or is easily 
legible through the outside container or wrapper.''
    (1) The proprietary name and established name (common or usual 
name), if any.
    (2) The intended use or uses of the product.
    (3) For a reagent, a declaration of the established name (common or 
usual name), if any, and quantity, proportion or concentration of each 
reactive ingredient; and for a reagent derived from biological material, 
the source and a measure of its activity. The quantity, proportion, 
concentration, or activity shall be stated in the system generally used 
and recognized by the intended user, e.g., metric, international units, 
etc.
    (4) A statement of warnings or precautions for users as established 
in the regulations contained in 16 CFR part 1500 and any other warnings 
appropriate to the hazard presented by the product; and a statement 
``For In Vitro Diagnostic Use'' and any other limiting statements 
appropriate to the intended use of the product.
    (5) For a reagent, appropriate storage instructions adequate to 
protect the stability of the product. When applicable, these 
instructions shall include such information as conditions of 
temperature, light, humidity, and other pertinent factors. For products 
requiring manipulation, such as reconstitution and/or mixing before use, 
appropriate storage instructions shall be provided for the reconstituted 
or mixed product which is to be stored in the original container. The 
basis for such instructions shall be determined by reliable, meaningful, 
and specific test methods such as those described in Sec. 211.166 of 
this chapter.
    (6) For a reagent, a means by which the user may be assured that the 
product meets appropriate standards of identity, strength, quality and 
purity at the time of use. This shall be provided, both for the product 
as provided and for any resultant reconstituted or mixed product, by 
including on the label one or more of the following:
    (i) An expiration date based upon the stated storage instructions.
    (ii) A statement of an observable indication of an alteration of the 
product, e.g., turbidity, color change, precipitate, beyond its 
appropriate standards.
    (iii) Instructions for a simple method by which the user can 
reasonably determine that the product meets its appropriate standards.
    (7) For a reagent, a declaration of the net quantity of contents, 
expressed in terms of weight or volume, numerical count, or any 
combination of these or other terms which accurately reflect the 
contents of the package. The use of metric designations is encouraged, 
wherever appropriate. If more than a single determination may be 
performed using the product, any statement of the number of tests shall 
be consistent with instructions for use and amount of material provided.
    (8) Name and place of business of manufacturer, packer, or 
distributor.
    (9) A lot or control number, identified as such, from which it is 
possible to determine the complete manufacturing history of the product.
    (i) If it is a multiple unit product, the lot or control number 
shall permit tracing the identity of the individual units.
    (ii) For an instrument, the lot or control number shall permit 
tracing the identity of all functional subassemblies.
    (iii) For multiple unit products which require the use of included 
units together as a system, all units should bear the same lot or 
control number, if appropriate, or other suitable uniform identification 
should be used.
    (10) Except that for items in paragraphs (a) (1) through (9) of this 
section: (i) In the case of immediate containers too small or otherwise 
unable

[[Page 86]]

to accommodate a label with sufficient space to bear all such 
information and which are packaged within an outer container from which 
they are removed for use, the information required by paragraphs (a) 
(2), (3), (4), (5), (6) (ii), (iii) and (7) of this section may appear 
in the outer container labeling only.
    (ii) In any case in which the presence of this information on the 
immediate container will interfere with the test, the information may 
appear on the outside container or wrapper rather than on the immediate 
container label.
    (b) Labeling accompanying each product, e.g., a package insert, 
shall state in one place the following information in the format and 
order specified below, except where such information is not applicable, 
or as specified in a standard for a particular product class. The 
labeling for a multiple-purpose instrument used for diagnostic purposes, 
and not committed to specific diagnostic procedures or systems, may bear 
only the information indicated in paragraphs (b) (1), (2), (6), (14), 
and (15) of this section. The labeling for a reagent intended for use as 
a replacement in a diagnostic system may be limited to that information 
necessary to identify the reagent adequately and to describe its proper 
use in the system.
    (1) The proprietary name and established name, i.e., common or usual 
name, if any.
    (2) The intended use or uses of the product and the type of 
procedure, e.g., qualitative or quantitative.
    (3) Summary and explanation of the test. Include a short history of 
the methodology, with pertinent references and a balanced statement of 
the special merits and limitations of this method or product. If the 
product labeling refers to any other procedure, appropriate literature 
citations shall be included and the labeling shall explain the nature of 
any differences from the original and their effect on the results.
    (4) The chemical, physical, physiological, or biological principles 
of the procedure. Explain concisely, with chemical reactions and 
techniques involved, if applicable.
    (5) Reagents:
    (i) A declaration of the established name (common or usual name), if 
any, and quantity, proportion or concentration or each reactive 
ingredient; and for biological material, the source and a measure of its 
activity. The quantity, proportion, concentration or activity shall be 
stated in the system generally used and recognized by the intended user, 
e.g., metric, international units, etc. A statement indicating the 
presence of and characterizing any catalytic or nonreactive ingredients, 
e.g., buffers, preservatives, stabilizers.
    (ii) A statement of warnings or precautions for users as established 
in the regulations contained in 16 CFR part 1500 and any other warnings 
appropriate to the hazard presented by the product; and a statement 
``For In Vitro Diagnostic Use'' and any other limiting statements 
appropriate to the intended use of the product.
    (iii) Adequate instructions for reconstitution, mixing, dilution, 
etc.
    (iv) Appropriate storage instructions adequate to protect the 
stability of the product. When applicable, these instructions shall 
include such information as conditions of temperature, light, humidity, 
and other pertinent factors. For products requiring manipulation, such 
as reconstitution and/or mixing before use, appropriate storage 
instructions shall be provided for the reconstituted or mixed product. 
The basis for such instructions shall be determined by reliable, 
meaningful, and specific test methods such as those described in 
Sec. 211.166 of this chapter.
    (v) A statement of any purification or treatment required for use.
    (vi) Physical, biological, or chemical indications of instability or 
deterioration.
    (6) Instruments:
    (i) Use or function.
    (ii) Installation procedures and special requirements.
    (iii) Principles of operation.
    (iv) Performance characteristics and specifications.
    (v) Operating instructions.
    (vi) Calibration procedures including materials and/or equipment to 
be used.
    (vii) Operational precautions and limitations.
    (viii) Hazards.
    (ix) Service and maintenance information.

[[Page 87]]

    (7) Specimen collection and preparation for analysis, including a 
description of:
    (i) Special precautions regarding specimen collection including 
special preparation of the patient as it bears on the validity of the 
test.
    (ii) Additives, preservatives, etc., necessary to maintain the 
integrity of the specimen.
    (iii) Known interfering substances.
    (iv) Recommended storage, handling or shipping instructions for the 
protection and maintenance of stability of the specimen.
    (8) Procedure: A step-by-step outline of recommended procedures from 
reception of the specimen to obtaining results. List any points that may 
be useful in improving precision and accuracy.
    (i) A list of all materials provided, e.g., reagents, instruments 
and equipment, with instructions for their use.
    (ii) A list of all materials required but not provided. Include such 
details as sizes, numbers, types, and quality.
    (iii) A description of the amounts of reagents necessary, times 
required for specific steps, proper temperatures, wavelengths, etc.
    (iv) A statement describing the stability of the final reaction 
material to be measured and the time within which it shall be measured 
to assure accurate results.
    (v) Details of calibration: Identify reference material. Describe 
preparation of reference sample(s), use of blanks, preparation of the 
standard curve, etc. The description of the range of calibration should 
include the highest and the lowest values measurable by the procedure.
    (vi) Details of kinds of quality control procedures and materials 
required. If there is need for both positive and negative controls, this 
should be stated. State what are considered satisfactory limits of 
performance.
    (9) Results: Explain the procedure for calculating the value of the 
unknown. Give an explanation for each component of the formula used for 
the calculation of the unknown. Include a sample calculation, step-by-
step, explaining the answer. The values shall be expressed to the 
appropriate number of significant figures. If the test provides other 
than quantitative results, provide an adequate description of expected 
results.
    (10) Limitation of the procedure: Include a statement of limitations 
of the procedure. State known extrinsic factors or interfering 
substances affecting results. If further testing, either more specific 
or more sensitive, is indicated in all cases where certain results are 
obtained, the need for the additional test shall be stated.
    (11) Expected values: State the range(s) of expected values as 
obtained with the product from studies of various populations. Indicate 
how the range(s) was established and identify the population(s) on which 
it was established.
    (12) Specific performance characteristics: Include, as appropriate, 
information describing such things as accuracy, precision, specificity, 
and sensitivity. These shall be related to a generally accepted method 
using biological specimens from normal and abnormal populations. Include 
a statement summarizing the data upon which the specific performance 
characteristics are based.
    (13) Bibliography: Include pertinent references keyed to the text.
    (14) Name and place of business of manufacturer, packer, or 
distributor.
    (15) Date of issuance of the last revision of the labeling 
identified as such.
    (c) A shipment or other delivery of an in vitro diagnostic product 
shall be exempt from the requirements of paragraphs (a) and (b) of this 
section and from a standard promulgated under part 861 provided that the 
following conditions are met:
    (1) In the case of a shipment or delivery for an investigation 
subject to part 812, if there has been compliance with part 812; or
    (2) In the case of a shipment or delivery for an investigation that 
is not subject to part 812 (see Sec. 812.2(c)), if the following 
conditions are met:
    (i) For a product in the laboratory research phase of development, 
and not represented as an effective in vitro diagnostic product, all 
labeling bears the statement, prominently placed: ``For Research Use 
Only. Not for use in diagnostic procedures.''

[[Page 88]]

    (ii) For a product being shipped or delivered for product testing 
prior to full commercial marketing (for example, for use on specimens 
derived from humans to compare the usefulness of the product with other 
products or procedures which are in current use or recognized as 
useful), all labeling bears the statement, prominently placed: ``For 
Investigational Use Only. The performance characteristics of this 
product have not been established.''
    (d) The labeling of general purpose laboratory reagents (e.g., 
hydrochloric acid) and equipment (e.g., test tubes and pipettes) whose 
uses are generally known by persons trained in their use need not bear 
the directions for use required by Sec. 809.10(a) and (b), if their 
labeling meets the requirements of this paragraph.
    (1) The label of a reagent shall bear the following information:
    (i) The proprietary name and established name (common or usual 
name), if any, of the reagent.
    (ii) A declaration of the established name (common or usual name), 
if any, and quantity, proportion or concentration of the reagent 
ingredient (e.g., hydrochloric acid: Formula weight 36.46, assay 37.9 
percent, specific gravity 1.192 at 60  deg.F); and for a reagent derived 
from biological material, the source and where applicable a measure of 
its activity. The quantity, proportion, concentration or activity shall 
be stated in the system generally used and recognized by the intended 
user, e.g., metric, international units, etc.
    (iii) A statement of the purity and quality of the reagent, 
including a quantitative declaration of any impurities present. The 
requirement for this information may be met by a statement of conformity 
with a generally recognized and generally available standard which 
contains the same information, e.g., those established by the American 
Chemical Society, U.S. Pharmacopeia, National Formulary, National 
Research Council.
    (iv) A statement of warnings or precautions for users as established 
in the regulations contained in 16 CFR part 1500 and any other warnings 
appropriate to the hazard presented by the product; and a statement 
``For Laboratory Use.''
    (v) Appropriate storage instructions adequate to protect the 
stability of the product. When applicable, these instructions shall 
include such information as conditions of temperature, light, humidity, 
and other pertinent factors. The basis for such information shall be 
determined by reliable, meaningful, and specific test methods such as 
those described in Sec. 211.166 of this chapter.
    (vi) A declaration of the net quantity of contents, expressed in 
terms of weight or volume, numerical count, or any combination of these 
or other terms which accurately reflect the contents of the package. The 
use of metric designations is encouraged, wherever appropriate.
    (vii) Name and place of business of manufacturer, packer, or 
distributor.
    (viii) A lot or control number, identified as such, from which it is 
possible to determine the complete manufacturing history of the product.
    (ix) In the case of immediate containers too small or otherwise 
unable to accommodate a label with sufficient space to bear all such 
information, and which are packaged within an outer container from which 
they are removed for use, the information required by paragraphs 
(d)(1)(ii), (iii), (iv), (v), and (vi) of this section may appear in the 
outer container labeling only.
    (2) The label of general purpose laboratory equipment, e.g., a 
beaker or a pipette, shall bear a statement adequately describing the 
product, its composition, and physical characteristics if necessary for 
its proper use.
    (e)(1) The labeling for analyte specific reagents (e.g., monoclonal 
antibodies, deoxyribonucleic acid (DNA) probes, viral antigens, ligands) 
shall bear the following information:
    (i) The proprietary name and established name (common or usual 
name), if any, of the reagent;
    (ii) A declaration of the established name (common or usual name), 
if any;
    (iii) The quantity, proportion, or concentration of the reagent 
ingredient; and for a reagent derived from biological material, the 
source and where applicable, a measure of its activity. The quantity, 
proportion, concentration, or activity shall be stated in the system 
generally used and recognized by the

[[Page 89]]

intended user, e.g., metric, international units, etc.;
    (iv) A statement of the purity and quality of the reagent, including 
a quantitative declaration of any impurities present and method of 
analysis or characterization. The requirement for this information may 
be met by a statement of conformity with a generally recognized and 
generally available standard that contains the same information, e.g., 
those established by the American Chemical Society, U.S. Pharmacopeia, 
National Formulary, and National Research Council. The labeling may also 
include information concerning chemical/molecular composition, nucleic 
acid sequence, binding affinity, cross-reactivities, and interaction 
with substances of known clinical significance;
    (v) A statement of warnings or precautions for users as established 
in the regulations contained in 16 CFR part 1500 and any other warnings 
appropriate to the hazard presented by the product;
    (vi) The date of manufacture and appropriate storage instructions 
adequate to protect the stability of the product. When applicable, these 
instructions shall include such information as conditions of 
temperature, light, humidity, date of expiration, and other pertinent 
factors. The basis for such instructions shall be determined by 
reliable, meaningful, and specific test methods, such as those described 
in Sec. 211.166 of this chapter;
    (vii) A declaration of the net quantity of contents, expressed in 
terms of weight or volume, numerical count, or any combination of these 
or other terms that accurately reflect the contents of the package. The 
use of metric designations is encouraged, wherever appropriate;
    (viii) The name and place of business of manufacturer, packer, or 
distributor;
    (ix) A lot or control number, identified as such, from which it is 
possible to determine the complete manufacturing history of the product;
    (x) For class I exempt ASR's, the statement: ``Analyte Specific 
Reagent. Analytical and performance characteristics are not 
established''; and
    (xi) For class II and III ASR's, the statement: ``Analyte Specific 
Reagent. Except as a component of the approved/cleared test (Name of 
approved/cleared test), analytical and performance characteristics of 
this ASR are not established.''
    (2) In the case of immediate containers too small or otherwise 
unable to accommodate a label with sufficient space to bear all such 
information, and which are packaged within an outer container from which 
they are removed for use, the information required by paragraphs (e)(1) 
through (e)(6) of this section may appear in the outer container 
labeling only.

[41 FR 6903, Feb. 13, 1976, as amended at 45 FR 3750, Jan. 18, 1980; 45 
FR 7484, Feb. 1, 1980; 47 FR 41107, Sept. 17, 1982; 47 FR 51109, Nov. 
12, 1982; 48 FR 34470, July 29, 1983; 62 FR 62259, Nov. 21, 1997]



         Subpart C--Requirements for Manufacturers and Producers



Sec. 809.20  General requirements for manufacturers and producers of in vitro diagnostic products.

    (a) [Reserved]
    (b) Compliance with good manufacturing practices. In vitro 
diagnostic products shall be manufactured in accordance with the good 
manufacturing practices requirements found in part 820 of this chapter.

[41 FR 6903, Feb. 13, 1976, as amended at 42 FR 42530, Aug. 23, 1977; 43 
FR 31527, July 21, 1978]



Sec. 809.30  Restrictions on the sale, distribution and use of analyte specific reagents.

    (a) Analyte specific reagents (ASR's) (Sec. 864.4020 of this 
chapter) are restricted devices under section 520(e) of the Federal 
Food, Drugs, and Cosmetic Act (the act) subject to the restrictions set 
forth in this section.
    (b) ASR's may only be sold to:
    (1) In vitro diagnostic manufacturers;
    (2) Clinical laboratories regulated under the Clinical Laboratory 
Improvement Amendments of 1988 (CLIA), as qualified to perform high 
complexity testing under 42 CFR part 493 or clinical laboratories 
regulated under VHA Directive 1106 (available from Department of 
Veterans Affairs, Veterans

[[Page 90]]

Health Administration, Washington, DC 20420); and
    (3) Organizations that use the reagents to make tests for purposes 
other than providing diagnostic information to patients and 
practitioners, e.g., forensic, academic, research, and other nonclinical 
laboratories.
    (c) ASR's must be labeled in accordance with Sec. 809.10(e).
    (d) Advertising and promotional materials for ASR's:
    (1) Shall include the identity and purity (including source and 
method of acquisition) of the analyte specific reagent and the identity 
of the analyte;
    (2) Shall include the statement for class I exempt ASR's: ``Analyte 
Specific Reagent. Analytical and performance characteristics are not 
established'';
    (3) Shall include the statement for class II or III ASR's: ``Analyte 
Specific Reagent. Except as a component of the approved/cleared test 
(name of approved/cleared test), analytical and performance 
characteristics are not established''; and
    (4) Shall not make any statement regarding analytical or clinical 
performance.
    (e) The laboratory that develops an in-house test using the ASR 
shall inform the ordering person of the test result by appending to the 
test report the statement: ``This test was developed and its performance 
characteristics determined by (Laboratory Name). It has not been cleared 
or approved by the U.S. Food and Drug Administration.'' This statement 
would not be applicable or required when test results are generated 
using the test that was cleared or approved in conjunction with review 
of the class II or III ASR.
    (f) Ordering in-house tests that are developed using analyte 
specific reagents is limited under section 520(e) of the act to 
physicians and other persons authorized by applicable State law to order 
such tests.
    (g) The restrictions in paragraphs (c) through (f) of this section 
do not apply when reagents that otherwise meet the analyte specific 
reagent definition are sold to:
    (1) In vitro diagnostic manufacturers; or
    (2) Organizations that use the reagents to make tests for purposes 
other than providing diagnostic information to patients and 
practitioners, e.g., forensic, academic, research, and other nonclinical 
laboratories.

[62 FR 62259, Nov. 21, 1997]



PART 810--MEDICAL DEVICE RECALL AUTHORITY--Table of Contents




                      Subpart A--General Provisions

Sec.
810.1  Scope.
810.2  Definitions.
810.3  Computation of time.
810.4  Service of orders.

          Subpart B--Mandatory Medical Device Recall Procedures

810.10  Cease distribution and notification order.
810.11  Regulatory hearing.
810.12  Written request for review of cease distribution and 
          notification order.
810.13  Mandatory recall order.
810.14  Cease distribution and notification or mandatory recall 
          strategy.
810.15  Communications concerning a cease distribution and notification 
          or mandatory recall order.
810.16  Cease distribution and notification or mandatory recall order 
          status reports.
810.17  Termination of a cease distribution and notification or 
          mandatory recall order.
810.18  Public notice.

    Authority: 21 U.S.C. 321, 331, 332, 333, 334, 351, 352, 360h, 371, 
374, 375.

    Source: 61 FR 59018, Nov. 20, 1996, unless otherwise noted.



                      Subpart A--General Provisions



Sec. 810.1  Scope.

    Part 810 describes the procedures that the Food and Drug 
Administration will follow in exercising its medical device recall 
authority under section 518(e) of the Federal Food, Drug, and Cosmetic 
Act.



Sec. 810.2  Definitions.

    As used in this part:
    (a) Act means the Federal Food, Drug, and Cosmetic Act.
    (b) Agency or FDA means the Food and Drug Administration.

[[Page 91]]

    (c) Cease distribution and notification strategy or mandatory recall 
strategy means a planned, specific course of action to be taken by the 
person named in a cease distribution and notification order or in a 
mandatory recall order, which addresses the extent of the notification 
or recall, the need for public warnings, and the extent of effectiveness 
checks to be conducted.
    (d) Consignee means any person or firm that has received, purchased, 
or used a device that is subject to a cease distribution and 
notification order or a mandatory recall order. Consignee does not mean 
lay individuals or patients, i.e., nonhealth professionals.
    (e) Correction means repair, modification, adjustment, relabeling, 
destruction, or inspection (including patient monitoring) of a device, 
without its physical removal from its point of use to some other 
location.
    (f) Device user facility means a hospital, ambulatory surgical 
facility, nursing home, or outpatient treatment or diagnostic facility 
that is not a physician's office.
    (g) Health professionals means practitioners, including physicians, 
nurses, pharmacists, dentists, respiratory therapists, physical 
therapists, technologists, or any other practitioners or allied health 
professionals that have a role in using a device for human use.
    (h) Reasonable probability means that it is more likely than not 
that an event will occur.
    (i) Serious, adverse health consequence means any significant 
adverse experience, including those that may be either life-threatening 
or involve permanent or long-term injuries, but excluding injuries that 
are nonlife-threatening and that are temporary and reasonably 
reversible.
    (j) Recall means the correction or removal of a device for human use 
where FDA finds that there is a reasonable probability that the device 
would cause serious, adverse health consequences or death.
    (k) Removal means the physical removal of a device from its point of 
use to some other location for repair, modification, adjustment, 
relabeling, destruction, or inspection.



Sec. 810.3  Computation of time.

    In computing any period of time prescribed or allowed by this part, 
the day of the act or event from which the designated period of time 
begins to run shall not be included. The computation of time is based 
only on working days.



Sec. 810.4  Service of orders.

    Orders issued under this part will be served in person by a 
designated employee of FDA, or by certified or registered mail or 
similar mail delivery service with a return receipt record reflecting 
receipt, to the named person or designated agent at the named person's 
or designated agent's last known address in FDA's records.



          Subpart B--Mandatory Medical Device Recall Procedures



Sec. 810.10  Cease distribution and notification order.

    (a) If, after providing the appropriate person with an opportunity 
to consult with the agency, FDA finds that there is a reasonable 
probability that a device intended for human use would cause serious, 
adverse health consequences or death, the agency may issue a cease 
distribution and notification order requiring the person named in the 
order to immediately:
    (1) Cease distribution of the device;
    (2) Notify health professionals and device user facilities of the 
order; and
    (3) Instruct these professionals and device user facilities to cease 
use of the device.
    (b) FDA will include the following information in the order:
    (1) The requirements of the order relating to cessation of 
distribution and notification of health professionals and device user 
facilities;
    (2) Pertinent descriptive information to enable accurate and 
immediate identification of the device subject to the order, including, 
where known:
    (i) The brand name of the device;
    (ii) The common name, classification name, or usual name of the 
device;
    (iii) The model, catalog, or product code numbers of the device; and
    (iv) The manufacturing lot numbers or serial numbers of the device 
or other identification numbers; and

[[Page 92]]

    (3) A statement of the grounds for FDA's finding that there is a 
reasonable probability that the device would cause serious, adverse 
health consequences or death.
    (c) FDA may also include in the order a model letter for notifying 
health professionals and device user facilities of the order and a 
requirement that notification of health professionals and device user 
facilities be completed within a specified timeframe. The model letter 
will include the key elements of information that the agency in its 
discretion has determined, based on the circumstances surrounding the 
issuance of each order, are necessary to inform health professionals and 
device user facilities about the order.
    (d) FDA may also require that the person named in the cease 
distribution and notification order submit any or all of the following 
information to the agency by a time specified in the order:
    (1) The total number of units of the device produced and the 
timespan of the production;
    (2) The total number of units of the device estimated to be in 
distribution channels;
    (3) The total number of units of the device estimated to be 
distributed to health professionals and device user facilities;
    (4) The total number of units of the device estimated to be in the 
hands of home users;
    (5) Distribution information, including the names and addresses of 
all consignees;
    (6) A copy of any written communication used by the person named in 
the order to notify health professionals and device user facilities;
    (7) A proposed strategy for complying with the cease distribution 
and notification order;
    (8) Progress reports to be made at specified intervals, showing the 
names and addresses of health professionals and device user facilities 
that have been notified, names of specific individuals contacted within 
device user facilities, and the dates of such contacts; and
    (9) The name, address, and telephone number of the person who should 
be contacted concerning implementation of the order.
    (e) FDA will provide the person named in a cease distribution and 
notification order with an opportunity for a regulatory hearing on the 
actions required by the cease distribution and notification order and on 
whether the order should be modified, or vacated, or amended to require 
a mandatory recall of the device.
    (f) FDA will also provide the person named in the cease distribution 
and notification order with an opportunity, in lieu of a regulatory 
hearing, to submit a written request to FDA asking that the order be 
modified, or vacated, or amended.
    (g) FDA will include in the cease distribution and notification 
order the name, address, and telephone number of an agency employee to 
whom any request for a regulatory hearing or agency review is to be 
addressed.



Sec. 810.11  Regulatory hearing.

    (a) Any request for a regulatory hearing shall be submitted in 
writing to the agency employee identified in the order within the 
timeframe specified by FDA. Under Sec. 16.22(b) of this chapter, this 
timeframe ordinarily will not be fewer than 3 working days after receipt 
of the cease distribution and notification order. However, as provided 
in Sec. 16.60(h) of this chapter, the Commissioner of Food and Drugs or 
presiding officer may waive, suspend, or modify any provision of part 16 
under Sec. 10.19 of this chapter, including those pertaining to the 
timing of the hearing. As provided in Sec. 16.26(a), the Commissioner or 
presiding officer may deny a request for a hearing, in whole or in part, 
if he or she determines that no genuine and substantial issue of fact is 
raised by the material submitted in the request.
    (b) If a request for a regulatory hearing is granted, the regulatory 
hearing shall be limited to:
    (1) Reviewing the actions required by the cease distribution and 
notification order, determining if FDA should affirm, modify, or vacate 
the order, and addressing an appropriate cease distribution and 
notification strategy; and
    (2) Determining whether FDA should amend the cease distribution and 
notification order to require a recall of the

[[Page 93]]

device that was the subject of the order. The hearing may also address 
the actions that might be required by a recall order, including an 
appropriate recall strategy, if FDA later orders a recall.
    (c) If a request by the person named in a cease distribution and 
notification order for a regulatory hearing is granted, the regulatory 
hearing will be conducted in accordance with the procedures set out in 
section 201(x) of the act (21 U.S.C. 321(x)) and part 16 of this 
chapter, except that the order issued under Sec. 810.10, rather than a 
notice under Sec. 16.22(a) of this chapter, provides the notice of 
opportunity for a hearing and is part of the administrative record of 
the regulatory hearing under Sec. 16.80(a) of this chapter. As provided 
in Sec. 16.60(h) of this chapter, the Commissioner of Food and Drugs or 
presiding officer may waive, suspend, or modify any provision of part 16 
under Sec. 10.19 of this chapter. As provided in Sec. 16.26(b), after 
the hearing commences, the presiding officer may issue a summary 
decision on any issue if the presiding officer determines that there is 
no genuine and substantial issue of fact respecting that issue.
    (d) If the person named in the cease distribution and notification 
order does not request a regulatory hearing within the timeframe 
specified by FDA in the cease distribution and notification order, that 
person will be deemed to have waived his or her right to request a 
hearing.
    (e) The presiding officer will ordinarily hold any regulatory 
hearing requested under paragraph (a) of this section no fewer than 2 
working days after receipt of the request for a hearing, under 
Sec. 16.24(e) of this chapter, and no later than 10 working days after 
the date of issuance of the cease distribution and notification order. 
However, FDA and the person named in the order may agree to a later date 
or the presiding officer may determine that the hearing should be held 
in fewer than 2 days. Moreover, as provided for in Sec. 16.60(h) of this 
chapter, the Commissioner of Food and Drugs or presiding officer may 
waive, suspend, or modify any provision of part 16 under Sec. 10.19 of 
this chapter, including those pertaining to the timing of the hearing. 
After the presiding officer prepares a written report of the hearing and 
the agency issues a final decision based on the report, the presiding 
officer shall provide the requestor written notification of the final 
decision to affirm, modify, or vacate the order or to amend the order to 
require a recall of the device within 15 working days of conducting a 
regulatory hearing.



Sec. 810.12  Written request for review of cease distribution and notification order.

    (a) In lieu of requesting a regulatory hearing under Sec. 810.11, 
the person named in a cease distribution and notification order may 
submit a written request to FDA asking that the order be modified or 
vacated. Such person shall address the written request to the agency 
employee identified in the order and shall submit the request within the 
timeframe specified in the order, unless FDA and the person named in the 
order agree to a later date.
    (b) A written request for review of a cease distribution and 
notification order shall identify each ground upon which the requestor 
relies in asking that the order be modified or vacated, as well as 
addressing an appropriate cease distribution and notification strategy, 
and shall address whether the order should be amended to require a 
recall of the device that was the subject of the order and the actions 
required by such a recall order, including an appropriate recall 
strategy.
    (c) The agency official who issued the cease distribution and 
notification order shall provide the requestor written notification of 
the agency's decision to affirm, modify, or vacate the order or amend 
the order to require a recall of the device within 15 working days of 
receipt of the written request. The agency official shall include in 
this written notification:
    (1) A statement of the grounds for the decision to affirm, modify, 
vacate, or amend the order; and
    (2) The requirements of any modified or amended order.



Sec. 810.13  Mandatory recall order.

    (a) If the person named in a cease distribution and notification 
order does

[[Page 94]]

not request a regulatory hearing or submit a request for agency review 
of the order, or, if the Commissioner of Food and Drugs or the presiding 
officer denies a request for a hearing, or, if after conducting a 
regulatory hearing under Sec. 810.11 or completing agency review of a 
cease distribution and notification order under Sec. 810.12, FDA 
determines that the order should be amended to require a recall of the 
device with respect to which the order was issued, FDA shall amend the 
order to require such a recall. FDA shall amend the order to require 
such a recall within 15 working days of issuance of a cease distribution 
and notification order if a regulatory hearing or agency review of the 
order is not requested, or within 15 working days of denying a request 
for a hearing, or within 15 working days of completing a regulatory 
hearing under Sec. 810.11, or within 15 working days of receipt of a 
written request for review of a cease distribution and notification 
order under Sec. 810.12.
    (b) In a mandatory recall order, FDA may:
    (1) Specify that the recall is to extend to the wholesale, retail, 
or user level;
    (2) Specify a timetable in accordance with which the recall is to 
begin and be completed;
    (3) Require the person named in the order to submit to the agency a 
proposed recall strategy, as described in Sec. 810.14, and periodic 
reports describing the progress of the mandatory recall, as described in 
Sec. 810.16; and
    (4) Provide the person named in the order with a model recall 
notification letter that includes the key elements of information that 
FDA has determined are necessary to inform health professionals and 
device user facilities.
    (c) FDA will not include in a mandatory recall order a requirement 
for:
    (1) Recall of a device from individuals; or
    (2) Recall of a device from device user facilities, if FDA 
determines that the risk of recalling the device from the facilities 
presents a greater health risk than the health risk of not recalling the 
device from use, unless the device can be replaced immediately with an 
equivalent device.
    (d) FDA will include in a mandatory recall order provisions for 
notification to individuals subject to the risks associated with use of 
the device. If a significant number of such individuals cannot be 
identified, FDA may notify such individuals under section 705(b) of the 
act.



Sec. 810.14  Cease distribution and notification or mandatory recall strategy.

    (a) General. The person named in a cease distribution and 
notification order issued under Sec. 810.10 shall comply with the order, 
which FDA will fashion as appropriate for the individual circumstances 
of the case. The person named in a cease distribution and notification 
order modified under Sec. 810.11(e) or Sec. 810.12(c) or a mandatory 
recall order issued under Sec. 810.13 shall develop a strategy for 
complying with the order that is appropriate for the individual 
circumstances and that takes into account the following factors:
    (1) The nature of the serious, adverse health consequences related 
to the device;
    (2) The ease of identifying the device;
    (3) The extent to which the risk presented by the device is obvious 
to a health professional or device user facility; and
    (4) The extent to which the device is used by health professionals 
and device user facilities.
    (b) Submission and review. (1) The person named in the cease 
distribution and notification order modified under Sec. 810.11(e) or 
Sec. 810.12(c) or mandatory recall order shall submit a copy of the 
proposed strategy to the agency within the timeframe specified in the 
order.
    (2) The agency will review the proposed strategy and make any 
changes to the strategy that it deems necessary within 7 working days of 
receipt of the proposed strategy. The person named in the order shall 
act in accordance with a strategy determined by FDA to be appropriate.
    (c) Elements of the strategy. A proposed strategy shall meet all of 
the following requirements:
    (1)(i) The person named in the order shall specify the level in the 
chain of distribution to which the cease distribution and notification 
order or

[[Page 95]]

mandatory recall order is to extend as follows:
    (A) Consumer or user level, e.g., health professionals, consignee, 
or device user facility level, including any intermediate wholesale or 
retail level; or
    (B) Retail level, to the level immediately preceding the consumer or 
user level, and including any intermediate level; or
    (C) Wholesale level.
    (ii) The person named in the order shall not recall a device from 
individuals; and
    (iii) The person named in the order shall not recall a device from 
device user facilities if FDA notifies the person not to do so because 
of a risk determination under Sec. 810.13(c)(2).
    (2) The person named in a recall order shall ensure that the 
strategy provides for notice to individuals subject to the risks 
associated with use of the recalled device. The notice may be provided 
through the individuals' health professionals if FDA determines that 
such consultation is appropriate and would be the most effective method 
of notifying patients.
    (3) Effectiveness checks by the person named in the order are 
required to verify that all health professionals, device user 
facilities, consignees, and individuals, as appropriate, have been 
notified of the cease distribution and notification order or mandatory 
recall order and of the need to take appropriate action. The person 
named in the cease distribution and notification order or the mandatory 
recall order shall specify in the strategy the method(s) to be used in 
addition to written communications as required by Sec. 810.15, i.e., 
personal visits, telephone calls, or a combination thereof to contact 
all health professionals, device user facilities, consignees, and 
individuals, as appropriate. The agency may conduct additional audit 
checks where appropriate.



Sec. 810.15  Communications concerning a cease distribution and notification or mandatory recall order.

    (a) General. The person named in a cease distribution and 
notification order issued under Sec. 810.10 or a mandatory recall order 
issued under Sec. 810.13 is responsible for promptly notifying each 
health professional, device user facility, consignee, or individual, as 
appropriate, of the order. In accordance with Sec. 810.10(c) or 
Sec. 810.13(b)(4), FDA may provide the person named in the cease 
distribution and notification or mandatory recall order with a model 
letter for notifying each health professional, device user facility, 
consignee, or individual, as appropriate, of the order. However, if FDA 
does not provide the person named in the cease distribution and 
notification or mandatory recall order with a model letter, the person 
named in a cease distribution and notification order issued under 
Sec. 810.10, or a mandatory recall order issued under Sec. 810.13, is 
responsible for providing such notification. The purpose of the 
communication is to convey:
    (1) That FDA has found that there is a reasonable probability that 
use of the device would cause a serious, adverse health consequence or 
death;
    (2) That the person named in the order has ceased distribution of 
the device;
    (3) That health professionals and device user facilities should 
cease use of the device immediately;
    (4) Where appropriate, that the device is subject to a mandatory 
recall order; and
    (5) Specific instructions on what should be done with the device.
    (b) Implementation. The person named in a cease distribution and 
notification order, or a mandatory recall order, shall notify the 
appropriate person(s) of the order by verified written communication, 
e.g., telegram, mailgram, or fax. The written communication and any 
envelope in which it is sent or enclosed shall be conspicuously marked, 
preferably in bold red ink: ``URGENT--[DEVICE CEASE DISTRIBUTION AND 
NOTIFICATION ORDER] or [MANDATORY DEVICE RECALL ORDER].'' Telephone 
calls or other personal contacts may be made in addition to, but not as 
a substitute for, the verified written communication, and shall be 
documented in an appropriate manner.
    (c) Contents. The person named in the order shall ensure that the 
notice of a cease distribution and notification order or mandatory 
recall order:

[[Page 96]]

    (1) Is brief and to the point;
    (2) Identifies clearly the device, size, lot number(s), code(s), or 
serial number(s), and any other pertinent descriptive information to 
facilitate accurate and immediate identification of the device;
    (3) Explains concisely the serious, adverse health consequences that 
may occur if use of the device were continued;
    (4) Provides specific instructions on what should be done with the 
device;
    (5) Provides a ready means for the recipient of the communication to 
confirm receipt of the communication and to notify the person named in 
the order of the actions taken in response to the communication. Such 
means may include, but are not limited to, the return of a postage-paid, 
self-addressed post card or a toll-free call to the person named in the 
order; and
    (6) Does not contain irrelevant qualifications, promotional 
materials, or any other statement that may detract from the message.
    (d) Followup communications. The person named in the cease 
distribution and notification order or mandatory recall order shall 
ensure that followup communications are sent to all who fail to respond 
to the initial communication.
    (e) Responsibility of the recipient. Health professionals, device 
user facilities, and consignees who receive a communication concerning a 
cease distribution and notification order or a mandatory recall order 
should immediately follow the instructions set forth in the 
communication. Where appropriate, these recipients should immediately 
notify their consignees of the order in accordance with paragraphs (b) 
and (c) of this section.



Sec. 810.16  Cease distribution and notification or mandatory recall order status reports.

    (a) The person named in a cease distribution and notification order 
issued under Sec. 810.10 or a mandatory recall order issued under 
Sec. 810.13 shall submit periodic status reports to FDA to enable the 
agency to assess the person's progress in complying with the order. The 
frequency of such reports and the agency official to whom such reports 
shall be submitted will be specified in the order.
    (b) Unless otherwise specified in the order, each status report 
shall contain the following information:
    (1) The number and type of health professionals, device user 
facilities, consignees, or individuals notified about the order and the 
date and method of notification;
    (2) The number and type of health professionals, device user 
facilities, consignees, or individuals who have responded to the 
communication and the quantity of the device on hand at these locations 
at the time they received the communication;
    (3) The number and type of health professionals, device user 
facilities, consignees, or individuals who have not responded to the 
communication;
    (4) The number of devices returned or corrected by each health 
professional, device user facility, consignee, or individual contacted, 
and the quantity of products accounted for;
    (5) The number and results of effectiveness checks that have been 
made; and
    (6) Estimated timeframes for completion of the requirements of the 
cease distribution and notification order or mandatory recall order.
    (c) The person named in the cease distribution and notification 
order or recall order may discontinue the submission of status reports 
when the agency terminates the order in accordance with Sec. 810.17.



Sec. 810.17  Termination of a cease distribution and notification or mandatory recall order.

    (a) The person named in a cease distribution and notification order 
issued under Sec. 810.10 or a mandatory recall order issued under 
Sec. 810.13 may request termination of the order by submitting a written 
request to FDA. The person submitting a request shall certify that he or 
she has complied in full with all of the requirements of the order and 
shall include a copy of the most current status report submitted to the 
agency under Sec. 810.16. A request for termination of a recall order 
shall include a description of the disposition of the recalled device.

[[Page 97]]

    (b) FDA may terminate a cease distribution and notification order 
issued under Sec. 810.10 or a mandatory recall order issued under 
Sec. 810.13 when the agency determines that the person named in the 
order:
    (1) Has taken all reasonable efforts to ensure and to verify that 
all health professionals, device user facilities, consignees, and, where 
appropriate, individuals have been notified of the cease distribution 
and notification order, and to verify that they have been instructed to 
cease use of the device and to take other appropriate action; or
    (2) Has removed the device from the market or has corrected the 
device so that use of the device would not cause serious, adverse health 
consequences or death.
    (c) FDA will provide written notification to the person named in the 
order when a request for termination of a cease distribution and 
notification order or a mandatory recall order has been granted or 
denied. FDA will respond to a written request for termination of a cease 
distribution and notification or recall order within 30 working days of 
its receipt.



Sec. 810.18  Public notice.

    The agency will make available to the public in the weekly FDA 
Enforcement Report a descriptive listing of each new mandatory recall 
issued under Sec. 810.13. The agency will delay public notification of 
orders when the agency determines that such notification may cause 
unnecessary and harmful anxiety in individuals and that initial 
consultation between individuals and their health professionals is 
essential.



PART 812--INVESTIGATIONAL DEVICE EXEMPTIONS--Table of Contents




                      Subpart A--General Provisions

Sec.
812.1  Scope.
812.2  Applicability.
812.3  Definitions.
812.5  Labeling of investigational devices.
812.7  Prohibition of promotion and other practices.
812.10  Waivers.
812.18  Import and export requirements.
812.19  Address for IDE correspondence.

            Subpart B--Application and Administrative Action

812.20  Application.
812.25  Investigational plan.
812.27  Report of prior investigations.
812.30  FDA action on applications.
812.35  Supplemental applications.
812.36  Treatment use of an investigational device.
812.38  Confidentiality of data and information.

                 Subpart C--Responsibilities of Sponsors

812.40  General responsibilities of sponsors.
812.42  FDA and IRB approval.
812.43  Selecting investigators and monitors.
812.45  Informing investigators.
812.46  Monitoring investigations.
812.47  Emergency research under Sec. 50.24 of this chapter.

                   Subpart D--IRB Review and Approval

812.60  IRB composition, duties, and functions.
812.62  IRB approval.
812.64  IRB's continuing review.
812.65  [Reserved]
812.66  Significant risk device determinations.

              Subpart E--Responsibilities of Investigators

812.100  General responsibilities of investigators.
812.110  Specific responsibilities of investigators.
812.119  Disqualification of a clinical investigator.

Subpart F  [Reserved]

                     Subpart G--Records and Reports

812.140  Records.
812.145  Inspections.
812.150  Reports.

    Authority:  21 U.S.C. 331, 351, 352, 353, 355, 360, 360c-360f, 360h-
360j, 371, 372, 374, 379e, 381, 382, 383; 42 U.S.C. 216, 241, 262, 263b-
263n.

    Source: 45 FR 3751, Jan. 18, 1980, unless otherwise noted.



                      Subpart A--General Provisions



Sec. 812.1  Scope.

    (a) The purpose of this part is to encourage, to the extent 
consistent with the protection of public health and safety and with 
ethical standards, the discovery and development of useful

[[Page 98]]

devices intended for human use, and to that end to maintain optimum 
freedom for scientific investigators in their pursuit of this purpose. 
This part provides procedures for the conduct of clinical investigations 
of devices. An approved investigational device exemption (IDE) permits a 
device that otherwise would be required to comply with a performance 
standard or to have premarket approval to be shipped lawfully for the 
purpose of conducting investigations of that device. An IDE approved 
under Sec. 812.30 or considered approved under Sec. 812.2(b) exempts a 
device from the requirements of the following sections of the Federal 
Food, Drug, and Cosmetic Act (the act) and regulations issued 
thereunder: Misbranding under section 502 of the act, registration, 
listing, and premarket notification under section 510, performance 
standards under section 514, premarket approval under section 515, a 
banned device regulation under section 516, records and reports under 
section 519, restricted device requirements under section 520(e), good 
manufacturing practice requirements under section 520(f) except for the 
requirements found in Sec. 820.30, if applicable (unless the sponsor 
states an intention to comply with these requirements under 
Sec. 812.20(b)(3) or Sec. 812.140(b)(4)(v)) and color additive 
requirements under section 721.
    (b) References in this part to regulatory sections of the Code of 
Federal Regulations are to chapter I of title 21, unless otherwise 
noted.

[45 FR 3751, Jan. 18, 1980, as amended at 59 FR 14366, Mar. 28, 1994; 61 
FR 52654, Oct. 7, 1996]



Sec. 812.2  Applicability.

    (a) General. This part applies to all clinical investigations of 
devices to determine safety and effectiveness, except as provided in 
paragraph (c) of this section.
    (b) Abbreviated requirements. The following categories of 
investigations are considered to have approved applications for IDE's, 
unless FDA has notified a sponsor under Sec. 812.20(a) that approval of 
an application is required:
    (1) An investigation of a device other than a significant risk 
device, if the device is not a banned device and the sponsor:
    (i) Labels the device in accordance with Sec. 812.5;
    (ii) Obtains IRB approval of the investigation after presenting the 
reviewing IRB with a brief explanation of why the device is not a 
significant risk device, and maintains such approval;
    (iii) Ensures that each investigator participating in an 
investigation of the device obtains from each subject under the 
investigator's care, informed consent under part 50 and documents it, 
unless documentation is waived by an IRB under Sec. 56.109(c).
    (iv) Complies with the requirements of Sec. 812.46 with respect to 
monitoring investigations;
    (v) Maintains the records required under Sec. 812.140(b) (4) and (5) 
and makes the reports required under Sec. 812.150(b) (1) through (3) and 
(5) through (10);
    (vi) Ensures that participating investigators maintain the records 
required by Sec. 812.140(a)(3)(i) and make the reports required under 
Sec. 812.150(a) (1), (2), (5), and (7); and
    (vii) Complies with the prohibitions in Sec. 812.7 against promotion 
and other practices.
    (2) An investigation of a device other than one subject to paragraph 
(e) of this section, if the investigation was begun on or before July 
16, 1980, and to be completed, and is completed, on or before January 
19, 1981.
    (c) Exempted investigations. This part, with the exception of 
Sec. 812.119, does not apply to investigations of the following 
categories of devices:
    (1) A device, other than a transitional device, in commercial 
distribution immediately before May 28, 1976, when used or investigated 
in accordance with the indications in labeling in effect at that time.
    (2) A device, other than a transitional device, introduced into 
commercial distribution on or after May 28, 1976, that FDA has 
determined to be substantially equivalent to a device in commercial 
distribution immediately before May 28, 1976, and that is used or 
investigated in accordance with the indications in the labeling FDA 
reviewed under subpart E of part 807 in determining substantial 
equivalence.
    (3) A diagnostic device, if the sponsor complies with applicable 
requirements in Sec. 809.10(c) and if the testing:

[[Page 99]]

    (i) Is noninvasive,
    (ii) Does not require an invasive sampling procedure that presents 
significant risk,
    (iii) Does not by design or intention introduce energy into a 
subject, and
    (iv) Is not used as a diagnostic procedure without confirmation of 
the diagnosis by another, medically established diagnostic product or 
procedure.
    (4) A device undergoing consumer preference testing, testing of a 
modification, or testing of a combination of two or more devices in 
commercial distribution, if the testing is not for the purpose of 
determining safety or effectiveness and does not put subjects at risk.
    (5) A device intended solely for veterinary use.
    (6) A device shipped solely for research on or with laboratory 
animals and labeled in accordance with Sec. 812.5(c).
    (7) A custom device as defined in Sec. 812.3(b), unless the device 
is being used to determine safety or effectiveness for commercial 
distribution.
    (d) Limit on certain exemptions. In the case of class II or class 
III device described in paragraph (c)(1) or (2) of this section, this 
part applies beginning on the date stipulated in an FDA regulation or 
order that calls for the submission of premarket approval applications 
for an unapproved class III device, or establishes a performance 
standard for a class II device.
    (e) Investigations subject to IND's. A sponsor that, on July 16, 
1980, has an effective investigational new drug application (IND) for an 
investigation of a device shall continue to comply with the requirements 
of part 312 until 90 days after that date. To continue the investigation 
after that date, a sponsor shall comply with paragraph (b)(1) of this 
section, if the device is not a significant risk device, or shall have 
obtained FDA approval under Sec. 812.30 of an IDE application for the 
investigation of the device.

[45 FR 3751, Jan. 18, 1980, as amended at 46 FR 8956, Jan. 27, 1981; 46 
FR 14340, Feb. 27, 1981; 53 FR 11252, Apr. 6, 1988; 62 FR 4165, Jan, 29, 
1997; 62 FR 12096, Mar. 14, 1997]



Sec. 812.3  Definitions.

    (a) Act means the Federal Food, Drug, and Cosmetic Act (sections 
201-901, 52 Stat. 1040 et seq., as amended (21 U.S.C. 301-392)).
    (b) Custom device means a device that:
    (1) Necessarily deviates from devices generally available or from an 
applicable performance standard or premarket approval requirement in 
order to comply with the order of an individual physician or dentist;
    (2) Is not generally available to, or generally used by, other 
physicians or dentists;
    (3) Is not generally available in finished form for purchase or for 
dispensing upon prescription;
    (4) Is not offered for commercial distribution through labeling or 
advertising; and
    (5) Is intended for use by an individual patient named in the order 
of a physician or dentist, and is to be made in a specific form for that 
patient, or is intended to meet the special needs of the physician or 
dentist in the course of professional practice.
    (c) FDA means the Food and Drug Administration.
    (d) Implant means a device that is placed into a surgically or 
naturally formed cavity of the human body if it is intended to remain 
there for a period of 30 days or more. FDA may, in order to protect 
public health, determine that devices placed in subjects for shorter 
periods are also ``implants'' for purposes of this part.
    (e) Institution means a person, other than an individual, who 
engages in the conduct of research on subjects or in the delivery of 
medical services to individuals as a primary activity or as an adjunct 
to providing residential or custodial care to humans. The term includes, 
for example, a hospital, retirement home, confinement facility, academic 
establishment, and device manufacturer. The term has the same meaning as 
``facility'' in section 520(g) of the act.
    (f) Institutional review board (IRB) means any board, committee, or 
other group formally designated by an institution to review biomedical 
research involving subjects and established, operated, and functioning 
in conformance with part 56. The term has the same

[[Page 100]]

meaning as ``institutional review committee'' in section 520(g) of the 
act.
    (g) Investigational device means a device, including a transitional 
device, that is the object of an investigation.
    (h) Investigation means a clinical investigation or research 
involving one or more subjects to determine the safety or effectiveness 
of a device.
    (i) Investigator means an individual who actually conducts a 
clinical investigation, i.e., under whose immediate direction the test 
article is administered or dispensed to, or used involving, a subject, 
or, in the event of an investigation conducted by a team of individuals, 
is the responsible leader of that team.
    (j) Monitor, when used as a noun, means an individual designated by 
a sponsor or contract research organization to oversee the progress of 
an investigation. The monitor may be an employee of a sponsor or a 
consultant to the sponsor, or an employee of or consultant to a contract 
research organization. Monitor, when used as a verb, means to oversee an 
investigation.
    (k) Noninvasive, when applied to a diagnostic device or procedure, 
means one that does not by design or intention: (1) Penetrate or pierce 
the skin or mucous membranes of the body, the ocular cavity, or the 
urethra, or (2) enter the ear beyond the external auditory canal, the 
nose beyond the nares, the mouth beyond the pharynx, the anal canal 
beyond the rectum, or the vagina beyond the cervical os. For purposes of 
this part, blood sampling that involves simple venipuncture is 
considered noninvasive, and the use of surplus samples of body fluids or 
tissues that are left over from samples taken for noninvestigational 
purposes is also considered noninvasive.
    (l) Person includes any individual, partnership, corporation, 
association, scientific or academic establishment, Government agency or 
organizational unit of a Government agency, and any other legal entity.
    (m) Significant risk device means an investigational device that:
    (1) Is intended as an implant and presents a potential for serious 
risk to the health, safety, or welfare of a subject;
    (2) Is purported or represented to be for a use in supporting or 
sustaining human life and presents a potential for serious risk to the 
health, safety, or welfare of a subject;
    (3) Is for a use of substantial importance in diagnosing, curing, 
mitigating, or treating disease, or otherwise preventing impairment of 
human health and presents a potential for serious risk to the health, 
safety, or welfare of a subject; or
    (4) Otherwise presents a potential for serious risk to the health, 
safety, or welfare of a subject.
    (n) Sponsor means a person who initiates, but who does not actually 
conduct, the investigation, that is, the investigational device is 
administered, dispensed, or used under the immediate direction of 
another individual. A person other than an individual that uses one or 
more of its own employees to conduct an investigation that it has 
initiated is a sponsor, not a sponsor-investigator, and the employees 
are investigators.
    (o) Sponsor-investigator means an individual who both initiates and 
actually conducts, alone or with others, an investigation, that is, 
under whose immediate direction the investigational device is 
administered, dispensed, or used. The term does not include any person 
other than an individual. The obligations of a sponsor-investigator 
under this part include those of an investigator and those of a sponsor.
    (p) Subject means a human who participates in an investigation, 
either as an individual on whom or on whose specimen an investigational 
device is used or as a control. A subject may be in normal health or may 
have a medical condition or disease.
    (q) Termination means a discontinuance, by sponsor or by withdrawal 
of IRB or FDA approval, of an investigation before completion.
    (r) Transitional device means a device subject to section 520(l) of 
the act, that is, a device that FDA considered to be a new drug or an 
antibiotic drug before May 28, 1976.
    (s) Unanticipated adverse device effect means any serious adverse 
effect on health or safety or any life-threatening problem or death 
caused by, or associated with, a device, if that effect, problem, or 
death was not previously identified in nature, severity, or degree of

[[Page 101]]

incidence in the investigational plan or application (including a 
supplementary plan or application), or any other unanticipated serious 
problem associated with a device that relates to the rights, safety, or 
welfare of subjects.

[45 FR 3751, Jan. 18, 1980, as amended at 46 FR 8956, Jan. 27, 1981; 48 
FR 15622, Apr. 12, 1983]



Sec. 812.5  Labeling of investigational devices.

    (a) Contents. An investigational device or its immediate package 
shall bear a label with the following information: the name and place of 
business of the manufacturer, packer, or distributor (in accordance with 
Sec. 801.1), the quantity of contents, if appropriate, and the following 
statement: ``CAUTION--Investigational device. Limited by Federal (or 
United States) law to investigational use.'' The label or other labeling 
shall describe all relevant contraindications, hazards, adverse effects, 
interfering substances or devices, warnings, and precautions.
    (b) Prohibitions. The labeling of an investigational device shall 
not bear any statement that is false or misleading in any particular and 
shall not represent that the device is safe or effective for the 
purposes for which it is being investigated.
    (c) Animal research. An investigational device shipped solely for 
research on or with laboratory animals shall bear on its label the 
following statement: ``CAUTION--Device for investigational use in 
laboratory animals or other tests that do not involve human subjects.''

[45 FR 3751, Jan. 18, 1980, as amended at 45 FR 58842, Sept. 5, 1980]



Sec. 812.7  Prohibition of promotion and other practices.

    A sponsor, investigator, or any person acting for or on behalf of a 
sponsor or investigator shall not:
    (a) Promote or test market an investigational device, until after 
FDA has approved the device for commercial distribution.
    (b) Commercialize an investigational device by charging the subjects 
or investigators for a device a price larger than that necessary to 
recover costs of manufacture, research, development, and handling.
    (c) Unduly prolong an investigation. If data developed by the 
investigation indicate in the case of a class III device that premarket 
approval cannot be justified or in the case of a class II device that it 
will not comply with an applicable performance standard or an amendment 
to that standard, the sponsor shall promptly terminate the 
investigation.
    (d) Represent that an investigational device is safe or effective 
for the purposes for which it is being investigated.



Sec. 812.10  Waivers.

    (a) Request. A sponsor may request FDA to waive any requirement of 
this part. A waiver request, with supporting documentation, may be 
submitted separately or as part of an application to the address in 
Sec. 812.19.
    (b) FDA action. FDA may by letter grant a waiver of any requirement 
that FDA finds is not required by the act and is unnecessary to protect 
the rights, safety, or welfare of human subjects.
    (c) Effect of request. Any requirement shall continue to apply 
unless and until FDA waives it.



Sec. 812.18  Import and export requirements.

    (a) Imports. In addition to complying with other requirements of 
this part, a person who imports or offers for importation an 
investigational device subject to this part shall be the agent of the 
foreign exporter with respect to investigations of the device and shall 
act as the sponsor of the clinical investigation, or ensure that another 
person acts as the agent of the foreign exporter and the sponsor of the 
investigation.
    (b) Exports. A person exporting an investigational device subject to 
this part shall obtain FDA's prior approval, as required by section 
801(e) of the act or comply with section 802 of the act.

[45 FR 3751, Jan. 18, 1980, as amended at 62 FR 26229, May 13, 1997]

[[Page 102]]



Sec. 812.19  Address for IDE correspondence.

    If you are sending an application, supplemental application, report, 
request for waiver, request for import or export approval, or other 
correspondence relating to matters covered by this part, you must 
address it to the Center for Devices and Radiological Health, Document 
Mail Center (HFZ-401), Food and Drug Administration, 9200 Corporate 
Blvd., Rockville, MD 20850. You must state on the outside wrapper of 
each submission what the submission is, for example, an ``IDE 
application,'' a ``supplemental IDE application,'' or a ``correspondence 
concerning an IDE (or an IDE application).''

[65 FR 17137, Mar. 31, 2000]



            Subpart B--Application and Administrative Action



Sec. 812.20  Application.

    (a) Submission. (1) A sponsor shall submit an application to FDA if 
the sponsor intends to use a significant risk device in an 
investigation, intends to conduct an investigation that involves an 
exception from informed consent under Sec. 50.24 of this chapter, or if 
FDA notifies the sponsor that an application is required for an 
investigation.
    (2) A sponsor shall not begin an investigation for which FDA's 
approval of an application is required until FDA has approved the 
application.
    (3) A sponsor shall submit three copies of a signed ``Application 
for an Investigational Device Exemption'' (IDE application), together 
with accompanying materials, by registered mail or by hand to the 
address in Sec. 812.19. Subsequent correspondence concerning an 
application or a supplemental application shall be submitted by 
registered mail or by hand.
    (4)(i) A sponsor shall submit a separate IDE for any clinical 
investigation involving an exception from informed consent under 
Sec. 50.24 of this chapter. Such a clinical investigation is not 
permitted to proceed without the prior written authorization of FDA. FDA 
shall provide a written determination 30 days after FDA receives the IDE 
or earlier.
    (ii) If the investigation involves an exception from informed 
consent under Sec. 50.24 of this chapter, the sponsor shall prominently 
identify on the cover sheet that the investigation is subject to the 
requirements in Sec. 50.24 of this chapter.
    (b) Contents. An IDE application shall include, in the following 
order:
    (1) The name and address of the sponsor.
    (2) A complete report of prior investigations of the device and an 
accurate summary of those sections of the investigational plan described 
in Sec. 812.25(a) through (e) or, in lieu of the summary, the complete 
plan. The sponsor shall submit to FDA a complete investigational plan 
and a complete report of prior investigations of the device if no IRB 
has reviewed them, if FDA has found an IRB's review inadequate, or if 
FDA requests them.
    (3) A description of the methods, facilities, and controls used for 
the manufacture, processing, packing, storage, and, where appropriate, 
installation of the device, in sufficient detail so that a person 
generally familiar with good manufacturing practices can make a 
knowledgeable judgment about the quality control used in the manufacture 
of the device.
    (4) An example of the agreements to be entered into by all 
investigators to comply with investigator obligations under this part, 
and a list of the names and addresses of all investigators who have 
signed the agreement.
    (5) A certification that all investigators who will participate in 
the investigation have signed the agreement, that the list of 
investigators includes all the investigators participating in the 
investigation, and that no investigators will be added to the 
investigation until they have signed the agreement.
    (6) A list of the name, address, and chairperson of each IRB that 
has been or will be asked to review the investigation and a 
certification of the action concerning the investigation taken by each 
such IRB.
    (7) The name and address of any institution at which a part of the 
investigation may be conducted that has not been identified in 
accordance with paragraph (b)(6) of this section.

[[Page 103]]

    (8) If the device is to be sold, the amount to be charged and an 
explanation of why sale does not constitute commercialization of the 
device.
    (9) A claim for categorical exclusion under Sec. 25.30 or 25.34 or 
an environmental assessment under Sec. 25.40.
    (10) Copies of all labeling for the device.
    (11) Copies of all forms and informational materials to be provided 
to subjects to obtain informed consent.
    (12) Any other relevant information FDA requests for review of the 
application.
    (c) Additional information. FDA may request additional information 
concerning an investigation or revision in the investigational plan. The 
sponsor may treat such a request as a disapproval of the application for 
purposes of requesting a hearing under part 16.
    (d) Information previously submitted. Information previously 
submitted to the Center for Devices and Radiological Health in 
accordance with this chapter ordinarily need not be resubmitted, but may 
be incorporated by reference.

[45 FR 3751, Jan. 18, 1980, as amended at 46 FR 8956, Jan. 27, 1981; 50 
FR 16669, Apr. 26, 1985; 53 FR 11252, Apr. 6, 1988; 61 FR 51530, Oct. 2, 
1996; 62 FR 40600, July 29, 1997; 64 FR 10942, Mar. 8, 1999]



Sec. 812.25  Investigational plan.

    The investigational plan shall include, in the following order:
    (a) Purpose. The name and intended use of the device and the 
objectives and duration of the investigation.
    (b) Protocol. A written protocol describing the methodology to be 
used and an analysis of the protocol demonstrating that the 
investigation is scientifically sound.
    (c) Risk analysis. A description and analysis of all increased risks 
to which subjects will be exposed by the investigation; the manner in 
which these risks will be minimized; a justification for the 
investigation; and a description of the patient population, including 
the number, age, sex, and condition.
    (d) Description of device. A description of each important 
component, ingredient, property, and principle of operation of the 
device and of each anticipated change in the device during the course of 
the investigation.
    (e) Monitoring procedures. The sponsor's written procedures for 
monitoring the investigation and the name and address of any monitor.
    (f) Labeling. Copies of all labeling for the device.
    (g) Consent materials. Copies of all forms and informational 
materials to be provided to subjects to obtain informed consent.
    (h) IRB information. A list of the names, locations, and 
chairpersons of all IRB's that have been or will be asked to review the 
investigation, and a certification of any action taken by any of those 
IRB's with respect to the investigation.
    (i) Other institutions. The name and address of each institution at 
which a part of the investigation may be conducted that has not been 
identified in paragraph (h) of this section.
    (j) Additional records and reports. A description of records and 
reports that will be maintained on the investigation in addition to 
those prescribed in subpart G.



Sec. 812.27  Report of prior investigations.

    (a) General. The report of prior investigations shall include 
reports of all prior clinical, animal, and laboratory testing of the 
device and shall be comprehensive and adequate to justify the proposed 
investigation.
    (b) Specific contents. The report also shall include:
    (1) A bibliography of all publications, whether adverse or 
supportive, that are relevant to an evaluation of the safety or 
effectiveness of the device, copies of all published and unpublished 
adverse information, and, if requested by an IRB or FDA, copies of other 
significant publications.
    (2) A summary of all other unpublished information (whether adverse 
or supportive) in the possession of, or reasonably obtainable by, the 
sponsor that is relevant to an evaluation of the safety or effectiveness 
of the device.
    (3) If information on nonclinical laboratory studies is provided, a 
statement that all such studies have been conducted in compliance with 
applicable requirements in the good laboratory practice regulations in 
part 58, or

[[Page 104]]

if any such study was not conducted in compliance with such regulations, 
a brief statement of the reason for the noncompliance. Failure or 
inability to comply with this requirement does not justify failure to 
provide information on a relevant nonclinical test study.

[45 FR 3751, Jan. 18, 1980, as amended at 50 FR 7518, Feb. 22, 1985]



Sec. 812.30  FDA action on applications.

    (a) Approval or disapproval. FDA will notify the sponsor in writing 
of the date it receives an application. FDA may approve an investigation 
as proposed, approve it with modifications, or disapprove it. An 
investigation may not begin until:
    (1) Thirty days after FDA receives the application at the address in 
Sec. 812.19 for the investigation of a device other than a banned 
device, unless FDA notifies the sponsor that the investigation may not 
begin; or
    (2) FDA approves, by order, an IDE for the investigation.
    (b) Grounds for disapproval or withdrawal. FDA may disapprove or 
withdraw approval of an application if FDA finds that:
    (1) There has been a failure to comply with any requirement of this 
part or the act, any other applicable regulation or statute, or any 
condition of approval imposed by an IRB or FDA.
    (2) The application or a report contains an untrue statement of a 
material fact, or omits material information required by this part.
    (3) The sponsor fails to respond to a request for additional 
information within the time prescribed by FDA.
    (4) There is reason to believe that the risks to the subjects are 
not outweighed by the anticipated benefits to the subjects and the 
importance of the knowledge to be gained, or informed consent is 
inadquate, or the investigation is scientifically unsound, or there is 
reason to believe that the device as used is ineffective.
    (5) It is otherwise unreasonable to begin or to continue the 
investigation owing to the way in which the device is used or the 
inadequacy of:
    (i) The report of prior investigations or the investigational plan;
    (ii) The methods, facilities, and controls used for the 
manufacturing, processing, packaging, storage, and, where appropriate, 
installation of the device; or
    (iii) Monitoring and review of the investigation.
    (c) Notice of disapproval or withdrawal. If FDA disapproves an 
application or proposes to withdraw approval of an application, FDA will 
notify the sponsor in writing.
    (1) A disapproval order will contain a complete statement of the 
reasons for disapproval and a statement that the sponsor has an 
opportunity to request a hearing under part 16.
    (2) A notice of a proposed withdrawal of approval will contain a 
complete statement of the reasons for withdrawal and a statement that 
the sponsor has an opportunity to request a hearing under part 16. FDA 
will provide the opportunity for hearing before withdrawal of approval, 
unless FDA determines in the notice that continuation of testing under 
the exemption will result in an unreasonble risk to the public health 
and orders withdrawal of approval before any hearing.

[45 FR 3751, Jan. 18, 1980, as amended at 45 FR 58842, Sept. 5, 1980]



Sec. 812.35  Supplemental applications.

    (a) Changes in investigational plan--(1) Changes requiring prior 
approval. Except as described in paragraphs (a)(2) through (a)(4) of 
this section, a sponsor must obtain approval of a supplemental 
application under Sec. 812.30(a), and IRB approval when appropriate (see 
Secs. 56.110 and 56.111 of this chapter), prior to implementing a change 
to an investigational plan. If a sponsor intends to conduct an 
investigation that involves an exception to informed consent under 
Sec. 50.24 of this chapter, the sponsor shall submit a separate 
investigational device exemption (IDE) application in accordance with 
Sec. 812.20(a).
    (2) Changes effected for emergency use. The requirements of 
paragraph (a)(1) of this section regarding FDA approval of a supplement 
do not apply in the case of a deviation from the investigational plan to 
protect the life or physical well-being of a subject in an emergency. 
Such deviation shall be reported to FDA within 5-working days after the 
sponsor learns of it (see Sec. 812.150(a)(4)).

[[Page 105]]

    (3) Changes effected with notice to FDA within 5 days. A sponsor may 
make certain changes without prior approval of a supplemental 
application under paragraph (a)(1) of this section if the sponsor 
determines that these changes meet the criteria described in paragraphs 
(a)(3)(i) and (a)(3)(ii) of this section, on the basis of credible 
information defined in paragraph (a)(3)(iii) of this section, and the 
sponsor provides notice to FDA within 5-working days of making these 
changes.
    (i) Developmental changes. The requirements in paragraph (a)(1) of 
this section regarding FDA approval of a supplement do not apply to 
developmental changes in the device (including manufacturing changes) 
that do not constitute a significant change in design or basic 
principles of operation and that are made in response to information 
gathered during the course of an investigation.
    (ii) Changes to clinical protocol. The requirements in paragraph 
(a)(1) of this section regarding FDA approval of a supplement do not 
apply to changes to clinical protocols that do not affect:
    (A) The validity of the data or information resulting from the 
completion of the approved protocol, or the relationship of likely 
patient risk to benefit relied upon to approve the protocol;
    (B) The scientific soundness of the investigational plan; or
    (C) The rights, safety, or welfare of the human subjects involved in 
the investigation.
    (iii) Definition of credible information. (A) Credible information 
to support developmental changes in the device (including manufacturing 
changes) includes data generated under the design control procedures of 
Sec. 820.30, preclinical/animal testing, peer reviewed published 
literature, or other reliable information such as clinical information 
gathered during a trial or marketing.
    (B) Credible information to support changes to clinical protocols is 
defined as the sponsor's documentation supporting the conclusion that a 
change does not have a significant impact on the study design or planned 
statistical analysis, and that the change does not affect the rights, 
safety, or welfare of the subjects. Documentation shall include 
information such as peer reviewed published literature, the 
recommendation of the clinical investigator(s), and/or the data gathered 
during the clinical trial or marketing.
    (iv) Notice of IDE change. Changes meeting the criteria in 
paragraphs (a)(3)(i) and (a)(3)(ii) of this section that are supported 
by credible information as defined in paragraph (a)(3)(iii) of this 
section may be made without prior FDA approval if the sponsor submits a 
notice of the change to the IDE not later than 5-working days after 
making the change. Changes to devices are deemed to occur on the date 
the device, manufactured incorporating the design or manufacturing 
change, is distributed to the investigator(s). Changes to a clinical 
protocol are deemed to occur when a clinical investigator is notified by 
the sponsor that the change should be implemented in the protocol or, 
for sponsor-investigator studies, when a sponsor-investigator 
incorporates the change in the protocol. Such notices shall be 
identified as a ``notice of IDE change.''
    (A) For a developmental or manufacturing change to the device, the 
notice shall include a summary of the relevant information gathered 
during the course of the investigation upon which the change was based; 
a description of the change to the device or manufacturing process 
(cross-referenced to the appropriate sections of the original device 
description or manufacturing process); and, if design controls were used 
to assess the change, a statement that no new risks were identified by 
appropriate risk analysis and that the verification and validation 
testing, as appropriate, demonstrated that the design outputs met the 
design input requirements. If another method of assessment was used, the 
notice shall include a summary of the information which served as the 
credible information supporting the change.
    (B) For a protocol change, the notice shall include a description of 
the change (cross-referenced to the appropriate sections of the original 
protocol); an assessment supporting the conclusion that the change does 
not have a significant impact on the study design or planned statistical 
analysis;

[[Page 106]]

and a summary of the information that served as the credible information 
supporting the sponsor's determination that the change does not affect 
the rights, safety, or welfare of the subjects.
    (4) Changes submitted in annual report. The requirements of 
paragraph (a)(1) of this section do not apply to minor changes to the 
purpose of the study, risk analysis, monitoring procedures, labeling, 
informed consent materials, and IRB information that do not affect:
    (i) The validity of the data or information resulting from the 
completion of the approved protocol, or the relationship of likely 
patient risk to benefit relied upon to approve the protocol;
    (ii) The scientific soundness of the investigational plan; or
    (iii) The rights, safety, or welfare of the human subjects involved 
in the investigation. Such changes shall be reported in the annual 
progress report for the IDE, under Sec. 812.150(b)(5).
    (b) IRB approval for new facilities. A sponsor shall submit to FDA a 
certification of any IRB approval of an investigation or a part of an 
investigation not included in the IDE application. If the investigation 
is otherwise unchanged, the supplemental application shall consist of an 
updating of the information required by Sec. 812.20(b) and (c) and a 
description of any modifications in the investigational plan required by 
the IRB as a condition of approval. A certification of IRB approval need 
not be included in the initial submission of the supplemental 
application, and such certification is not a precondition for agency 
consideration of the application. Nevertheless, a sponsor may not begin 
a part of an investigation at a facility until the IRB has approved the 
investigation, FDA has received the certification of IRB approval, and 
FDA, under Sec. 812.30(a), has approved the supplemental application 
relating to that part of the investigation (see Sec. 56.103(a)).

[50 FR 25909, June 24, 1985; 50 FR 28932, July 17, 1985, as amended at 
61 FR 51531, Oct. 2, 1996; 63 FR 64625, Nov. 23, 1998]



Sec. 812.36   Treatment use of an investigational device.

    (a) General. A device that is not approved for marketing may be 
under clinical investigation for a serious or immediately life-
threatening disease or condition in patients for whom no comparable or 
satisfactory alternative device or other therapy is available. During 
the clinical trial or prior to final action on the marketing 
application, it may be appropriate to use the device in the treatment of 
patients not in the trial under the provisions of a treatment 
investigational device exemption (IDE). The purpose of this section is 
to facilitate the availability of promising new devices to desperately 
ill patients as early in the device development process as possible, 
before general marketing begins, and to obtain additional data on the 
device's safety and effectiveness. In the case of a serious disease, a 
device ordinarily may be made available for treatment use under this 
section after all clinical trials have been completed. In the case of an 
immediately life-threatening disease, a device may be made available for 
treatment use under this section prior to the completion of all clinical 
trials. For the purpose of this section, an ``immediately life-
threatening'' disease means a stage of a disease in which there is a 
reasonable likelihood that death will occur within a matter of months or 
in which premature death is likely without early treatment. For purposes 
of this section, ``treatment use''of a device includes the use of a 
device for diagnostic purposes.
    (b) Criteria. FDA shall consider the use of an investigational 
device under a treatment IDE if:
    (1) The device is intended to treat or diagnose a serious or 
immediately life-threatening disease or condition;
    (2) There is no comparable or satisfactory alternative device or 
other therapy available to treat or diagnose that stage of the disease 
or condition in the intended patient population;
    (3) The device is under investigation in a controlled clinical trial 
for the same use under an approved IDE, or such clinical trials have 
been completed; and
    (4) The sponsor of the investigation is actively pursuing marketing 
approval/

[[Page 107]]

clearance of the investigational device with due diligence.
    (c) Applications for treatment use. (1) A treatment IDE application 
shall include, in the following order:
    (i) The name, address, and telephone number of the sponsor of the 
treatment IDE;
    (ii) The intended use of the device, the criteria for patient 
selection, and a written protocol describing the treatment use;
    (iii) An explanation of the rationale for use of the device, 
including, as appropriate, either a list of the available regimens that 
ordinarily should be tried before using the investigational device or an 
explanation of why the use of the investigational device is preferable 
to the use of available marketed treatments;
    (iv) A description of clinical procedures, laboratory tests, or 
other measures that will be used to evaluate the effects of the device 
and to minimize risk;
    (v) Written procedures for monitoring the treatment use and the name 
and address of the monitor;
    (vi) Instructions for use for the device and all other labeling as 
required under Sec. 812.5(a) and (b);
    (vii) Information that is relevant to the safety and effectiveness 
of the device for the intended treatment use. Information from other 
IDE's may be incorporated by reference to support the treatment use;
    (viii) A statement of the sponsor's commitment to meet all 
applicable responsibilities under this part and part 56 of this chapter 
and to ensure compliance of all participating investigators with the 
informed consent requirements of part 50 of this chapter;
    (ix) An example of the agreement to be signed by all investigators 
participating in the treatment IDE and certification that no 
investigator will be added to the treatment IDE before the agreement is 
signed; and
    (x) If the device is to be sold, the price to be charged and a 
statement indicating that the price is based on manufacturing and 
handling costs only.
    (2) A licensed practitioner who receives an investigational device 
for treatment use under a treatment IDE is an ``investigator'' under the 
IDE and is responsible for meeting all applicable investigator 
responsibilities under this part and parts 50 and 56 of this chapter.
    (d) FDA action on treatment IDE applications. (1) Approval of 
treatment IDE's. Treatment use may begin 30 days after FDA receives the 
treatment IDE submission at the address specified in Sec. 812.19, unless 
FDA notifies the sponsor in writing earlier than the 30 days that the 
treatment use may or may not begin. FDA may approve the treatment use as 
proposed or approve it with modifications.
    (2) Disapproval or withdrawal of approval of treatment IDE's. FDA 
may disapprove or withdraw approval of a treatment IDE if:
    (i) The criteria specified in Sec. 812.36(b) are not met or the 
treatment IDE does not contain the information required in 
Sec. 812.36(c);
    (ii) FDA determines that any of the grounds for disapproval or 
withdrawal of approval listed in Sec. 812.30(b)(1) through (b)(5) apply;
    (iii) The device is intended for a serious disease or condition and 
there is insufficient evidence of safety and effectiveness to support 
such use;
    (iv) The device is intended for an immediately life-threatening 
disease or condition and the available scientific evidence, taken as a 
whole, fails to provide a reasonable basis for concluding that the 
device:
    (A) May be effective for its intended use in its intended 
population; or
    (B) Would not expose the patients to whom the device is to be 
administered to an unreasonable and significant additional risk of 
illness or injury;
    (v) There is reasonable evidence that the treatment use is impeding 
enrollment in, or otherwise interfering with the conduct or completion 
of, a controlled investigation of the same or another investigational 
device;
    (vi) The device has received marketing approval/clearance or a 
comparable device or therapy becomes available to treat or diagnose the 
same indication in the same patient population for which the 
investigational device is being used;

[[Page 108]]

    (vii) The sponsor of the controlled clinical trial is not pursuing 
marketing approval/clearance with due diligence;
    (viii) Approval of the IDE for the controlled clinical investigation 
of the device has been withdrawn; or
    (ix) The clinical investigator(s) named in the treatment IDE are not 
qualified by reason of their scientific training and/or experience to 
use the investigational device for the intended treatment use.
    (3) Notice of disapproval or withdrawal. If FDA disapproves or 
proposes to withdraw approval of a treatment IDE, FDA will follow the 
procedures set forth in Sec. 812.30(c).
    (e) Safeguards. Treatment use of an investigational device is 
conditioned upon the sponsor and investigators complying with the 
safeguards of the IDE process and the regulations governing informed 
consent (part 50 of this chapter) and institutional review boards (part 
56 of this chapter).
    (f) Reporting requirements. The sponsor of a treatment IDE shall 
submit progress reports on a semi-annual basis to all reviewing IRB's 
and FDA until the filing of a marketing application. These reports shall 
be based on the period of time since initial approval of the treatment 
IDE and shall include the number of patients treated with the device 
under the treatment IDE, the names of the investigators participating in 
the treatment IDE, and a brief description of the sponsor's efforts to 
pursue marketing approval/clearance of the device. Upon filing of a 
marketing application, progress reports shall be submitted annually in 
accordance with Sec. 812.150(b)(5). The sponsor of a treatment IDE is 
responsible for submitting all other reports required under 
Sec. 812.150.

[62 FR 48947, Sept. 18, 1997]



Sec. 812.38  Confidentiality of data and information.

    (a) Existence of IDE. FDA will not disclose the existence of an IDE 
unless its existence has previously been publicly disclosed or 
acknowledged, until FDA approves an application for premarket approval 
of the device subject to the IDE; or a notice of completion of a product 
development protocol for the device has become effective.
    (b) Availability of summaries or data. (1) FDA will make publicly 
available, upon request, a detailed summary of information concerning 
the safety and effectiveness of the device that was the basis for an 
order approving, disapproving, or withdrawing approval of an application 
for an IDE for a banned device. The summary shall include information on 
any adverse effect on health caused by the device.
    (2) If a device is a banned device or if the existence of an IDE has 
been publicly disclosed or acknowledged, data or information contained 
in the file is not available for public disclosure before approval of an 
application for premarket approval or the effective date of a notice of 
completion of a product development protocol except as provided in this 
section. FDA may, in its discretion, disclose a summary of selected 
portions of the safety and effectiveness data, that is, clinical, 
animal, or laboratory studies and tests of the device, for public 
consideration of a specific pending issue.
    (3) If the existence of an IDE file has not been publicly disclosed 
or acknowledged, no data or information in the file are available for 
public disclosure except as provided in paragraphs (b)(1) and (c) of 
this section.
    (4) Notwithstanding paragraph (b)(2) of this section, FDA will make 
available to the public, upon request, the information in the IDE that 
was required to be filed in Docket Number 95S-0158 in the Dockets 
Management Branch (HFA-305), Food and Drug Administration, 12420 
Parklawn Dr., rm. 1-23, Rockville, MD 20857, for investigations 
involving an exception from informed consent under Sec. 50.24 of this 
chapter. Persons wishing to request this information shall submit a 
request under the Freedom of Information Act.
    (c) Reports of adverse effects. Upon request or on its own 
initiative, FDA shall disclose to an individual on whom an 
investigational device has been used a copy of a report of adverse 
device effects relating to that use.
    (d) Other rules. Except as otherwise provided in this section, the 
availability for public disclosure of data and

[[Page 109]]

information in an IDE file shall be handled in accordance with 
Sec. 814.9.

[45 FR 3751, Jan. 18, 1980, as amended at 53 FR 11253, Apr. 6, 1988; 61 
FR 51531, Oct. 2, 1996]



                 Subpart C--Responsibilities of Sponsors



Sec. 812.40  General responsibilities of sponsors.

    Sponsors are responsible for selecting qualified investigators and 
providing them with the information they need to conduct the 
investigation properly, ensuring proper monitoring of the investigation, 
ensuring that IRB review and approval are obtained, submitting an IDE 
application to FDA, and ensuring that any reviewing IRB and FDA are 
promptly informed of significant new information about an investigation. 
Additional responsibilities of sponsors are described in subparts B and 
G.



Sec. 812.42  FDA and IRB approval.

    A sponsor shall not begin an investigation or part of an 
investigation until an IRB and FDA have both approved the application or 
supplemental application relating to the investigation or part of an 
investigation.

[46 FR 8957, Jan. 27, 1981]



Sec. 812.43  Selecting investigators and monitors.

    (a) Selecting investigators. A sponsor shall select investigators 
qualified by training and experience to investigate the device.
    (b) Control of device. A sponsor shall ship investigational devices 
only to qualified investigators participating in the investigation.
    (c) Obtaining agreements. A sponsor shall obtain from each 
participating investigator a signed agreement that includes:
    (1) The investigator's curriculum vitae.
    (2) Where applicable, a statement of the investigator's relevant 
experience, including the dates, location, extent, and type of 
experience.
    (3) If the investigator was involved in an investigation or other 
research that was terminated, an explanation of the circumstances that 
led to termination.
    (4) A statement of the investigator's commitment to:
    (i) Conduct the investigation in accordance with the agreement, the 
investigational plan, this part and other applicable FDA regulations, 
and conditions of approval imposed by the reviewing IRB or FDA;
    (ii) Supervise all testing of the device involving human subjects; 
and
    (iii) Ensure that the requirements for obtaining informed consent 
are met.
    (5) Sufficient accurate financial disclosure information to allow 
the sponsor to submit a complete and accurate certification or 
disclosure statement as required under part 54 of this chapter. The 
sponsor shall obtain a commitment from the clinical investigator to 
promptly update this information if any relevant changes occur during 
the course of the investigation and for 1 year following completion of 
the study. This information shall not be submitted in an investigational 
device exemption application, but shall be submitted in any marketing 
application involving the device.
    (d) Selecting monitors. A sponsor shall select monitors qualified by 
training and experience to monitor the investigational study in 
accordance with this part and other applicable FDA regulations.

[45 FR 3751, Jan. 18, 1980, as amended at 63 FR 5253, Feb. 2, 1998]



Sec. 812.45  Informing investigators.

    A sponsor shall supply all investigators participating in the 
investigation with copies of the investigational plan and the report of 
prior investigations of the device.



Sec. 812.46  Monitoring investigations.

    (a) Securing compliance. A sponsor who discovers that an 
investigator is not complying with the signed agreement, the 
investigational plan, the requirements of this part or other applicable 
FDA regulations, or any conditions of approval imposed by the reviewing 
IRB or FDA shall promptly either secure compliance, or discontinue 
shipments of the device to the investigator and terminate the 
investigator's participation in the investigation. A

[[Page 110]]

sponsor shall also require such an investigator to dispose of or return 
the device, unless this action would jeopardize the rights, safety, or 
welfare of a subject.
    (b) Unanticipated adverse device effects. (1) A sponsor shall 
immediately conduct an evaluation of any unanticipated adverse device 
effect.
    (2) A sponsor who determines that an unanticipated adverse device 
effect presents an unreasonable risk to subjects shall terminate all 
investigations or parts of investigations presenting that risk as soon 
as possible. Termination shall occur not later than 5 working days after 
the sponsor makes this determination and not later than 15 working days 
after the sponsor first received notice of the effect.
    (c) Resumption of terminated studies. If the device is a significant 
risk device, a sponsor may not resume a terminated investigation without 
IRB and FDA approval. If the device is not a significant risk device, a 
sponsor may not resume a terminated investigation without IRB approval 
and, if the investigation was terminated under paragraph (b)(2) of this 
section, FDA approval.



Sec. 812.47  Emergency research under Sec. 50.24 of this chapter.

    (a) The sponsor shall monitor the progress of all investigations 
involving an exception from informed consent under Sec. 50.24 of this 
chapter. When the sponsor receives from the IRB information concerning 
the public disclosures under Sec. 50.24(a)(7)(ii) and (a)(7)(iii) of 
this chapter, the sponsor shall promptly submit to the IDE file and to 
Docket Number 95S-0158 in the Dockets Management Branch (HFA-305), Food 
and Drug Administration, 12420 Parklawn Dr., rm. 1-23, Rockville, MD 
20857, copies of the information that was disclosed, identified by the 
IDE number.
    (b) The sponsor also shall monitor such investigations to determine 
when an IRB determines that it cannot approve the research because it 
does not meet the criteria in the exception in Sec. 50.24(a) of this 
chapter or because of other relevant ethical concerns. The sponsor 
promptly shall provide this information in writing to FDA, investigators 
who are asked to participate in this or a substantially equivalent 
clinical investigation, and other IRB's that are asked to review this or 
a substantially equivalent investigation.

[61 FR 51531, Oct. 2, 1996, as amended at 64 FR 10943, Mar. 8, 1999]



                   Subpart D--IRB Review and Approval



Sec. 812.60  IRB composition, duties, and functions.

    An IRB reviewing and approving investigations under this part shall 
comply with the requirements of part 56 in all respects, including its 
composition, duties, and functions.

[46 FR 8957, Jan. 27, 1981]



Sec. 812.62  IRB approval.

    (a) An IRB shall review and have authority to approve, require 
modifications in (to secure approval), or disapprove all investigations 
covered by this part.
    (b) If no IRB exists or if FDA finds that an IRB's review is 
inadequate, a sponsor may submit an application to FDA.

[46 FR 8957, Jan. 27, 1981]



Sec. 812.64  IRB's continuing review.

    The IRB shall conduct its continuing review of an investigation in 
accordance with part 56.

[46 FR 8957, Jan. 27, 1981]



Sec. 812.65  [Reserved]



Sec. 812.66  Significant risk device determinations.

    If an IRB determines that an investigation, presented for approval 
under Sec. 812.2(b)(1)(ii), involves a significant risk device, it shall 
so notify the investigator and, where appropriate, the sponsor. A 
sponsor may not begin the investigation except as provided in 
Sec. 812.30(a).

[46 FR 8957, Jan. 27, 1981]

[[Page 111]]



              Subpart E--Responsibilities of Investigators



Sec. 812.100  General responsibilities of investigators.

    An investigator is responsible for ensuring that an investigation is 
conducted according to the signed agreement, the investigational plan 
and applicable FDA regulations, for protecting the rights, safety, and 
welfare of subjects under the investigator's care, and for the control 
of devices under investigation. An investigator also is responsible for 
ensuring that informed consent is obtained in accordance with part 50 of 
this chapter. Additional responsibilities of investigators are described 
in subpart G.

[45 FR 3751, Jan. 18, 1980, as amended at 46 FR 8957, Jan. 27, 1981]



Sec. 812.110  Specific responsibilities of investigators.

    (a) Awaiting approval. An investigator may determine whether 
potential subjects would be interested in participating in an 
investigation, but shall not request the written informed consent of any 
subject to participate, and shall not allow any subject to participate 
before obtaining IRB and FDA approval.
    (b) Compliance. An investigator shall conduct an investigation in 
accordance with the signed agreement with the sponsor, the 
investigational plan, this part and other applicable FDA regulations, 
and any conditions of approval imposed by an IRB or FDA.
    (c) Supervising device use. An investigator shall permit an 
investigational device to be used only with subjects under the 
investigator's supervision. An investigator shall not supply an 
investigational device to any person not authorized under this part to 
receive it.
    (d) Financial disclosure. A clinical investigator shall disclose to 
the sponsor sufficient accurate financial information to allow the 
applicant to submit complete and accurate certification or disclosure 
statements required under part 54 of this chapter. The investigator 
shall promptly update this information if any relevant changes occur 
during the course of the investigation and for 1 year following 
completion of the study.
    (e) Disposing of device. Upon completion or termination of a 
clinical investigation or the investigator's part of an investigation, 
or at the sponsor's request, an investigator shall return to the sponsor 
any remaining supply of the device or otherwise dispose of the device as 
the sponsor directs.

[45 FR 3751, Jan. 18, 1980, as amended at 63 FR 5253, Feb. 2, 1998]



Sec. 812.119  Disqualification of a clinical investigator.

    (a) If FDA has information indicating that an investigator has 
repeatedly or deliberately failed to comply with the requirements of 
this part, part 50, or part 56 of this chapter, or has repeatedly or 
deliberately submitted false information either to the sponsor of the 
investigation or in any required report, the Center for Devices and 
Radiological Health will furnish the investigator written notice of the 
matter under complaint and offer the investigator an opportunity to 
explain the matter in writing, or, at the option of the investigator, in 
an informal conference. If an explanation is offered and accepted by the 
Center for Devices and Radiological Health, the disqualification process 
will be terminated. If an explanation is offered but not accepted by the 
Center for Devices and Radiological Health, the investigator will be 
given an opportunity for a regulatory hearing under part 16 of this 
chapter on the question of whether the investigator is entitled to 
receive investigational devices.
    (b) After evaluating all available information, including any 
explanation presented by the investigator, if the Commissioner 
determines that the investigator has repeatedly or deliberately failed 
to comply with the requirements of this part, part 50, or part 56 of 
this chapter, or has deliberately or repeatedly submitted false 
information either to the sponsor of the investigation or in any 
required report, the Commissioner will notify the investigator, the 
sponsor of any investigation in which the investigator has been

[[Page 112]]

named as a participant, and the reviewing IRB that the investigator is 
not entitled to receive investigational devices. The notification will 
provide a statement of basis for such determination.
    (c) Each investigational device exemption (IDE) and each cleared or 
approved application submitted under this part, subpart E of part 807 of 
this chapter, or part 814 of this chapter containing data reported by an 
investigator who has been determined to be ineligible to receive 
investigational devices will be examined to determine whether the 
investigator has submitted unreliable data that are essential to the 
continuation of the investigation or essential to the approval or 
clearance of any marketing application.
    (d) If the Commissioner determines, after the unreliable data 
submitted by the investigator are eliminated from consideration, that 
the data remaining are inadequate to support a conclusion that it is 
reasonably safe to continue the investigation, the Commissioner will 
notify the sponsor who shall have an opportunity for a regulatory 
hearing under part 16 of this chapter. If a danger to the public health 
exists, however, the Commissioner shall terminate the IDE immediately 
and notify the sponsor and the reviewing IRB of the determination. In 
such case, the sponsor shall have an opportunity for a regulatory 
hearing before FDA under part 16 of this chapter on the question of 
whether the IDE should be reinstated.
    (e) If the Commissioner determines, after the unreliable data 
submitted by the investigator are eliminated from consideration, that 
the continued clearance or approval of the marketing application for 
which the data were submitted cannot be justified, the Commissioner will 
proceed to withdraw approval or rescind clearance of the medical device 
in accordance with the applicable provisions of the act.
    (f) An investigator who has been determined to be ineligible to 
receive investigational devices may be reinstated as eligible when the 
Commissioner determines that the investigator has presented adequate 
assurances that the investigator will employ investigational devices 
solely in compliance with the provisions of this part and of parts 50 
and 56 of this chapter.

[62 FR 12096, Mar. 14, 1997]

Subpart F  [Reserved]



                     Subpart G--Records and Reports



Sec. 812.140  Records.

    (a) Investigator records. A participating investigator shall 
maintain the following accurate, complete, and current records relating 
to the investigator's participation in an investigation:
    (1) All correspondence with another investigator, an IRB, the 
sponsor, a monitor, or FDA, including required reports.
    (2) Records of receipt, use or disposition of a device that relate 
to:
    (i) The type and quantity of the device, the dates of its receipt, 
and the batch number or code mark.
    (ii) The names of all persons who received, used, or disposed of 
each device.
    (iii) Why and how many units of the device have been returned to the 
sponsor, repaired, or otherwise disposed of.
    (3) Records of each subject's case history and exposure to the 
device. Case histories include the case report forms and supporting data 
including, for example, signed and dated consent forms and medical 
records including, for example, progress notes of the physician, the 
individual's hospital chart(s), and the nurses' notes. Such records 
shall include:
    (i) Documents evidencing informed consent and, for any use of a 
device by the investigator without informed consent, any written 
concurrence of a licensed physician and a brief description of the 
circumstances justifying the failure to obtain informed consent. The 
case history for each individual shall document that informed consent 
was obtained prior to participation in the study.
    (ii) All relevant observations, including records concerning adverse 
device effects (whether anticipated or unanticipated), information and 
data on the condition of each subject upon entering, and during the 
course of, the investigation, including information

[[Page 113]]

about relevant previous medical history and the results of all 
diagnostic tests.
    (iii) A record of the exposure of each subject to the 
investigational device, including the date and time of each use, and any 
other therapy.
    (4) The protocol, with documents showing the dates of and reasons 
for each deviation from the protocol.
    (5) Any other records that FDA requires to be maintained by 
regulation or by specific requirement for a category of investigations 
or a particular investigation.
    (b) Sponsor records. A sponsor shall maintain the following 
accurate, complete, and current records relating to an investigation:
    (1) All correspondence with another sponsor, a monitor, an 
investigator, an IRB, or FDA, including required reports.
    (2) Records of shipment and disposition. Records of shipment shall 
include the name and address of the consignee, type and quantity of 
device, date of shipment, and batch number or code mark. Records of 
disposition shall describe the batch number or code marks of any devices 
returned to the sponsor, repaired, or disposed of in other ways by the 
investigator or another person, and the reasons for and method of 
disposal.
    (3) Signed investigator agreements including the financial 
disclosure information required to be collected under Sec. 812.43(c)(5) 
in accordance with part 54 of this chapter.
    (4) For each investigation subject to Sec. 812.2(b)(1) of a device 
other than a significant risk device, the records described in paragraph 
(b)(5) of this section and the following records, consolidated in one 
location and available for FDA inspection and copying:
    (i) The name and intended use of the device and the objectives of 
the investigation;
    (ii) A brief explanation of why the device is not a significant risk 
device:
    (iii) The name and address of each investigator:
    (iv) The name and address of each IRB that has reviewed the 
investigation:
    (v) A statement of the extent to which the good manufacturing 
practice regulation in part 820 will be followed in manufacturing the 
device; and
    (vi) Any other information required by FDA.
    (5) Records concerning adverse device effects (whether anticipated 
or unanticipated) and complaints and
    (6) Any other records that FDA requires to be maintained by 
regulation or by specific requirement for a category of investigation or 
a particular investigation.
    (c) IRB records. An IRB shall maintain records in accordance with 
part 56 of this chapter.
    (d) Retention period. An investigator or sponsor shall maintain the 
records required by this subpart during the investigation and for a 
period of 2 years after the latter of the following two dates: The date 
on which the investigation is terminated or completed, or the date that 
the records are no longer required for purposes of supporting a 
premarket approval application or a notice of completion of a product 
development protocol.
    (e) Records custody. An investigator or sponsor may withdraw from 
the responsibility to maintain records for the period required in 
paragraph (d) of this section and transfer custody of the records to any 
other person who will accept responsibility for them under this part, 
including the requirements of Sec. 812.145. Notice of a transfer shall 
be given to FDA not later than 10 working days after transfer occurs.

[45 FR 3751, Jan. 18, 1980, as amended at 45 FR 58843, Sept. 5, 1980; 46 
FR 8957, Jan. 27, 1981; 61 FR 57280, Nov. 5, 1996; 63 FR 5253, Feb. 2, 
1998]



Sec. 812.145  Inspections.

    (a) Entry and inspection. A sponsor or an investigator who has 
authority to grant access shall permit authorized FDA employees, at 
reasonable times and in a reasonable manner, to enter and inspect any 
establishment where devices are held (including any establishment where 
devices are manufactured, processed, packed, installed, used, or 
implanted or where records of results from use of devices are kept).
    (b) Records inspection. A sponsor, IRB, or investigator, or any 
other person acting on behalf of such a person with

[[Page 114]]

respect to an investigation, shall permit authorized FDA employees, at 
reasonable times and in a reasonable manner, to inspect and copy all 
records relating to an investigation.
    (c) Records identifying subjects. An investigator shall permit 
authorized FDA employees to inspect and copy records that identify 
subjects, upon notice that FDA has reason to suspect that adequate 
informed consent was not obtained, or that reports required to be 
submitted by the investigator to the sponsor or IRB have not been 
submitted or are incomplete, inaccurate, false, or misleading.



Sec. 812.150  Reports.

    (a) Investigator reports. An investigator shall prepare and submit 
the following complete, accurate, and timely reports:
    (1) Unanticipated adverse device effects. An investigator shall 
submit to the sponsor and to the reviewing IRB a report of any 
unanticipated adverse device effect occurring during an investigation as 
soon as possible, but in no event later than 10 working days after the 
investigator first learns of the effect.
    (2) Withdrawal of IRB approval. An investigator shall report to the 
sponsor, within 5 working days, a withdrawal of approval by the 
reviewing IRB of the investigator's part of an investigation.
    (3) Progress. An investigator shall submit progress reports on the 
investigation to the sponsor, the monitor, and the reviewing IRB at 
regular intervals, but in no event less often than yearly.
    (4) Deviations from the investigational plan. An investigator shall 
notify the sponsor and the reviewing IRB (see Sec. 56.108(a) (3) and 
(4)) of any deviation from the investigational plan to protect the life 
or physical well-being of a subject in an emergency. Such notice shall 
be given as soon as possible, but in no event later than 5 working days 
after the emergency occurred. Except in such an emergency, prior 
approval by the sponsor is required for changes in or deviations from a 
plan, and if these changes or deviations may affect the scientific 
soundness of the plan or the rights, safety, or welfare of human 
subjects, FDA and IRB in accordance with Sec. 812.35(a) also is 
required.
    (5) Informed consent. If an investigator uses a device without 
obtaining informed consent, the investigator shall report such use to 
the sponsor and the reviewing IRB within 5 working days after the use 
occurs.
    (6) Final report. An investigator shall, within 3 months after 
termination or completion of the investigation or the investigator's 
part of the investigation, submit a final report to the sponsor and the 
reviewing IRB.
    (7) Other. An investigator shall, upon request by a reviewing IRB or 
FDA, provide accurate, complete, and current information about any 
aspect of the investigation.
    (b) Sponsor reports. A sponsor shall prepare and submit the 
following complete, accurate, and timely reports:
    (1) Unanticipated adverse device effects. A sponsor who conducts an 
evaluation of an unanticipated adverse device effect under 
Sec. 812.46(b) shall report the results of such evaluation to FDA and to 
all reviewing IRB's and participating investigators within 10 working 
days after the sponsor first receives notice of the effect. Thereafter 
the sponsor shall submit such additional reports concerning the effect 
as FDA requests.
    (2) Withdrawal of IRB approval. A sponsor shall notify FDA and all 
reviewing IRB's and participating investigators of any withdrawal of 
approval of an investigation or a part of an investigation by a 
reviewing IRB within 5 working days after receipt of the withdrawal of 
approval.
    (3) Withdrawal of FDA approval. A sponsor shall notify all reviewing 
IRB's and participating investigators of any withdrawal of FDA approval 
of the investigation, and shall do so within 5 working days after 
receipt of notice of the withdrawal of approval.
    (4) Current investigator list. A sponsor shall submit to FDA, at 6-
month intervals, a current list of the names and addresses of all 
investigators participating in the investigation. The sponsor shall 
submit the first such list 6 months after FDA approval.
    (5) Progress reports. At regular intervals, and at least yearly, a 
sponsor

[[Page 115]]

shall submit progress reports to all reviewing IRB's. In the case of a 
significant risk device, a sponsor shall also submit progress reports to 
FDA. A sponsor of a treatment IDE shall submit semi-annual progress 
reports to all reviewing IRB's and FDA in accordance with Sec. 812.36(f) 
and annual reports in accordance with this section.
    (6) Recall and device disposition. A sponsor shall notify FDA and 
all reviewing IRB's of any request that an investigator return, repair, 
or otherwise dispose of any units of a device. Such notice shall occur 
within 30 working days after the request is made and shall state why the 
request was made.
    (7) Final report. In the case of a significant risk device, the 
sponsor shall notify FDA within 30 working days of the completion or 
termination of the investigation and shall submit a final report to FDA 
and all reviewing the IRB's and participating investigators within 6 
months after completion or termination. In the case of a device that is 
not a significant risk device, the sponsor shall submit a final report 
to all reviewing IRB's within 6 months after termination or completion.
    (8) Informed consent. A sponsor shall submit to FDA a copy of any 
report by an investigator under paragraph (a)(5) of this section of use 
of a device without obtaining informed consent, within 5 working days of 
receipt of notice of such use.
    (9) Significant risk device determinations. If an IRB determines 
that a device is a significant risk device, and the sponsor had proposed 
that the IRB consider the device not to be a significant risk device, 
the sponsor shall submit to FDA a report of the IRB's determination 
within 5 working days after the sponsor first learns of the IRB's 
determination.
    (10) Other. A sponsor shall, upon request by a reviewing IRB or FDA, 
provide accurate, complete, and current information about any aspect of 
the investigation.

[45 FR 3751, Jan. 18, 1980, as amended at 45 FR 58843, Sept. 5, 1980; 48 
FR 15622, Apr. 12, 1983; 62 FR 48948, Sept. 18, 1997]



PART 813  [RESERVED]






PART 814--PREMARKET APPROVAL OF MEDICAL DEVICES--Table of Contents




                           Subpart A--General

Sec.
814.1  Scope.
814.2  Purpose.
814.3  Definitions.
814.9  Confidentiality of data and information in a premarket approval 
          application (PMA) file.
814.15  Research conducted outside the United States.
814.17  Service of orders.
814.19  Product development protocol (PDP).

             Subpart B--Premarket Approval Application (PMA)

814.20  Application.
814.37  PMA amendments and resubmitted PMA's.
814.39  PMA supplements.

                     Subpart C--FDA Action on a PMA

814.40  Time frames for reviewing a PMA.
814.42  Filing a PMA.
814.44  Procedures for review of a PMA.
814.45  Denial of approval of a PMA.
814.46  Withdrawal of approval of a PMA.
814.47  Temporary suspension of approval of a PMA.

Subpart D--Administrative Review  [Reserved]

                  Subpart E--Postapproval Requirements

814.80  General.
814.82  Postapproval requirements.
814.84  Reports.

Subparts F-G  [Reserved]

                   Subpart H--Humanitarian Use Devices

814.100  Purpose and scope.
814.102  Designation of HUD status.
814.104  Original applications.
814.106  HDE amendments and resubmitted HDE's.
814.108  Supplemental applications.
814.110  New indications for use.
814.112  Filing an HDE.
814.114  Timeframes for reviewing an HDE.
814.116  Procedures for review of an HDE.
814.118  Denial of approval or withdrawal of approval of an HDE.
814.120  Temporary suspension of approval of an HDE.
814.122  Confidentiality of data and information.

[[Page 116]]

814.124  Institutional Review Board requirements.
814.126  Postapproval requirements and reports.

    Authority: 21 U.S.C. 351, 352, 353, 360, 360c-360j, 371, 372, 373, 
374, 375, 379, 379e, 381.

    Source: 51 FR 26364, July 22, 1986, unless otherwise noted.



                           Subpart A--General



Sec. 814.1  Scope.

    (a) This part implements section 515 of the act by providing 
procedures for the premarket approval of medical devices intended for 
human use.
    (b) References in this part to regulatory sections of the Code of 
Federal Regulations are to chapter I of title 21, unless otherwise 
noted.
    (c) This part applies to any class III medical device, unless exempt 
under section 520(g) of the act, that:
    (1) Was not on the market (introduced or delivered for introduction 
into commerce for commercial distribution) before May 28, 1976, and is 
not substantially equivalent to a device on the market before May 28, 
1976, or to a device first marketed on, or after that date, which has 
been classified into class I or class II; or
    (2) Is required to have an approved premarket approval application 
(PMA) or a declared completed product development protocol under a 
regulation issued under section 515(b) of the act; or
    (3) Was regulated by FDA as a new drug or antibiotic drug before May 
28, 1976, and therefore is governed by section 520(1) of the act.
    (d) This part amends the conditions to approval for any PMA approved 
before the effective date of this part. Any condition to approval for an 
approved PMA that is inconsistent with this part is revoked. Any 
condition to approval for an approved PMA that is consistent with this 
part remains in effect.



Sec. 814.2  Purpose.

    The purpose of this part is to establish an efficient and thorough 
device review process--
    (a) To facilitate the approval of PMA's for devices that have been 
shown to be safe and effective and that otherwise meet the statutory 
criteria for approval; and
    (b) To ensure the disapproval of PMA's for devices that have not 
been shown to be safe and effective or that do not otherwise meet the 
statutory criteria for approval. This part shall be construed in light 
of these objectives.



Sec. 814.3  Definitions.

    For the purposes of this part:
    (a) Act means the Federal Food, Drug, and Cosmetic Act (sections 
201-902, 52 Stat. 1040 et seq., as amended (21 U.S.C. 321-392)).
    (b) FDA means the Food and Drug Administration.
    (c) IDE means an approved or considered approved investigational 
device exemption under section 520(g) of the act and parts 812 and 813.
    (d) Master file means a reference source that a person submits to 
FDA. A master file may contain detailed information on a specific 
manufacturing facility, process, methodology, or component used in the 
manufacture, processing, or packaging of a medical device.
    (e) PMA means any premarket approval application for a class III 
medical device, including all information submitted with or incorporated 
by reference therein. ``PMA'' includes a new drug application for a 
device under section 520(1) of the act.
    (f) PMA amendment means information an applicant submits to FDA to 
modify a pending PMA or a pending PMA supplement.
    (g) PMA supplement means a supplemental application to an approved 
PMA for approval of a change or modification in a class III medical 
device, including all information submitted with or incorporated by 
reference therein.
    (h) Person includes any individual, partnership, corporation, 
association, scientific or academic establishment, Government agency, or 
organizational unit thereof, or any other legal entity.
    (i) Statement of material fact means a representation that tends to 
show that the safety or effectiveness of a device is more probable than 
it would be in the absence of such a representation. A

[[Page 117]]

false affirmation or silence or an omission that would lead a reasonable 
person to draw a particular conclusion as to the safety or effectiveness 
of a device also may be a false statement of material fact, even if the 
statement was not intended by the person making it to be misleading or 
to have any probative effect.
    (j) 30-day PMA supplement means a supplemental application to an 
approved PMA in accordance with Sec. 814.39(e).
    (k) Reasonable probability means that it is more likely than not 
that an event will occur.
    (l) Serious, adverse health consequences means any significant 
adverse experience, including those which may be either life-threatening 
or involve permanent or long term injuries, but excluding injuries that 
are nonlife-threatening and that are temporary and reasonably 
reversible.
    (m) HDE means a premarket approval application submitted pursuant to 
this subpart seeking a humanitarian device exemption from the 
effectiveness requirements of sections 514 and 515 of the act as 
authorized by section 520(m)(2) of the act.
    (n) HUD (humanitarian use device) means a medical device intended to 
benefit patients in the treatment or diagnosis of a disease or condition 
that affects or is manifested in fewer than 4,000 individuals in the 
United States per year.

[51 FR 26364, July 22, 1986, as amended at 61 FR 15190, Apr. 5, 1996; 61 
FR 33244, June 26, 1996]



Sec. 814.9  Confidentiality of data and information in a premarket approval application (PMA) file.

    (a) A ``PMA file'' includes all data and information submitted with 
or incorporated by reference in the PMA, any IDE incorporated into the 
PMA, any PMA supplement, any report under Sec. 814.82, any master file, 
or any other related submission. Any record in the PMA file will be 
available for public disclosure in accordance with the provisions of 
this section and part 20. The confidentiality of information in a color 
additive petition submitted as part of a PMA is governed by Sec. 71.15.
    (b) The existence of a PMA file may not be disclosed by FDA before 
an approval order is issued to the applicant unless it previously has 
been publicly disclosed or acknowledged.
    (c) If the existence of a PMA file has not been publicly disclosed 
or acknowledged, data or information in the PMA file are not available 
for public disclosure.
    (d)(1) If the existence of a PMA file has been publicly disclosed or 
acknowledged before an order approving, or an order denying approval of 
the PMA is issued, data or information contained in the file are not 
available for public disclosure before such order issues. FDA may, 
however, disclose a summary of portions of the safety and effectiveness 
data before an approval order or an order denying approval of the PMA 
issues if disclosure is relevant to public consideration of a specific 
pending issue.
    (2) Notwithstanding paragraph (d)(1) of this section, FDA will make 
available to the public upon request the information in the IDE that was 
required to be filed in Docket Number 95S-0158 in the Dockets Management 
Branch (HFA-305), Food and Drug Administration, 12420 Parklawn Dr., rm. 
1-23, Rockville, MD 20857, for investigations involving an exception 
from informed consent under Sec. 50.24 of this chapter. Persons wishing 
to request this information shall submit a request under the Freedom of 
Information Act.
    (e) Upon issuance of an order approving, or an order denying 
approval of any PMA, FDA will make available to the public the fact of 
the existence of the PMA and a detailed summary of information submitted 
to FDA respecting the safety and effectiveness of the device that is the 
subject of the PMA and that is the basis for the order.
    (f) After FDA issues an order approving, or an order denying 
approval of any PMA, the following data and information in the PMA file 
are immediately available for public disclosure:
    (1) All safety and effectiveness data and information previously 
disclosed to the public, as such disclosure is defined in Sec. 20.81.
    (2) Any protocol for a test or study unless the protocol is shown to 
constitute trade secret or confidential

[[Page 118]]

commercial or financial information under Sec. 20.61.
    (3) Any adverse reaction report, product experience report, consumer 
complaint, and other similar data and information, after deletion of:
    (i) Any information that constitutes trade secret or confidential 
commercial or financial information under Sec. 20.61; and
    (ii) Any personnel, medical, and similar information disclosure of 
which would constitute a clearly unwarranted invasion of personal 
privacy under Sec. 20.63; provided, however, that except for the 
information that constitutes trade secret or confidential commercial or 
financial information under Sec. 20.61, FDA will disclose to a patient 
who requests a report all the information in the report concerning that 
patient.
    (4) A list of components previously disclosed to the public, as such 
disclosure is defined in Sec. 20.81.
    (5) An assay method or other analytical method, unless it does not 
serve any regulatory purpose and is shown to fall within the exemption 
in Sec. 20.61 for trade secret or confidential commercial or financial 
information.
    (6) All correspondence and written summaries of oral discussions 
relating to the PMA file, in accordance with the provisions of 
Secs. 20.103 and 20.104.
    (g) All safety and effectiveness data and other information not 
previously disclosed to the public are available for public disclosure 
if any one of the following events occurs and the data and information 
do not constitute trade secret or confidential commercial or financial 
information under Sec. 20.61:
    (1) The PMA has been abandoned. FDA will consider a PMA abandoned 
if:
    (i)(A) The applicant fails to respond to a request for additional 
information within 180 days after the date FDA issues the request or
    (B) Other circumstances indicate that further work is not being 
undertaken with respect to it, and
    (ii) The applicant fails to communicate with FDA within 7 days after 
the date on which FDA notifies the applicant that the PMA appears to 
have been abandoned.
    (2) An order denying approval of the PMA has issued, and all legal 
appeals have been exhausted.
    (3) An order withdrawing approval of the PMA has issued, and all 
legal appeals have been exhausted.
    (4) The device has been reclassified.
    (5) The device has been found to be substantially equivalent to a 
class I or class II device.
    (6) The PMA is considered voluntarily withdrawn under 
Sec. 814.44(g).
    (h) The following data and information in a PMA file are not 
available for public disclosure unless they have been previously 
disclosed to the public, as such disclosure is defined in Sec. 20.81, or 
they relate to a device for which a PMA has been abandoned and they no 
longer represent a trade secret or confidential commercial or financial 
information as defined in Sec. 20.61:
    (1) Manufacturing methods or processes, including quality control 
procedures.
    (2) Production, sales, distribution, and similar data and 
information, except that any compilation of such data and information 
aggregated and prepared in a way that does not reveal data or 
information which are not available for public disclosure under this 
provision is available for public disclosure.
    (3) Quantitative or semiquantitative formulas.

[51 FR 26364, July 22, 1986, as amended at 61 FR 51531, Oct. 2, 1996]



Sec. 814.15  Research conducted outside the United States.

    (a) A study conducted outside the United States submitted in support 
of a PMA and conducted under an IDE shall comply with part 812. A study 
conducted outside the United States submitted in support of a PMA and 
not conducted under an IDE shall comply with the provisions in paragraph 
(b) or (c) of this section, as applicable.
    (b) Research begun on or after effective date. FDA will accept 
studies submitted in support of a PMA which have been conducted outside 
the United States and begun on or after November 19, 1986, if the data 
are valid and the investigator has conducted the studies in conformance 
with the ``Declaration of Helsinki'' or the laws and regulations

[[Page 119]]

of the country in which the research is conducted, whichever accords 
greater protection to the human subjects. If the standards of the 
country are used, the applicant shall state in detail any differences 
between those standards and the ``Declaration of Helsinki'' and explain 
why they offer greater protection to the human subjects.
    (c) Research begun before effective date. FDA will accept studies 
submitted in support of a PMA which have been conducted outside the 
United States and begun before November 19, 1986, if FDA is satisfied 
that the data are scientifically valid and that the rights, safety, and 
welfare of human subjects have not been violated.
    (d) As sole basis for marketing approval. A PMA based solely on 
foreign clinical data and otherwise meeting the criteria for approval 
under this part may be approved if:
    (1) The foreign data are applicable to the U.S. population and U.S. 
medical practice;
    (2) The studies have been performed by clinical investigators of 
recognized competence; and
    (3) The data may be considered valid without the need for an on-site 
inspection by FDA or, if FDA considers such an inspection to be 
necessary, FDA can validate the data through an on-site inspection or 
other appropriate means.
    (e) Consultation between FDA and applicants. Applicants are 
encouraged to meet with FDA officials in a ``presubmission'' meeting 
when approval based solely on foreign data will be sought.

(Approved by the Office of Management and Budget under control number 
0910-0231)

[51 FR 26364, July 22, 1986; 51 FR 40415, Nov. 7, 1986, as amended at 51 
FR 43344, Dec. 2, 1986]



Sec. 814.17  Service of orders.

    Orders issued under this part will be served in person by a 
designated officer or employee of FDA on, or by registered mail to, the 
applicant or the designated agent at the applicant's or designated 
agent's last known address in FDA's records.



Sec. 814.19  Product development protocol (PDP).

    A class III device for which a product development protocol has been 
declared completed by FDA under this chapter will be considered to have 
an approved PMA.



             Subpart B--Premarket Approval Application (PMA)



Sec. 814.20  Application.

    (a) The applicant or an authorized representative shall sign the 
PMA. If the applicant does not reside or have a place of business within 
the United States, the PMA shall be countersigned by an authorized 
representative residing or maintaining a place of business in the United 
States and shall identify the representative's name and address.
    (b) Unless the applicant justifies an omission in accordance with 
paragraph (d) of this section, a PMA shall include:
    (1) The name and address of the applicant.
    (2) A table of contents that specifies the volume and page number 
for each item referred to in the table. A PMA shall include separate 
sections on nonclinical laboratory studies and on clinical 
investigations involving human subjects. A PMA shall be submitted in six 
copies each bound in one or more numbered volumes of reasonable size. 
The applicant shall include information that it believes to be trade 
secret or confidential commercial or financial information in all copies 
of the PMA and identify in at least one copy the information that it 
believes to be trade secret or confidential commercial or financial 
information.
    (3) A summary in sufficient detail that the reader may gain a 
general understanding of the data and information in the application. 
The summary shall contain the following information:
    (i) Indications for use. A general description of the disease or 
condition the device will diagnose, treat, prevent, cure, or mitigate, 
including a description of the patient population for which the device 
is intended.
    (ii) Device description. An explanation of how the device functions, 
the basic scientific concepts that form the basis

[[Page 120]]

for the device, and the significant physical and performance 
characteristics of the device. A brief description of the manufacturing 
process should be included if it will significantly enhance the reader's 
understanding of the device. The generic name of the device as well as 
any proprietary name or trade name should be included.
    (iii) Alternative practices and procedures. A description of 
existing alternative practices or procedures for diagnosing, treating, 
preventing, curing, or mitigating the disease or condition for which the 
device is intended.
    (iv) Marketing history. A brief description of the foreign and U.S. 
marketing history, if any, of the device, including a list of all 
countries in which the device has been marketed and a list of all 
countries in which the device has been withdrawn from marketing for any 
reason related to the safety or effectiveness of the device. The 
description shall include the history of the marketing of the device by 
the applicant and, if known, the history of the marketing of the device 
by any other person.
    (v) Summary of studies. An abstract of any information or report 
described in the PMA under paragraph (b)(8)(ii) of this section and a 
summary of the results of technical data submitted under paragraph 
(b)(6) of this section. Such summary shall include a description of the 
objective of the study, a description of the experimental design of the 
study, a brief description of how the data were collected and analyzed, 
and a brief description of the results, whether positive, negative, or 
inconclusive. This section shall include the following:
    (A) A summary of the nonclinical laboratory studies submitted in the 
application;
    (B) A summary of the clinical investigations involving human 
subjects submitted in the application including a discussion of subject 
selection and exclusion criteria, study population, study period, safety 
and effectiveness data, adverse reactions and complications, patient 
discontinuation, patient complaints, device failures and replacements, 
results of statistical analyses of the clinical investigations, 
contraindications and precautions for use of the device, and other 
information from the clinical investigations as appropriate (any 
investigation conducted under an IDE shall be identified as such).
    (vi) Conclusions drawn from the studies. A discussion demonstrating 
that the data and information in the application constitute valid 
scientific evidence within the meaning of Sec. 860.7 and provide 
reasonable assurance that the device is safe and effective for its 
intended use. A concluding discussion shall present benefit and risk 
considerations related to the device including a discussion of any 
adverse effects of the device on health and any proposed additional 
studies or surveillance the applicant intends to conduct following 
approval of the PMA.
    (4) A complete description of:
    (i) The device, including pictorial representations;
    (ii) Each of the functional components or ingredients of the device 
if the device consists of more than one physical component or 
ingredient;
    (iii) The properties of the device relevant to the diagnosis, 
treatment, prevention, cure, or mitigation of a disease or condition;
    (iv) The principles of operation of the device; and
    (v) The methods used in, and the facilities and controls used for, 
the manufacture, processing, packing, storage, and, where appropriate, 
installation of the device, in sufficient detail so that a person 
generally familiar with current good manufacturing practice can make a 
knowledgeable judgment about the quality control used in the manufacture 
of the device.
    (5) Reference to any performance standard under section 514 of the 
act or the Radiation Control for Health and Safety Act of 1968 (42 
U.S.C. 263b et seq.) in effect or proposed at the time of the submission 
and to any voluntary standard that is relevant to any aspect of the 
safety or effectiveness of the device and that is known to or that 
should reasonably be known to the applicant. The applicant shall--
    (i) Provide adequate information to demonstrate how the device 
meets, or justify any deviation from, any performance standard 
established under

[[Page 121]]

section 514 of the act or under the Radiation Control for Health and 
Safety Act, and
    (ii) Explain any deviation from a voluntary standard.
    (6) The following technical sections which shall contain data and 
information in sufficient detail to permit FDA to determine whether to 
approve or deny approval of the application:
    (i) A section containing results of the nonclinical laboratory 
studies with the device including microbiological, toxicological, 
immunological, biocompatibility, stress, wear, shelf life, and other 
laboratory or animal tests as appropriate. Information on nonclinical 
laboratory studies shall include a statement that each such study was 
conducted in compliance with part 58, or, if the study was not conducted 
in compliance with such regulations, a brief statement of the reason for 
the noncompliance.
    (ii) A section containing results of the clinical investigations 
involving human subjects with the device including clinical protocols, 
number of investigators and subjects per investigator, subject selection 
and exclusion criteria, study population, study period, safety and 
effectiveness data, adverse reactions and complications, patient 
discontinuation, patient complaints, device failures and replacements, 
tabulations of data from all individual subject report forms and copies 
of such forms for each subject who died during a clinical investigation 
or who did not complete the investigation, results of statistical 
analyses of the clinical investigations, device failures and 
replacements, contraindications and precautions for use of the device, 
and any other appropriate information from the clinical investigations. 
Any investigation conducted under an IDE shall be identified as such. 
Information on clinical investigations involving human subjects shall 
include the following:
    (A) A statement with respect to each study that it either was 
conducted in compliance with the institutional review board regulations 
in part 56, or was not subject to the regulations under Sec. 56.104 or 
Sec. 56.105, and that it was conducted in compliance with the informed 
consent regulations in part 50; or if the study was not conducted in 
compliance with those regulations, a brief statement of the reason for 
the noncompliance.
    (B) A statement that each study was conducted in compliance with 
part 812 or part 813 concerning sponsors of clinical investigations and 
clinical investigators, or if the study was not conducted in compliance 
with those regulations, a brief statement of the reason for the 
noncompliance.
    (7) For a PMA supported solely by data from one investigation, a 
justification showing that data and other information from a single 
investigator are sufficient to demonstrate the safety and effectiveness 
of the device and to ensure reproducibility of test results.
    (8)(i) A bibliography of all published reports not submitted under 
paragraph (b)(6) of this section, whether adverse or supportive, known 
to or that should reasonably be known to the applicant and that concern 
the safety or effectiveness of the device.
    (ii) An identification, discussion, and analysis of any other data, 
information, or report relevant to an evaluation of the safety and 
effectiveness of the device known to or that should reasonably be known 
to the applicant from any source, foreign or domestic, including 
information derived from investigations other than those proposed in the 
application and from commercial marketing experience.
    (iii) Copies of such published reports or unpublished information in 
the possession of or reasonably obtainable by the applicant if an FDA 
advisory committee or FDA requests.
    (9) One or more samples of the device and its components, if 
requested by FDA. If it is impractical to submit a requested sample of 
the device, the applicant shall name the location at which FDA may 
examine and test one or more devices.
    (10) Copies of all proposed labeling for the device. Such labeling 
may include, e.g., instructions for installation and any information, 
literature, or advertising that constitutes labeling under section 
201(m) of the act.
    (11) An environmental assessment under Sec. 25.20(n) prepared in the 
applicable format in Sec. 25.40, unless the action qualifies for 
exclusion under Sec. 25.30 or

[[Page 122]]

Sec. 25.34. If the applicant believes that the action qualifies for 
exclusion, the PMA shall under Sec. 25.15(a) and (d) provide information 
that establishes to FDA's satisfaction that the action requested is 
included within the excluded category and meets the criteria for the 
applicable exclusion.
    (12) A financial certification or disclosure statement or both as 
required by part 54 of this chapter.
    (13) Such other information as FDA may request. If necessary, FDA 
will obtain the concurrence of the appropriate FDA advisory committee 
before requesting additional information.
    (c) Pertinent information in FDA files specifically referred to by 
an applicant may be incorporated into a PMA by reference. Information in 
a master file or other information submitted to FDA by a person other 
than the applicant will not be considered part of a PMA unless such 
reference is authorized in writing by the person who submitted the 
information or the master file. If a master file is not referenced 
within 5 years after the date that it is submitted to FDA, FDA will 
return the master file to the person who submitted it.
    (d) If the applicant believes that certain information required 
under paragraph (b) of this section to be in a PMA is not applicable to 
the device that is the subject of the PMA, and omits any such 
information from its PMA, the applicant shall submit a statement that 
identifies the omitted information and justifies the omission. The 
statement shall be submitted as a separate section in the PMA and 
identified in the table of contents. If the justification for the 
omission is not accepted by the agency, FDA will so notify the 
applicant.
    (e) The applicant shall periodically update its pending application 
with new safety and effectiveness information learned about the device 
from ongoing or completed studies that may reasonably affect an 
evaluation of the safety or effectiveness of the device or that may 
reasonably affect the statement of contraindications, warnings, 
precautions, and adverse reactions in the draft labeling. The update 
report shall be consistent with the data reporting provisions of the 
protocol. The applicant shall submit three copies of any update report 
and shall include in the report the number assigned by FDA to the PMA. 
These updates are considered to be amendments to the PMA. The time frame 
for review of a PMA will not be extended due to the submission of an 
update report unless the update is a major amendment under 
Sec. 814.37(c)(1). The applicant shall submit these reports--
    (1) 3 months after the filing date,
    (2) Following receipt of an approvable letter, and
    (3) At any other time as requested by FDA.
    (f) If a color additive subject to section 706 of the act is used in 
or on the device and has not previously been listed for such use, then, 
in lieu of submitting a color additive petition under part 71, at the 
option of the applicant, the information required to be submitted under 
part 71 may be submitted as part of the PMA. When submitted as part of 
the PMA, the information shall be submitted in three copies each bound 
in one or more numbered volumes of reasonable size. A PMA for a device 
that contains a color additive that is subject to section 706 of the act 
will not be approved until the color additive is listed for use in or on 
the device.
    (g) FDA has issued a PMA guideline to assist the applicant in the 
arrangement and content of a PMA. This guideline is available upon 
request from the Center for Devices and Radiological Health, Division of 
Small Manufacturers Assistance (HFZ-220), 1350 Piccard Dr. Rockville, MD 
20850, FAX 301-443-8818.
    (h) If you are sending a PMA, PMA amendment, PMA supplement, or 
correspondence with respect to a PMA, you must send it to the Document 
Mail Center (HFZ-401), Center for Devices and Radiological Health, Food 
and Drug Administration, 9200 Corporate Blvd., Rockville, MD 20850.

(Approved by the Office of Management and Budget under control number 
0910-0231)

[51 FR 26364, July 22, 1986; 51 FR 40415, Nov. 7, 1986, as amended at 51 
FR 43344, Dec. 2, 1986; 55 FR 11169, Mar. 27, 1990; 62 FR 40600, July 
29, 1997; 63 FR 5253, Feb. 2, 1998; 65 FR 17137, Mar. 31, 2000]

[[Page 123]]



Sec. 814.37  PMA amendments and resubmitted PMA's.

    (a) An applicant may amend a pending PMA or PMA supplement to revise 
existing information or provide additional information.
    (b) FDA may request the applicant to amend a PMA or PMA supplement 
with any information regarding the device that is necessary for FDA or 
the appropriate advisory committee to complete the review of the PMA or 
PMA supplement.
    (c) A PMA amendment submitted to FDA shall include the PMA or PMA 
supplement number assigned to the original submission and, if submitted 
on the applicant's own initiative, the reason for submitting the 
amendment. FDA may extend the time required for its review of the PMA, 
or PMA supplement, as follows:
    (1) If the applicant on its own initiative or at FDA's request 
submits a major PMA amendment (e.g., an amendment that contains 
significant new data from a previously unreported study, significant 
updated data from a previously reported study, detailed new analyses of 
previously submitted data, or significant required information 
previously omitted), the review period may be extended up to 180 days.
    (2) If an applicant declines to submit a major amendment requested 
by FDA, the review period may be extended for the number of days that 
elapse between the date of such request and the date that FDA receives 
the written response declining to submit the requested amendment.
    (d) An applicant may on its own initiative withdraw a PMA or PMA 
supplement. If FDA requests an applicant to submit a PMA amendment and a 
written response to FDA's request is not received within 180 days of the 
date of the request, FDA will consider the pending PMA or PMA supplement 
to be withdrawn voluntarily by the applicant.
    (e) An applicant may resubmit a PMA or PMA supplement after 
withdrawing it or after it is considered withdrawn under paragraph (d) 
of this section, or after FDA has refused to accept it for filing, or 
has denied approval of the PMA or PMA supplement. A resubmitted PMA or 
PMA supplement shall comply with the requirements of Sec. 814.20 or 
Sec. 814.39, respectively, and shall include the PMA number assigned to 
the original submission and the applicant's reasons for resubmission of 
the PMA or PMA supplement.



Sec. 814.39  PMA supplements.

    (a) After FDA's approval of a PMA, an applicant shall submit a PMA 
supplement for review and approval by FDA before making a change 
affecting the safety or effectiveness of the device for which the 
applicant has an approved PMA, unless the change is of a type for which 
FDA, under paragraph (e) of this section, has advised that an alternate 
submission is permitted or is of a type which, under section 
515(d)(6)(A) of the act and paragraph (f) of this section, does not 
require a PMA supplement under this paragraph. While the burden for 
determining whether a supplement is required is primarily on the PMA 
holder, changes for which an applicant shall submit a PMA supplement 
include, but are not limited to, the following types of changes if they 
affect the safety or effectiveness of the device:
    (1) New indications for use of the device.
    (2) Labeling changes.
    (3) The use of a different facility or establishment to manufacture, 
process, or package the device.
    (4) Changes in sterilization procedures.
    (5) Changes in packaging.
    (6) Changes in the performance or design specifications, circuits, 
components, ingredients, principle of operation, or physical layout of 
the device.
    (7) Extension of the expiration date of the device based on data 
obtained under a new or revised stability or sterility testing protocol 
that has not been approved by FDA. If the protocol has been approved, 
the change shall be reported to FDA under paragraph (b) of this section.
    (b) An applicant may make a change in a device after FDA's approval 
of a PMA for the device without submitting a PMA supplement if the 
change does not affect the device's safety or effectiveness and the 
change is reported to FDA in postapproval periodic reports

[[Page 124]]

required as a condition to approval of the device, e.g., an editorial 
change in labeling which does not affect the safety or effectiveness of 
the device.
    (c) All procedures and actions that apply to an application under 
Sec. 814.20 also apply to PMA supplements except that the information 
required in a supplement is limited to that needed to support the 
change. A summary under Sec. 814.20(b)(3) is required for only a 
supplement submitted for new indications for use of the device, 
significant changes in the performance or design specifications, 
circuits, components, ingredients, principles of operation, or physical 
layout of the device, or when otherwise required by FDA. The applicant 
shall submit three copies of a PMA supplement and shall include 
information relevant to the proposed changes in the device. A PMA 
supplement shall include a separate section that identifies each change 
for which approval is being requested and explains the reason for each 
such change. The applicant shall submit additional copies and additional 
information if requested by FDA. The time frames for review of, and FDA 
action on, a PMA supplement are the same as those provided in 
Sec. 814.40 for a PMA.
    (d)(1) After FDA approves a PMA, any change described in paragraph 
(d)(2) of this section that enhances the safety of the device or the 
safety in the use of the device may be placed into effect by the 
applicant prior to the receipt under Sec. 814.17 of a written FDA order 
approving the PMA supplement provided that:
    (i) The PMA supplement and its mailing cover are plainly marked 
``Special PMA Supplement--Changes Being Effected'';
    (ii) The PMA supplement provides a full explanation of the basis for 
the changes;
    (iii) The applicant has received acknowledgement from FDA of receipt 
of the supplement; and
    (iv) The PMA supplement specifically identifies the date that such 
changes are being effected.
    (2) The following changes are permitted by paragraph (d)(1) of this 
section:
    (i) Labeling changes that add or strengthen a contraindication, 
warning, precaution, or information about an adverse reaction.
    (ii) Labeling changes that add or strengthen an instruction that is 
intended to enhance the safe use of the device.
    (iii) Labeling changes that delete misleading, false, or unsupported 
indications.
    (iv) Changes in quality controls or manufacturing process that add a 
new specification or test method, or otherwise provide additional 
assurance of purity, identity, strength, or reliability of the device.
    (e) FDA will identify a change to a device for which an applicant 
has an approved PMA and for which a PMA supplement under paragraph (a) 
is not required. FDA will identify such a change in an advisory opinion 
under Sec. 10.85, if the change applies to a generic type of device, or 
in correspondence to the applicant, if the change applies only to the 
applicant's device. FDA will require that a change for which a PMA 
supplement under paragraph (a) is not required be reported to FDA in--
    (1) A periodic report under Sec. 814.84 or
    (2) A 30-day PMA supplement under this paragraph.
    (f) Under section 515(d) of the act, modifications to manufacturing 
procedures or methods of manufacture that affect the safety and 
effectiveness of a device subject to an approved PMA do not require 
submission of a PMA supplement under paragraph (a) of this section and 
are eligible to be the subject of a 30-day notice. A 30-day notice shall 
describe in detail the change, summarize the data or information 
supporting the change, and state that the change has been made in 
accordance with the requirements of part 820 of this chapter. The 
manufacturer may distribute the device 30 days after the date on which 
FDA receives the 30-day notice, unless FDA notifies the applicant within 
30 days from receipt of the notice that the notice is not adequate. If 
the notice is not adequate, FDA shall inform the applicant in writing 
that a 135-day PMA supplement is needed and shall describe what further 
information or action is required for acceptance of such change. The 
number of days under

[[Page 125]]

review as a 30-day notice shall be deducted from the 135-day PMA 
supplement review period if the notice meets appropriate content 
requirements for a PMA supplement.

FDA will identify, in the advisory opinion or correspondence, the type 
of information that is to be included in the report or 30-day PMA 
supplement. lf the change is required to be reported to FDA in a 
periodic report, the change may be made before it is reported to FDA. If 
the change is required to be reported in a 30-day PMA supplement, the 
change may be made 30 days after FDA files the 30-day PMA supplement 
unless FDA requires the PMA holder to provide additional information, 
informs the PMA holder that the supplement is not approvable, or 
disapproves the supplement. The 30-day PMA supplement shall follow the 
instructions in the correspondence or advisory opinion. Any 30-day PMA 
supplement that does not meet the requirements of the correspondence or 
advisory opinion will not be filed and, therefore, will not be deemed 
approved 30 days after receipt.

(Approved by the Office of Management and Budget under control number 
0910-0231)

[51 FR 26364, July 22, 1986, as amended at 51 FR 43344, Dec. 2, 1986; 63 
FR 54044, Oct. 8, 1998]



                     Subpart C--FDA Action on a PMA



Sec. 814.40  Time frames for reviewing a PMA.

    Within 180 days after receipt of an application that is accepted for 
filing and to which the applicant does not submit a major amendment, FDA 
will review the PMA and, after receiving the report and recommendation 
of the appropriate FDA advisory committee, send the applicant an 
approval order under Sec. 814.44(d), an approvable letter under 
Sec. 814.44(e), a not approvable letter under Sec. 814.44(f), or an 
order denying approval under Sec. 814.45. The approvable letter and the 
not approvable letter will provide an opportunity for the applicant to 
amend or withdraw the application, or to consider the letter to be a 
denial of approval of the PMA under Sec. 814.45 and to request 
administrative review under section 515 (d)(3) and (g) of the act.



Sec. 814.42  Filing a PMA.

    (a) The filing of an application means that FDA has made a threshold 
determination that the application is sufficiently complete to permit a 
substantive review. Within 45 days after a PMA is received by FDA, the 
agency will notify the applicant whether the application has been filed.
    (b) If FDA does not find that any of the reasons in paragraph (e) of 
this section for refusing to file the PMA applies, the agency will file 
the PMA and will notify the applicant in writing of the filing. The 
notice will include the PMA reference number and the date FDA filed the 
PMA. The date of filing is the date that a PMA accepted for filing was 
received by the agency. The 180-day period for review of a PMA starts on 
the date of filing.
    (c) If FDA refuses to file a PMA, the agency will notify the 
applicant of the reasons for the refusal. This notice will identify the 
deficiencies in the application that prevent filing and will include the 
PMA reference number.
    (d) If FDA refuses to file the PMA, the applicant may:
    (1) Resubmit the PMA with additional information necessary to comply 
with the requirements of section 515(c)(1) (A)-(G) of the act and 
Sec. 814.20. A resubmitted PMA shall include the PMA reference number of 
the original submission. If the resubmitted PMA is accepted for filing, 
the date of filing is the date FDA receives the resubmission;
    (2) Request in writing within 10 working days of the date of receipt 
of the notice refusing to file the PMA, an informal conference with the 
Director of the Office of Device Evaluation to review FDA's decision not 
to file the PMA. FDA will hold the informal conference within 10 working 
days of its receipt of the request and will render its decision on 
filing within 5 working days after the informal conference. If, after 
the informal conference, FDA accepts the PMA for filing, the date of 
filing will be the date of the decision to accept the PMA for filing. If 
FDA does not reverse its decision not to file the

[[Page 126]]

PMA, the applicant may request reconsideration of the decision from the 
Director of the Center for Devices and Radiological Health. The 
Director's decision will constitute final administrative action for the 
purpose of judicial review.
    (e) FDA may refuse to file a PMA if any of the following applies:
    (1) The application is incomplete because it does not on its face 
contain all the information required under section 515(c)(1) (A)-(G) of 
the act;
    (2) The PMA does not contain each of the items required under 
Sec. 814.20 and justification for omission of any item is inadequate;
    (3) The applicant has a pending premarket notification under section 
510(k) of the act with respect to the same device, and FDA has not 
determined whether the device falls within the scope of Sec. 814.1(c).
    (4) The PMA contains a false statement of material fact.
    (5) The PMA is not accompanied by a statement of either 
certification or disclosure as required by part 54 of this chapter.

[51 FR 26364, July 22, 1986, as amended at 63 FR 5254, Feb. 2, 1998]



Sec. 814.44  Procedures for review of a PMA.

    (a) FDA will begin substantive review of a PMA after the PMA is 
accepted for filing under Sec. 814.42. FDA may refer the PMA to a panel 
on its own initiative, and will do so upon request of an applicant, 
unless FDA determines that the application substantially duplicates 
information previously reviewed by a panel. If FDA refers an application 
to a panel, FDA will forward the PMA, or relevant portions thereof, to 
each member of the appropriate FDA panel for review. During the review 
process, FDA may communicate with the applicant as set forth under 
Sec. 814.37(b), or with a panel to respond to questions that may be 
posed by panel members or to provide additional information to the 
panel. FDA will maintain a record of all communications with the 
applicant and with the panel.
    (b) The advisory committee shall submit a report to FDA which 
includes the committee's recommendation and the basis for such 
recommendation on the PMA. Before submission of this report, the 
committee shall hold a public meeting to review the PMA in accordance 
with part 14. This meeting may be held by a telephone conference under 
Sec. 14.22(g). The advisory committee report and recommendation may be 
in the form of a meeting transcript signed by the chairperson of the 
committee.
    (c) FDA will complete its review of the PMA and the advisory 
committee report and recommendation and, within the later of 180 days 
from the date of filing of the PMA under Sec. 814.42 or the number of 
days after the date of filing as determined under Sec. 814.37(c), issue 
an approval order under paragraph (d) of this section, an approvable 
letter under paragraph (e) of this section, a not approvable letter 
under paragraph (f) of this section, or an order denying approval of the 
application under Sec. 814.45(a).
    (d)(1) FDA will issue to the applicant an order approving a PMA if 
none of the reasons in Sec. 814.45 for denying approval of the 
application applies. FDA will approve an application on the basis of 
draft final labeling if the only deficiencies in the application concern 
editorial or similar minor deficiencies in the draft final labeling. 
Such approval will be conditioned upon the applicant incorporating the 
specified labeling changes exactly as directed and upon the applicant 
submitting to FDA a copy of the final printed labeling before marketing. 
FDA will also give the public notice of the order, including notice of 
and opportunity for any interested persons to request review under 
section 515(d)(3) of the act. The notice of approval will be placed on 
FDA's home page on the Internet (http://www.fda.gov), and it will state 
that a detailed summary of information respecting the safety and 
effectiveness of the device, which was the basis for the order approving 
the PMA, including information about any adverse effects of the device 
on health, is available on the Internet and has been placed on public 
display, and that copies are available upon request. FDA will publish in 
the Federal Register after each quarter a list of the approvals 
announced in that quarter. When a notice of approval is published, data 
and information in the PMA file will be

[[Page 127]]

available for public disclosure in accordance with Sec. 814.9.
    (2) A request for copies of the current PMA approvals and denials 
document and for copies of summaries of safety and effectiveness shall 
be sent in writing to the Dockets Management Branch (HFA-305), Food and 
Drug Administration, 12420 Parklawn Dr., rm. 1-23, Rockville, MD 20857.
    (e) FDA will send the applicant an approvable letter if the 
application substantially meets the requirements of this part and the 
agency believes it can approve the application if specific additional 
information is submitted or specific conditions are agreed to by the 
applicant.
    (1) The approvable letter will describe the information FDA requires 
to be provided by the applicant or the conditions the applicant is 
required to meet to obtain approval. For example, FDA may require, as a 
condition to approval:
    (i) The submission of certain information identified in the 
approvable letter, e.g., final labeling;
    (ii) An FDA inspection that finds the manufacturing facilities, 
methods, and controls in compliance with part 820 and, if applicable, 
that verifies records pertinent to the PMA;
    (iii) Restrictions imposed on the device under section 
515(d)(1)(B)(ii) or 520(e) of the act;
    (iv) Postapproval requirements as described in subpart E of this 
part.
    (2) In response to an approvable letter the applicant may:
    (i) Amend the PMA as requested in the approvable letter; or
    (ii) Consider the approvable letter to be a denial of approval of 
the PMA under Sec. 814.45 and request administrative review under 
section 515(d)(3) of the act by filing a petition in the form of a 
petition for reconsideration under Sec. 10.33; or
    (iii) Withdraw the PMA.
    (f) FDA will send the applicant a not approvable letter if the 
agency believes that the application may not be approved for one or more 
of the reasons given in Sec. 814.45(a). The not approvable letter will 
describe the deficiencies in the application, including each applicable 
ground for denial under section 515(d)(2) (A)-(E) of the act, and, where 
practical, will identify measures required to place the PMA in 
approvable form. In response to a not approvable letter, the applicant 
may:
    (1) Amend the PMA as requested in the not approvable letter (such an 
amendment will be considered a major amendment under Sec. 814.37(c)(1)); 
or
    (2) Consider the not approvable letter to be a denial of approval of 
the PMA under Sec. 814.45 and request administrative review under 
section 515(d)(3) of the act by filing a petition in the form of a 
petition for reconsideration under Sec. 10.33; or
    (3) Withdraw the PMA.
    (g) FDA will consider a PMA to have been withdrawn voluntarily if:
    (1) The applicant fails to respond in writing to a written request 
for an amendment within 180 days after the date FDA issues such request;
    (2) The applicant fails to respond in writing to an approvable or 
not approvable letter within 180 days after the date FDA issues such 
letter; or
    (3) The applicant submits a written notice to FDA that the PMA has 
been withdrawn.

[51 FR 26364, July 22, 1986, as amended at 57 FR 58403, Dec. 10, 1992; 
63 FR 4572, Jan. 30, 1998]



Sec. 814.45  Denial of approval of a PMA.

    (a) FDA may issue an order denying approval of a PMA if the 
applicant fails to follow the requirements of this part or if, upon the 
basis of the information submitted in the PMA or any other information 
before the agency, FDA determines that any of the grounds for denying 
approval of a PMA specified in section 515(d)(2) (A)-(E) of the act 
applies. In addition, FDA may deny approval of a PMA for any of the 
following reasons:
    (1) The PMA contains a false statement of material fact;
    (2) The device's proposed labeling does not comply with the 
requirements in part 801 or part 809;
    (3) The applicant does not permit an authorized FDA employee an 
opportunity to inspect at a reasonable time and in a reasonable manner 
the facilities, controls, and to have access to and to copy and verify 
all records pertinent to the application;

[[Page 128]]

    (4) A nonclinical laboratory study that is described in the PMA and 
that is essential to show that the device is safe for use under the 
conditions prescribed, recommended, or suggested in its proposed 
labeling, was not conducted in compliance with the good laboratory 
practice regulations in part 58 and no reason for the noncompliance is 
provided or, if it is, the differences between the practices used in 
conducting the study and the good laboratory practice regulations do not 
support the validity of the study; or
    (5) Any clinical investigation involving human subjects described in 
the PMA, subject to the institutional review board regulations in part 
56 or informed consent regulations in part 50, was not conducted in 
compliance with those regulations such that the rights or safety of 
human subjects were not adequately protected.
    (b) FDA will issue any order denying approval of the PMA in 
accordance with Sec. 814.17. The order will inform the applicant of the 
deficiencies in the PMA, including each applicable ground for denial 
under section 515(d)(2) of the act and the regulations under this part, 
and, where practical, will identify measures required to place the PMA 
in approvable form. The order will include a notice of an opportunity to 
request review under section 515(d)(3) of the act.
    (c) FDA will use the criteria specified in Sec. 860.7 to determine 
the safety and effectiveness of a device in deciding whether to approve 
or deny approval of a PMA. FDA may use information other than that 
submitted by the applicant in making such determination.
    (d)(1) FDA will give the public notice of an order denying approval 
of the PMA. The notice will be placed on the FDA's home page on the 
Internet (http://www.fda.gov), and it will state that a detailed summary 
of information respecting the safety and effectiveness of the device, 
including information about any adverse effects of the device on health, 
is available on the Internet and has been placed on public display and 
that copies are available upon request. FDA will publish in the Federal 
Register after each quarter a list of the denials announced in that 
quarter. When a notice of denial of approval is made publicly available, 
data and information in the PMA file will be available for public 
disclosure in accordance with Sec. 814.9.
    (2) A request for copies of the current PMA approvals and denials 
document and copies of summaries of safety and effectiveness shall be 
sent in writing to the Freedom of Information Staff (HFI-35), Food and 
Drug Administration, 5600 Fishers Lane, Rockville, MD 20857.
    (e) FDA will issue an order denying approval of a PMA after an 
approvable or not approvable letter has been sent and the applicant:
    (1) Submits a requested amendment but any ground for denying 
approval of the application under section 515(d)(2) of the act still 
applies; or
    (2) Notifies FDA in writing that the requested amendment will not be 
submitted; or
    (3) Petitions for review under section 515(d)(3) of the act by 
filing a petition in the form of a petition for reconsideration under 
Sec. 10.33.

[51 FR 26364, July 22, 1986, as amended at 63 FR 4572, Jan. 30, 1998]



Sec. 814.46  Withdrawal of approval of a PMA.

    (a) FDA may issue an order withdrawing approval of a PMA if, from 
any information available to the agency, FDA determines that:
    (1) Any of the grounds under section 515(e)(1) (A)-(G) of the act 
applies.
    (2) Any postapproval requirement imposed by the PMA approval order 
or by regulation has not been met.
    (3) A nonclinical laboratory study that is described in the PMA and 
that is essential to show that the device is safe for use under the 
conditions prescribed, recommended, or suggested in its proposed 
labeling, was not conducted in compliance with the good laboratory 
practice regulations in part 58 and no reason for the noncompliance is 
provided or, if it is, the differences between the practices used in 
conducting the study and the good laboratory practice regulations do not 
support the validity of the study.
    (4) Any clinical investigation involving human subjects described in 
the

[[Page 129]]

PMA, subject to the institutional review board regulations in part 56 or 
informed consent regulations in part 50, was not conducted in compliance 
with those regulations such that the rights or safety of human subjects 
were not adequately protected.
    (b)(1) FDA may seek advice on scientific matters from any 
appropriate FDA advisory committee in deciding whether to withdraw 
approval of a PMA.
    (2) FDA may use information other than that submitted by the 
applicant in deciding whether to withdraw approval of a PMA.
    (c) Before issuing an order withdrawing approval of a PMA, FDA will 
issue the holder of the approved application a notice of opportunity for 
an informal hearing under part 16.
    (d) If the applicant does not request a hearing or if after the part 
16 hearing is held the agency decides to proceed with the withdrawal, 
FDA will issue to the holder of the approved application an order 
withdrawing approval of the application. The order will be issued under 
Sec. 814.17, will state each ground for withdrawing approval, and will 
include a notice of an opportunity for administrative review under 
section 515(e)(2) of the act.
    (e) FDA will give the public notice of an order withdrawing approval 
of a PMA. The notice will be published in the Federal Register and will 
state that a detailed summary of information respecting the safety and 
effectiveness of the device, including information about any adverse 
effects of the device on health, has been placed on public display and 
that copies are available upon request. When a notice of withdrawal of 
approval is published, data and information in the PMA file will be 
available for public disclosure in accordance with Sec. 814.9.



Sec. 814.47  Temporary suspension of approval of a PMA.

    (a) Scope. (1) This section describes the procedures that FDA will 
follow in exercising its authority under section 515(e)(3) of the act 
(21 U.S.C. 360e(e)(3)). This authority applies to the original PMA, as 
well as any PMA supplement(s), for a medical device.
    (2) FDA will issue an order temporarily suspending approval of a PMA 
if FDA determines that there is a reasonable probability that continued 
distribution of the device would cause serious, adverse health 
consequences or death.
    (b) Regulatory hearing. (1) If FDA believes that there is a 
reasonable probability that the continued distribution of a device 
subject to an approved PMA would cause serious, adverse health 
consequences or death, FDA may initiate and conduct a regulatory hearing 
to determine whether to issue an order temporarily suspending approval 
of the PMA.
    (2) Any regulatory hearing to determine whether to issue an order 
temporarily suspending approval of a PMA shall be initiated and 
conducted by FDA pursuant to part 16 of this chapter. If FDA believes 
that immediate action to remove a dangerous device from the market is 
necessary to protect the public health, the agency may, in accordance 
with Sec. 16.60(h) of this chapter, waive, suspend, or modify any part 
16 procedure pursuant to Sec. 10.19 of this chapter.
    (3) FDA shall deem the PMA holder's failure to request a hearing 
within the timeframe specified by FDA in the notice of opportunity for 
hearing to be a waiver.
    (c) Temporary suspension order. If the PMA holder does not request a 
regulatory hearing or if, after the hearing, and after consideration of 
the administrative record of the hearing, FDA determines that there is a 
reasonable probability that the continued distribution of a device under 
an approved PMA would cause serious, adverse health consequences or 
death, the agency shall, under the authority of section 515(e)(3) of the 
act, issue an order to the PMA holder temporarily suspending approval of 
the PMA.
    (d) Permanent withdrawal of approval of the PMA. If FDA issues an 
order temporarily suspending approval of a PMA, the agency shall proceed 
expeditiously, but within 60 days, to hold a hearing on whether to 
permanently withdraw approval of the PMA in accordance with section 
515(e)(1) of the act and the procedures set out in Sec. 814.46.

[61 FR 15190, Apr. 5, 1996]

[[Page 130]]

Subpart D--Administrative Review  [Reserved]



                  Subpart E--Postapproval Requirements



Sec. 814.80  General.

    A device may not be manufactured, packaged, stored, labeled, 
distributed, or advertised in a manner that is inconsistent with any 
conditions to approval specified in the PMA approval order for the 
device.



Sec. 814.82  Postapproval requirements.

    (a) FDA may impose postapproval requirements in a PMA approval order 
or by regulation at the time of approval of the PMA or by regulation 
subsequent to approval. Postapproval requirements may include as a 
condition to approval of the device:
    (1) Restriction of the sale, distribution, or use of the device as 
provided by section 515(d)(1)(B)(ii) or 520(e) of the act.
    (2) Continuing evaluation and periodic reporting on the safety, 
effectiveness, and reliability of the device for its intended use. FDA 
will state in the PMA approval order the reason or purpose for such 
requirement and the number of patients to be evaluated and the reports 
required to be submitted.
    (3) Prominent display in the labeling of a device and in the 
advertising of any restricted device of warnings, hazards, or 
precautions important for the device's safe and effective use, including 
patient information, e.g., information provided to the patient on 
alternative modes of therapy and on risks and benefits associated with 
the use of the device.
    (4) Inclusion of identification codes on the device or its labeling, 
or in the case of an implant, on cards given to patients if necessary to 
protect the public health.
    (5) Maintenance of records that will enable the applicant to submit 
to FDA information needed to trace patients if such information is 
necessary to protect the public health. Under section 519(a)(4) of the 
act, FDA will require that the identity of any patient be disclosed in 
records maintained under this paragraph only to the extent required for 
the medical welfare of the individual, to determine the safety or 
effectiveness of the device, or to verify a record, report, or 
information submitted to the agency.
    (6) Maintenance of records for specified periods of time and 
organization and indexing of records into identifiable files to enable 
FDA to determine whether there is reasonable assurance of the continued 
safety and effectiveness of the device.
    (7) Submission to FDA at intervals specified in the approval order 
of periodic reports containing the information required by 
Sec. 814.84(b).
    (8) Batch testing of the device.
    (9) Such other requirements as FDA determines are necessary to 
provide reasonable assurance, or continued reasonable assurance, of the 
safety and effectiveness of the device.
    (b) An applicant shall grant to FDA access to any records and 
reports required under the provisions of this part, and shall permit 
authorized FDA employees to copy and verify such records and reports and 
to inspect at a reasonable time and in a reasonable manner all 
manufacturing facilities to verify that the device is being 
manufactured, stored, labeled, and shipped under approved conditions.
    (c) Failure to comply with any postapproval requirement constitutes 
a ground for withdrawal of approval of a PMA.

(Approved by the Office of Management and Budget under control number 
0910-0231)

[51 FR 26364, July 22, 1986, as amended at 51 FR 43344, Dec. 2, 1986]



Sec. 814.84  Reports.

    (a) The holder of an approved PMA shall comply with the requirements 
of part 803 and with any other requirements applicable to the device by 
other regulations in this subchapter or by order approving the device.
    (b) Unless FDA specifies otherwise, any periodic report shall:
    (1) Identify changes described in Sec. 814.39(a) and changes 
required to be reported to FDA under Sec. 814.39(b).
    (2) Contain a summary and bibliography of the following information 
not previously submitted as part of the PMA:

[[Page 131]]

    (i) Unpublished reports of data from any clinical investigations or 
nonclinical laboratory studies involving the device or related devices 
and known to or that reasonably should be known to the applicant.
    (ii) Reports in the scientific literature concerning the device and 
known to or that reasonably should be known to the applicant. If, after 
reviewing the summary and bibliography, FDA concludes that the agency 
needs a copy of the unpublished or published reports, FDA will notify 
the applicant that copies of such reports shall be submitted.

(Approved by the Office of Management and Budget under control number 
0910-0231)

[51 FR 26364, July 22, 1986, as amended at 51 FR 43344, Dec. 2, 1986]

Subparts F-G  [Reserved]



                   Subpart H--Humanitarian Use Devices

    Source: 61 FR 33244, June 26, 1996, unless otherwise noted.



Sec. 814.100  Purpose and scope.

    (a) This subpart H implements section 520(m) of the act. The purpose 
of section 520(m) is, to the extent consistent with the protection of 
the public health and safety and with ethical standards, to encourage 
the discovery and use of devices intended to benefit patients in the 
treatment or diagnosis of diseases or conditions that affect or are 
manifested in fewer than 4,000 individuals in the United States per 
year. This subpart provides procedures for obtaining:
    (1) HUD designation of a medical device; and
    (2) Marketing approval for the HUD notwithstanding the absence of 
reasonable assurance of effectiveness that would otherwise be required 
under sections 514 and 515 of the act.
    (b) Although a HUD may also have uses that differ from the 
humanitarian use, applicants seeking approval of any non-HUD use shall 
submit a PMA as required under Sec. 814.20, or a premarket notification 
as required under part 807 of this chapter.
    (c) Obtaining marketing approval for a HUD involves two steps:
    (1) Obtaining designation of the device as a HUD from FDA's Office 
of Orphan Products Development, and
    (2) Submitting an HDE to the Office of Device Evaluation (ODE), 
Center for Devices and Radiological Health (CDRH).
    (d) A person granted an exemption under section 520(m) of the act 
shall submit periodic reports as described in Sec. 814.126(b).
    (e) FDA may suspend or withdraw approval of an HDE after providing 
notice and an opportunity for an informal hearing.

[61 FR 33244, June 26, 1996, as amended at 63 FR 59220, Nov. 3, 1998]



Sec. 814.102  Designation of HUD status.

    (a) Request for designation. Prior to submitting an HDE application, 
the applicant shall submit a request for HUD designation to FDA's Office 
of Orphan Products Development. The request shall contain the following:
    (1) A statement that the applicant requests HUD designation for a 
rare disease or condition or a valid subset of a disease or condition 
which shall be identified with specificity;
    (2) The name and address of the applicant, the name of the 
applicant's primary contact person and/or resident agent, including 
title, address, and telephone number;
    (3) A description of the rare disease or condition for which the 
device is to be used, the proposed indication or indications for use of 
the device, and the reasons why such therapy is needed. If the device is 
proposed for an indication that represents a subset of a common disease 
or condition, a demonstration that the subset is medically plausible 
should be included;
    (4) A description of the device and a discussion of the scientific 
rationale for the use of the device for the rare disease or condition; 
and
    (5) Documentation, with appended authoritative references, to 
demonstrate that the device is designed to treat or diagnose a disease 
or condition that affects or is manifested in fewer than 4,000 people in 
the United States per year. If the device is for diagnostic purposes, 
the documentation must

[[Page 132]]

demonstrate that fewer than 4,000 patients per year would be subjected 
to diagnosis by the device in the United States. Authoritative 
references include literature citations in specialized medical journals, 
textbooks, specialized medical society proceedings, or governmental 
statistics publications. When no such studies or literature citations 
exist, the applicant may be able to demonstrate the prevalence of the 
disease or condition in the United States by providing credible 
conclusions from appropriate research or surveys.
    (b) FDA action. Within 45 days of receipt of a request for HUD 
designation, FDA will take one of the following actions:
    (1) Approve the request and notify the applicant that the device has 
been designated as a HUD based on the information submitted;
    (2) Return the request to the applicant pending further review upon 
submission of additional information. This action will ensue if the 
request is incomplete because it does not on its face contain all of the 
information required under Sec. 814.102(a). Upon receipt of this 
additional information, the review period may be extended up to 45 days; 
or
    (3) Disapprove the request for HUD designation based on a 
substantive review of the information submitted. FDA may disapprove a 
request for HUD designation if:
    (i) There is insufficient evidence to support the estimate that the 
disease or condition for which the device is designed to treat or 
diagnose affects or is manifested in fewer than 4,000 people in the 
United States per year;
    (ii) FDA determines that, for a diagnostic device, 4,000 or more 
patients in the United States would be subjected to diagnosis using the 
device per year; or
    (iii) FDA determines that the patient population defined in the 
request is not a medically plausible subset of a larger population.
    (c) Revocation of designation. FDA may revoke a HUD designation if 
the agency finds that:
    (1) The request for designation contained an untrue statement of 
material fact or omitted material information; or
    (2) Based on the evidence available, the device is not eligible for 
HUD designation.
    (d) Submission. The applicant shall submit two copies of a 
completed, dated, and signed request for HUD designation to: Office of 
Orphan Products Development (HF-35), Food and Drug Administration, 5600 
Fishers Lane, Rockville, MD 20857.



Sec. 814.104  Original applications.

    (a) United States applicant or representative. The applicant or an 
authorized representative shall sign the HDE. If the applicant does not 
reside or have a place of business within the United States, the HDE 
shall be countersigned by an authorized representative residing or 
maintaining a place of business in the United States and shall identify 
the representative's name and address.
    (b) Contents. Unless the applicant justifies an omission in 
accordance with paragraph (d) of this section, an HDE shall include:
    (1) A copy of or reference to the determination made by FDA's Office 
of Orphan Products Development (in accordance with Sec. 814.102) that 
the device qualifies as a HUD;
    (2) An explanation of why the device would not be available unless 
an HDE were granted and a statement that no comparable device (other 
than another HUD approved under this subpart or a device under an 
approved IDE) is available to treat or diagnose the disease or 
condition. The application also shall contain a discussion of the risks 
and benefits of currently available devices or alternative forms of 
treatment in the United States;
    (3) An explanation of why the probable benefit to health from the 
use of the device outweighs the risk of injury or illness from its use, 
taking into account the probable risks and benefits of currently 
available devices or alternative forms of treatment. Such explanation 
shall include a description, explanation, or theory of the underlying 
disease process or condition, and known or postulated mechanism(s) of 
action of the device in relation to the disease process or condition;
    (4) All of the information required to be submitted under 
Sec. 814.20(b), except that:

[[Page 133]]

    (i) In lieu of the summaries, conclusions, and results from clinical 
investigations required under Secs. 814.20(b)(3)(v)(B), (b)(3)(vi), and 
(b)(6)(ii), the applicant shall include the summaries, conclusions, and 
results of all clinical experience or investigations (whether adverse or 
supportive) reasonably obtainable by the applicant that are relevant to 
an assessment of the risks and probable benefits of the device; and
    (ii) In addition to the proposed labeling requirement set forth in 
Sec. 814.20(b)(10), the labeling shall bear the following statement: 
Humanitarian Device. Authorized by Federal law for use in the [treatment 
or diagnosis] of [specify disease or condition]. The effectiveness of 
this device for this use has not been demonstrated; and
    (5) The amount to be charged for the device and, if the amount is 
more than $250, a report by an independent certified public accountant, 
made in accordance with the Statement on Standards for Attestation 
established by the American Institute of Certified Public Accountants, 
or in lieu of such a report, an attestation by a responsible individual 
of the organization, verifying that the amount charged does not exceed 
the costs of the device's research, development, fabrication, and 
distribution. If the amount charged is $250 or less, the requirement for 
a report by an independent certified public accountant or an attestation 
by a responsible individual of the organization is waived.
    (c) Omission of information. If the applicant believes that certain 
information required under paragraph (b) of this section is not 
applicable to the device that is the subject of the HDE, and omits any 
such information from its HDE, the applicant shall submit a statement 
that identifies and justifies the omission. The statement shall be 
submitted as a separate section in the HDE and identified in the table 
of contents. If the justification for the omission is not accepted by 
the agency, FDA will so notify the applicant.
    (d) Address for submissions and correspondence. Copies of all 
original HDE's, amendments and supplements, as well as any 
correspondence relating to an HDE, shall be sent or delivered to the 
Document Mail Center (HFZ-401), Office of Device Evaluation, Center for 
Devices and Radiological Health, Food and Drug Administration, 9200 
Corporate Blvd., Rockville, MD 20850.

[61 FR 33244, June 26, 1996, as amended at 63 FR 59220, Nov. 3, 1998]



Sec. 814.106  HDE amendments and resubmitted HDE's.

    An HDE or HDE supplement may be amended or resubmitted upon an 
applicant's own initiative, or at the request of FDA, for the same 
reasons and in the same manner as prescribed for PMA's in Sec. 814.37, 
except that the timeframes set forth in Sec. 814.37(c)(1) and (d) do not 
apply. If FDA requests an HDE applicant to submit an HDE amendment, and 
a written response to FDA's request is not received within 75 days of 
the date of the request, FDA will consider the pending HDE or HDE 
supplement to be withdrawn voluntarily by the applicant. Furthermore, if 
the HDE applicant, on its own initiative or at FDA's request, submits a 
major amendment as described in Sec. 814.37(c)(1), the review period may 
be extended up to 75 days.

[63 FR 59220, Nov. 3, 1998]



Sec. 814.108  Supplemental applications.

    After FDA approval of an original HDE, an applicant shall submit 
supplements in accordance with the requirements for PMA's under 
Sec. 814.39, except that a request for a new indication for use of a HUD 
shall comply with requirements set forth in Sec. 814.110. The timeframes 
for review of, and FDA action on, an HDE supplement are the same as 
those provided in Sec. 814.114 for an HDE.

[63 FR 59220, Nov. 3, 1998]



Sec. 814.110  New indications for use.

    (a) An applicant seeking a new indication for use of a HUD approved 
under this subpart H shall obtain a new designation of HUD status in 
accordance with Sec. 814.102 and shall submit an original HDE in 
accordance with Sec. 814.104.
    (b) An application for a new indication for use made under 
Sec. 814.104 may incorporate by reference any information or data 
previously submitted to the agency under an HDE.

[[Page 134]]



Sec. 814.112  Filing an HDE.

    (a) The filing of an HDE means that FDA has made a threshold 
determination that the application is sufficiently complete to permit 
substantive review. Within 30 days from the date an HDE is received by 
FDA, the agency will notify the applicant whether the application has 
been filed. FDA may refuse to file an HDE if any of the following 
applies:
    (1) The application is incomplete because it does not on its face 
contain all the information required under Sec. 814.104(b);
    (2) FDA determines that there is a comparable device available 
(other than another HUD approved under this subpart or a device under an 
approved IDE) to treat or diagnose the disease or condition for which 
approval of the HUD is being sought; or
    (3) The application contains an untrue statement of material fact or 
omits material information.
    (4) The HDE is not accompanied by a statement of either 
certification or disclosure, or both, as required by part 54 of this 
chapter.
    (b) The provisions contained in Sec. 814.42(b), (c), and (d) 
regarding notification of filing decisions, filing dates, the start of 
the 75-day review period, and applicant's options in response to FDA 
refuse to file decisions shall apply to HDE's.

[61 FR 33244, June 26, 1996, as amended at 63 FR 5254, Feb. 2, 1998; 63 
FR 59221, Nov. 3, 1998]



Sec. 814.114  Timeframes for reviewing an HDE.

    Within 75 days after receipt of an HDE that is accepted for filing 
and to which the applicant does not submit a major amendment, FDA shall 
send the applicant an approval order, an approvable letter, a not 
approvable letter (under Sec. 814.116), or an order denying approval 
(under Sec. 814.118).

[63 FR 59221, Nov. 3, 1998]



Sec. 814.116  Procedures for review of an HDE.

    (a) Substantive review. FDA will begin substantive review of an HDE 
after the HDE is accepted for filing under Sec. 814.112. FDA may refer 
an original HDE application to a panel on its own initiative, and shall 
do so upon the request of an applicant, unless FDA determines that the 
application substantially duplicates information previously reviewed by 
a panel. If the HDE is referred to a panel, the agency shall follow the 
procedures set forth under Sec. 814.44, with the exception that FDA will 
complete its review of the HDE and the advisory committee report and 
recommendations within 75 days from receipt of an HDE that is accepted 
for filing under Sec. 814.112 or the date of filing as determined under 
Sec. 814.106, whichever is later. Within the later of these two 
timeframes, FDA will issue an approval order under paragraph (b) of this 
section, an approvable letter under paragraph (c) of this section, a not 
approvable letter under paragraph (d) of this section, or an order 
denying approval of the application under Sec. 814.118(a).
    (b) Approval order. FDA will issue to the applicant an order 
approving an HDE if none of the reasons in Sec. 814.118 for denying 
approval of the application applies. FDA will approve an application on 
the basis of draft final labeling if the only deficiencies in the 
application concern editorial or similar minor deficiencies in the draft 
final labeling. Such approval will be conditioned upon the applicant 
incorporating the specified labeling changes exactly as directed and 
upon the applicant submitting to FDA a copy of the final printed 
labeling before marketing. The notice of approval of an HDE will be 
published in the Federal Register in accordance with the rules and 
policies applicable to PMA's submitted under Sec. 814.20. Following the 
issuance of an approval order, data and information in the HDE file will 
be available for public disclosure in accordance with Sec. 814.9(b) 
through (h), as applicable.
    (c) Approvable letter. FDA will send the applicant an approvable 
letter if the application substantially meets the requirements of this 
subpart and the agency believes it can approve the application if 
specific additional information is submitted or specific conditions are 
agreed to by the applicant. The approvable letter will describe the 
information FDA requires to be provided by the applicant or the 
conditions the applicant is required to meet to obtain

[[Page 135]]

approval. For example, FDA may require as a condition to approval:
    (1) The submission of certain information identified in the 
approvable letter, e.g., final labeling;
    (2) Restrictions imposed on the device under section 520(e) of the 
act;
    (3) Postapproval requirements as described in subpart E of this 
part; and
    (4) An FDA inspection that finds the manufacturing facilities, 
methods, and controls in compliance with part 820 of this chapter and, 
if applicable, that verifies records pertinent to the HDE.
    (d) Not approvable letter. FDA will send the applicant a not 
approvable letter if the agency believes that the application may not be 
approved for one or more of the reasons given in Sec. 814.118. The not 
approvable letter will describe the deficiencies in the application and, 
where practical, will identify measures required to place the HDE in 
approvable form. The applicant may respond to the not approvable letter 
in the same manner as permitted for not approvable letters for PMA's 
under Sec. 814.44(f), with the exception that if a major HDE amendment 
is submitted, the review period may be extended up to 75 days.
    (e) FDA will consider an HDE to have been withdrawn voluntarily if:
    (1) The applicant fails to respond in writing to a written request 
for an amendment within 75 days after the date FDA issues such request;
    (2) The applicant fails to respond in writing to an approvable or 
not approvable letter within 75 days after the date FDA issues such 
letter; or
    (3) The applicant submits a written notice to FDA that the HDE has 
been withdrawn.

[61 FR 33244, June 26, 1996, as amended at 63 FR 59221, Nov. 3, 1998]



Sec. 814.118  Denial of approval or withdrawal of approval of an HDE.

    (a) FDA may deny approval or withdraw approval of an application if 
the applicant fails to meet the requirements of section 520(m) of the 
act or of this part, or of any condition of approval imposed by an IRB 
or by FDA, or any postapproval requirements imposed under Sec. 814.126. 
In addition, FDA may deny approval or withdraw approval of an 
application if, upon the basis of the information submitted in the HDE 
or any other information before the agency, FDA determines that:
    (1) There is a lack of a showing of reasonable assurance that the 
device is safe under the conditions of use prescribed, recommended, or 
suggested in the labeling thereof;
    (2) The device is ineffective under the conditions of use 
prescribed, recommended, or suggested in the labeling thereof;
    (3) The applicant has not demonstrated that there is a reasonable 
basis from which to conclude that the probable benefit to health from 
the use of the device outweighs the risk of injury or illness, taking 
into account the probable risks and benefits of currently available 
devices or alternative forms of treatment;
    (4) The application or a report submitted by or on behalf of the 
applicant contains an untrue statement of material fact, or omits 
material information;
    (5) The device's labeling does not comply with the requirements in 
part 801 or part 809 of this chapter;
    (6) A nonclinical laboratory study that is described in the HDE and 
that is essential to show that the device is safe for use under the 
conditions prescribed, recommended, or suggested in its proposed 
labeling, was not conducted in compliance with the good laboratory 
practice regulations in part 58 of this chapter and no reason for the 
noncompliance is provided or, if it is, the differences between the 
practices used in conducting the study and the good laboratory practice 
regulations do not support the validity of the study;
    (7) Any clinical investigation involving human subjects described in 
the HDE, subject to the institutional review board regulations in part 
56 of this chapter or the informed consent regulations in part 50 of 
this chapter, was not conducted in compliance with those regulations 
such that the rights or safety of human subjects were not adequately 
protected;
    (8) The applicant does not permit an authorized FDA employee an 
opportunity to inspect at a reasonable time and in a reasonable manner 
the facilities and controls, and to have access to

[[Page 136]]

and to copy and verify all records pertinent to the application; or
    (9) The device's HUD designation should be revoked in accordance 
with Sec. 814.102(c).
    (b) If FDA issues an order denying approval of an application, the 
agency will comply with the same notice and disclosure provisions 
required for PMA's under Sec. 814.45(b) and (d), as applicable.
    (c) FDA will issue an order denying approval of an HDE after an 
approvable or not approvable letter has been sent and the applicant:
    (1) Submits a requested amendment but any ground for denying 
approval of the application under Sec. 814.118(a) still applies;
    (2) Notifies FDA in writing that the requested amendment will not be 
submitted; or
    (3) Petitions for review under section 515(d)(3) of the act by 
filing a petition in the form of a petition for reconsideration under 
Sec. 10.33 of this chapter.
    (d) Before issuing an order withdrawing approval of an HDE, FDA will 
provide the applicant with notice and an opportunity for a hearing as 
required for PMA's under Sec. 814.46(c) and (d), and will provide the 
public with notice in accordance with Sec. 814.46(e), as applicable.

[61 FR 33244, June 26, 1996, as amended at 63 FR 59221, Nov. 3, 1998]



Sec. 814.120  Temporary suspension of approval of an HDE.

    An HDE or HDE supplement may be temporarily suspended for the same 
reasons and in the same manner as prescribed for PMA's in Sec. 814.47.

[63 FR 59221, Nov. 3, 1998]



Sec. 814.122  Confidentiality of data and information.

    (a) Requirement for disclosure. The ``HDE file'' includes all data 
and information submitted with or referenced in the HDE, any IDE 
incorporated into the HDE, any HDE amendment or supplement, any report 
submitted under Sec. 814.126, any master file, or any other related 
submission. Any record in the HDE file will be available for public 
disclosure in accordance with the provisions of this section and part 20 
of this chapter.
    (b) Extent of disclosure. Disclosure by FDA of the existence and 
contents of an HDE file shall be subject to the same rules that pertain 
to PMA's under Sec. 814.9(b) through (h), as applicable.



Sec. 814.124  Institutional Review Board requirements.

    (a) IRB approval. The HDE holder is responsible for ensuring that a 
HUD approved under this subpart is administered only in facilities 
having an Institutional Review Board (IRB) constituted and acting 
pursuant to part 56 of this chapter, including continuing review of use 
of the device. In addition, a HUD may be administered only if such use 
has been approved by the IRB located at the facility or by a similarly 
constituted IRB that has agreed to oversee such use and to which the 
local IRB has deferred in a letter to the HDE holder, signed by the IRB 
chair or an authorized designee. If, however, a physician in an 
emergency situation determines that approval from an IRB cannot be 
obtained in time to prevent serious harm or death to a patient, a HUD 
may be administered without prior approval by the IRB located at the 
facility or by a similarly constituted IRB that has agreed to oversee 
such use. In such an emergency situation, the physician shall, within 5 
days after the use of the device, provide written notification to the 
chairman of the IRB of such use. Such written notification shall include 
the identification of the patient involved, the date on which the device 
was used, and the reason for the use.
    (b) Withdrawal of IRB approval. A holder of an approved HDE shall 
notify FDA of any withdrawal of approval for the use of a HUD by a 
reviewing IRB within 5 working days after being notified of the 
withdrawal of approval.

[61 FR 33244, June 26, 1996, as amended at 63 FR 59221, Nov. 3, 1998]



Sec. 814.126  Postapproval requirements and reports.

    (a) An HDE approved under this subpart H shall be subject to the 
postapproval requirements and reports set forth under subpart E of this 
part, as applicable, with the exception of

[[Page 137]]

Sec. 814.82(a)(7). In addition, medical device reports submitted to FDA 
in compliance with the requirements of part 803 of this chapter shall 
also be submitted to the IRB of record.
    (b) In addition to the reports identified in paragraph (a) of this 
section, the holder of an approved HDE shall prepare and submit the 
following complete, accurate, and timely reports:
    (1) Periodic reports. An HDE applicant is required to submit reports 
in accordance with the approval order. Unless FDA specifies otherwise, 
any periodic report shall include:
    (i) An update of the information required under Sec. 814.102(a) in a 
separately bound volume;
    (ii) An update of the information required under Sec. 814.104(b)(2), 
(b)(3), and (b)(5);
    (iii) The number of devices that have been shipped or sold since 
initial marketing approval under this subpart H and, if the number 
shipped or sold exceeds 4,000, an explanation and estimate of the number 
of devices used per patient. If a single device is used on multiple 
patients, the applicant shall submit an estimate of the number of 
patients treated or diagnosed using the device together with an 
explanation of the basis for the estimate;
    (iv) Information describing the applicant's clinical experience with 
the device since the HDE was initially approved. This information shall 
include safety information that is known or reasonably should be known 
to the applicant, medical device reports made under part 8dd of this 
chapter, any data generated from the postmarketing studies, and 
information (whether published or unpublished) that is known or 
reasonably expected to be known by the applicant that may affect an 
evaluation of the safety of the device or that may affect the statement 
of contraindications, warnings, precautions, and adverse reactions in 
the device's labeling; and
    (v) A summary of any changes made to the device in accordance with 
supplements submitted under Sec. 814.108. If information provided in the 
periodic reports, or any other information in the possession of FDA, 
gives the agency reason to believe that a device raises public health 
concerns or that the criteria for exemption are no longer met, the 
agency may require the HDE holder to submit additional information to 
demonstrate continued compliance with the HDE requirements.
    (2) Other. An HDE holder shall maintain records of the names and 
addresses of the facilities to which the HUD has been shipped, 
correspondence with reviewing IRB's, as well as any other information 
requested by a reviewing IRB or FDA. Such records shall be maintained in 
accordance with the HDE approval order.

[61 FR 33244, June 26, 1996, as amended at 63 FR 59221, Nov. 3, 1998]



PART 820--QUALITY SYSTEM REGULATION--Table of Contents




                      Subpart A--General Provisions

Sec.
820.1  Scope.
820.3  Definitions.
820.5  Quality system.

                 Subpart B--Quality System Requirements

820.20  Management responsibility.
820.22  Quality audit.
820.25  Personnel.

                       Subpart C--Design Controls

820.30  Design controls.

                      Subpart D--Document Controls

820.40  Document controls.

                     Subpart E--Purchasing Controls

820.50  Purchasing controls.

               Subpart F--Identification and Traceability

820.60  Identification.
820.65  Traceability.

               Subpart G--Production and Process Controls

820.70  Production and process controls.
820.72  Inspection, measuring, and test equipment.
820.75  Process validation.

                    Subpart H--Acceptance Activities

820.80  Receiving, in-process, and finished device acceptance.
820.86  Acceptance status.

[[Page 138]]

                    Subpart I--Nonconforming Product

820.90  Nonconforming product.

               Subpart J--Corrective and Preventive Action

820.100  Corrective and preventive action.

                Subpart K--Labeling and Packaging Control

820.120  Device labeling.
820.130  Device packaging.

      Subpart L--Handling, Storage, Distribution, and Installation

820.140  Handling.
820.150  Storage.
820.160  Distribution.
820.170  Installation.

                           Subpart M--Records

820.180  General requirements.
820.181  Device master record.
820.184  Device history record.
820.186  Quality system record.
820.198  Complaint files.

                          Subpart N--Servicing

820.200  Servicing.

                    Subpart O--Statistical Techniques

820.250  Statistical techniques.

    Authority: 21 U.S.C. 351, 352, 360, 360c, 360d, 360e, 360h, 360i, 
360j, 360l, 371, 374, 381, 383.

    Source: 61 FR 52654, Oct. 7, 1996, unless otherwise noted.



                      Subpart A--General Provisions



Sec. 820.1  Scope.

    (a) Applicability. (1) Current good manufacturing practice (CGMP) 
requirements are set forth in this quality system regulation. The 
requirements in this part govern the methods used in, and the facilities 
and controls used for, the design, manufacture, packaging, labeling, 
storage, installation, and servicing of all finished devices intended 
for human use. The requirements in this part are intended to ensure that 
finished devices will be safe and effective and otherwise in compliance 
with the Federal Food, Drug, and Cosmetic Act (the act). This part 
establishes basic requirements applicable to manufacturers of finished 
medical devices. If a manufacturer engages in only some operations 
subject to the requirements in this part, and not in others, that 
manufacturer need only comply with those requirements applicable to the 
operations in which it is engaged. With respect to class I devices, 
design controls apply only to those devices listed in Sec. 820.30(a)(2). 
This regulation does not apply to manufacturers of components or parts 
of finished devices, but such manufacturers are encouraged to use 
appropriate provisions of this regulation as guidance. Manufacturers of 
human blood and blood components are not subject to this part, but are 
subject to part 606 of this chapter.
    (2) The provisions of this part shall be applicable to any finished 
device as defined in this part, intended for human use, that is 
manufactured, imported, or offered for import in any State or Territory 
of the United States, the District of Columbia, or the Commonwealth of 
Puerto Rico.
    (3) In this regulation the term ``where appropriate'' is used 
several times. When a requirement is qualified by ``where appropriate,'' 
it is deemed to be ``appropriate'' unless the manufacturer can document 
justification otherwise. A requirement is ``appropriate'' if 
nonimplementation could reasonably be expected to result in the product 
not meeting its specified requirements or the manufacturer not being 
able to carry out any necessary corrective action.
    (b) Limitations. The quality system regulation in this part 
supplements regulations in other parts of this chapter except where 
explicitly stated otherwise. In the event that it is impossible to 
comply with all applicable regulations, both in this part and in other 
parts of this chapter, the regulations specifically applicable to the 
device in question shall supersede any other generally applicable 
requirements.
    (c) Authority. Part 820 is established and issued under authority of 
sections 501, 502, 510, 513, 514, 515, 518, 519, 520, 522, 701, 704, 
801, 803 of the act (21 U.S.C. 351, 352, 360, 360c, 360d, 360e, 360h, 
360i, 360j, 360l, 371, 374, 381, 383). The failure to comply with any 
applicable provision in this part renders a device adulterated under 
section 501(h) of the act.

[[Page 139]]

Such a device, as well as any person responsible for the failure to 
comply, is subject to regulatory action.
    (d) Foreign manufacturers. If a manufacturer who offers devices for 
import into the United States refuses to permit or allow the completion 
of a Food and Drug Administration (FDA) inspection of the foreign 
facility for the purpose of determining compliance with this part, it 
shall appear for purposes of section 801(a) of the act, that the methods 
used in, and the facilities and controls used for, the design, 
manufacture, packaging, labeling, storage, installation, or servicing of 
any devices produced at such facility that are offered for import into 
the United States do not conform to the requirements of section 520(f) 
of the act and this part and that the devices manufactured at that 
facility are adulterated under section 501(h) of the act.

[61 FR 52654, Oct. 7, 1996, as amended at 65 FR 17136, Mar. 31, 2000]



Sec. 820.3  Definitions.

    (a) Act means the Federal Food, Drug, and Cosmetic Act, as amended 
(secs. 201-903, 52 Stat. 1040 et seq., as amended (21 U.S.C. 321-394)). 
All definitions in section 201 of the act shall apply to the regulations 
in this part.
    (b) Complaint means any written, electronic, or oral communication 
that alleges deficiencies related to the identity, quality, durability, 
reliability, safety, effectiveness, or performance of a device after it 
is released for distribution.
    (c) Component means any raw material, substance, piece, part, 
software, firmware, labeling, or assembly which is intended to be 
included as part of the finished, packaged, and labeled device.
    (d) Control number means any distinctive symbols, such as a 
distinctive combination of letters or numbers, or both, from which the 
history of the manufacturing, packaging, labeling, and distribution of a 
unit, lot, or batch of finished devices can be determined.
    (e) Design history file (DHF) means a compilation of records which 
describes the design history of a finished device.
    (f) Design input means the physical and performance requirements of 
a device that are used as a basis for device design.
    (g) Design output means the results of a design effort at each 
design phase and at the end of the total design effort. The finished 
design output is the basis for the device master record. The total 
finished design output consists of the device, its packaging and 
labeling, and the device master record.
    (h) Design review means a documented, comprehensive, systematic 
examination of a design to evaluate the adequacy of the design 
requirements, to evaluate the capability of the design to meet these 
requirements, and to identify problems.
    (i) Device history record (DHR) means a compilation of records 
containing the production history of a finished device.
    (j) Device master record (DMR) means a compilation of records 
containing the procedures and specifications for a finished device.
    (k) Establish means define, document (in writing or electronically), 
and implement.
    (l) Finished device means any device or accessory to any device that 
is suitable for use or capable of functioning, whether or not it is 
packaged, labeled, or sterilized.
    (m) Lot or batch means one or more components or finished devices 
that consist of a single type, model, class, size, composition, or 
software version that are manufactured under essentially the same 
conditions and that are intended to have uniform characteristics and 
quality within specified limits.
    (n) Management with executive responsibility means those senior 
employees of a manufacturer who have the authority to establish or make 
changes to the manufacturer's quality policy and quality system.
    (o) Manufacturer means any person who designs, manufactures, 
fabricates, assembles, or processes a finished device. Manufacturer 
includes but is not limited to those who perform the functions of 
contract sterilization, installation, relabeling, remanufacturing, 
repacking, or specification development, and initial distributors of 
foreign entities performing these functions.
    (p) Manufacturing material means any material or substance used in 
or used to facilitate the manufacturing process, a concomitant 
constituent, or a byproduct constituent produced during

[[Page 140]]

the manufacturing process, which is present in or on the finished device 
as a residue or impurity not by design or intent of the manufacturer.
    (q) Nonconformity means the nonfulfillment of a specified 
requirement.
    (r) Product means components, manufacturing materials, in- process 
devices, finished devices, and returned devices.
    (s) Quality means the totality of features and characteristics that 
bear on the ability of a device to satisfy fitness-for-use, including 
safety and performance.
    (t) Quality audit means a systematic, independent examination of a 
manufacturer's quality system that is performed at defined intervals and 
at sufficient frequency to determine whether both quality system 
activities and the results of such activities comply with quality system 
procedures, that these procedures are implemented effectively, and that 
these procedures are suitable to achieve quality system objectives.
    (u) Quality policy means the overall intentions and direction of an 
organization with respect to quality, as established by management with 
executive responsibility.
    (v) Quality system means the organizational structure, 
responsibilities, procedures, processes, and resources for implementing 
quality management.
    (w) Remanufacturer means any person who processes, conditions, 
renovates, repackages, restores, or does any other act to a finished 
device that significantly changes the finished device's performance or 
safety specifications, or intended use.
    (x) Rework means action taken on a nonconforming product so that it 
will fulfill the specified DMR requirements before it is released for 
distribution.
    (y) Specification means any requirement with which a product, 
process, service, or other activity must conform.
    (z) Validation means confirmation by examination and provision of 
objective evidence that the particular requirements for a specific 
intended use can be consistently fulfilled.
    (1) Process validation means establishing by objective evidence that 
a process consistently produces a result or product meeting its 
predetermined specifications.
    (2) Design validation means establishing by objective evidence that 
device specifications conform with user needs and intended use(s).
    (aa) Verification means confirmation by examination and provision of 
objective evidence that specified requirements have been fulfilled.



Sec. 820.5  Quality system.

    Each manufacturer shall establish and maintain a quality system that 
is appropriate for the specific medical device(s) designed or 
manufactured, and that meets the requirements of this part.



                 Subpart B--Quality System Requirements



Sec. 820.20  Management responsibility.

    (a) Quality policy. Management with executive responsibility shall 
establish its policy and objectives for, and commitment to, quality. 
Management with executive responsibility shall ensure that the quality 
policy is understood, implemented, and maintained at all levels of the 
organization.
    (b) Organization. Each manufacturer shall establish and maintain an 
adequate organizational structure to ensure that devices are designed 
and produced in accordance with the requirements of this part.
    (1) Responsibility and authority. Each manufacturer shall establish 
the appropriate responsibility, authority, and interrelation of all 
personnel who manage, perform, and assess work affecting quality, and 
provide the independence and authority necessary to perform these tasks.
    (2) Resources. Each manufacturer shall provide adequate resources, 
including the assignment of trained personnel, for management, 
performance of work, and assessment activities, including internal 
quality audits, to meet the requirements of this part.
    (3) Management representative. Management with executive 
responsibility shall appoint, and document such appointment of, a member 
of management who, irrespective of other responsibilities, shall have 
established authority over and responsibility for:

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    (i) Ensuring that quality system requirements are effectively 
established and effectively maintained in accordance with this part; and
    (ii) Reporting on the performance of the quality system to 
management with executive responsibility for review.
    (c) Management review. Management with executive responsibility 
shall review the suitability and effectiveness of the quality system at 
defined intervals and with sufficient frequency according to established 
procedures to ensure that the quality system satisfies the requirements 
of this part and the manufacturer's established quality policy and 
objectives. The dates and results of quality system reviews shall be 
documented.
    (d) Quality planning. Each manufacturer shall establish a quality 
plan which defines the quality practices, resources, and activities 
relevant to devices that are designed and manufactured. The manufacturer 
shall establish how the requirements for quality will be met.
    (e) Quality system procedures. Each manufacturer shall establish 
quality system procedures and instructions. An outline of the structure 
of the documentation used in the quality system shall be established 
where appropriate.



Sec. 820.22  Quality audit.

    Each manufacturer shall establish procedures for quality audits and 
conduct such audits to assure that the quality system is in compliance 
with the established quality system requirements and to determine the 
effectiveness of the quality system. Quality audits shall be conducted 
by individuals who do not have direct responsibility for the matters 
being audited. Corrective action(s), including a reaudit of deficient 
matters, shall be taken when necessary. A report of the results of each 
quality audit, and reaudit(s) where taken, shall be made and such 
reports shall be reviewed by management having responsibility for the 
matters audited. The dates and results of quality audits and reaudits 
shall be documented.



Sec. 820.25  Personnel.

    (a) General. Each manufacturer shall have sufficient personnel with 
the necessary education, background, training, and experience to assure 
that all activities required by this part are correctly performed.
    (b) Training. Each manufacturer shall establish procedures for 
identifying training needs and ensure that all personnel are trained to 
adequately perform their assigned responsibilities. Training shall be 
documented.
    (1) As part of their training, personnel shall be made aware of 
device defects which may occur from the improper performance of their 
specific jobs.
    (2) Personnel who perform verification and validation activities 
shall be made aware of defects and errors that may be encountered as 
part of their job functions.



                       Subpart C--Design Controls



Sec. 820.30  Design controls.

    (a) General. (1) Each manufacturer of any class III or class II 
device, and the class I devices listed in paragraph (a)(2) of this 
section, shall establish and maintain procedures to control the design 
of the device in order to ensure that specified design requirements are 
met.
    (2) The following class I devices are subject to design controls:
    (i) Devices automated with computer software; and
    (ii) The devices listed in the following chart.

------------------------------------------------------------------------
              Section                              Device
------------------------------------------------------------------------
868.6810..........................  Catheter, Tracheobronchial Suction.
878.4460..........................  Glove, Surgeon's.
880.6760..........................  Restraint, Protective.
892.5650..........................  System, Applicator, Radionuclide,
                                     Manual.
892.5740..........................  Source, Radionuclide Teletherapy.
------------------------------------------------------------------------

    (b) Design and development planning. Each manufacturer shall 
establish and maintain plans that describe or reference the design and 
development activities and define responsibility for implementation. The 
plans shall identify and describe the interfaces with different groups 
or activities that provide, or result in, input to the design and 
development process. The plans

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shall be reviewed, updated, and approved as design and development 
evolves.
    (c) Design input. Each manufacturer shall establish and maintain 
procedures to ensure that the design requirements relating to a device 
are appropriate and address the intended use of the device, including 
the needs of the user and patient. The procedures shall include a 
mechanism for addressing incomplete, ambiguous, or conflicting 
requirements. The design input requirements shall be documented and 
shall be reviewed and approved by a designated individual(s). The 
approval, including the date and signature of the individual(s) 
approving the requirements, shall be documented.
    (d) Design output. Each manufacturer shall establish and maintain 
procedures for defining and documenting design output in terms that 
allow an adequate evaluation of conformance to design input 
requirements. Design output procedures shall contain or make reference 
to acceptance criteria and shall ensure that those design outputs that 
are essential for the proper functioning of the device are identified. 
Design output shall be documented, reviewed, and approved before 
release. The approval, including the date and signature of the 
individual(s) approving the output, shall be documented.
    (e) Design review. Each manufacturer shall establish and maintain 
procedures to ensure that formal documented reviews of the design 
results are planned and conducted at appropriate stages of the device's 
design development. The procedures shall ensure that participants at 
each design review include representatives of all functions concerned 
with the design stage being reviewed and an individual(s) who does not 
have direct responsibility for the design stage being reviewed, as well 
as any specialists needed. The results of a design review, including 
identification of the design, the date, and the individual(s) performing 
the review, shall be documented in the design history file (the DHF).
    (f) Design verification. Each manufacturer shall establish and 
maintain procedures for verifying the device design. Design verification 
shall confirm that the design output meets the design input 
requirements. The results of the design verification, including 
identification of the design, method(s), the date, and the individual(s) 
performing the verification, shall be documented in the DHF.
    (g) Design validation. Each manufacturer shall establish and 
maintain procedures for validating the device design. Design validation 
shall be performed under defined operating conditions on initial 
production units, lots, or batches, or their equivalents. Design 
validation shall ensure that devices conform to defined user needs and 
intended uses and shall include testing of production units under actual 
or simulated use conditions. Design validation shall include software 
validation and risk analysis, where appropriate. The results of the 
design validation, including identification of the design, method(s), 
the date, and the individual(s) performing the validation, shall be 
documented in the DHF.
    (h) Design transfer. Each manufacturer shall establish and maintain 
procedures to ensure that the device design is correctly translated into 
production specifications.
    (i) Design changes. Each manufacturer shall establish and maintain 
procedures for the identification, documentation, validation or where 
appropriate verification, review, and approval of design changes before 
their implementation.
    (j) Design history file. Each manufacturer shall establish and 
maintain a DHF for each type of device. The DHF shall contain or 
reference the records necessary to demonstrate that the design was 
developed in accordance with the approved design plan and the 
requirements of this part.



                      Subpart D--Document Controls



Sec. 820.40  Document controls.

    Each manufacturer shall establish and maintain procedures to control 
all documents that are required by this part. The procedures shall 
provide for the following:
    (a) Document approval and distribution. Each manufacturer shall 
designate an individual(s) to review for adequacy and approve prior to 
issuance all documents established to meet the

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requirements of this part. The approval, including the date and 
signature of the individual(s) approving the document, shall be 
documented. Documents established to meet the requirements of this part 
shall be available at all locations for which they are designated, used, 
or otherwise necessary, and all obsolete documents shall be promptly 
removed from all points of use or otherwise prevented from unintended 
use.
    (b) Document changes. Changes to documents shall be reviewed and 
approved by an individual(s) in the same function or organization that 
performed the original review and approval, unless specifically 
designated otherwise. Approved changes shall be communicated to the 
appropriate personnel in a timely manner. Each manufacturer shall 
maintain records of changes to documents. Change records shall include a 
description of the change, identification of the affected documents, the 
signature of the approving individual(s), the approval date, and when 
the change becomes effective.



                     Subpart E--Purchasing Controls



Sec. 820.50  Purchasing controls.

    Each manufacturer shall establish and maintain procedures to ensure 
that all purchased or otherwise received product and services conform to 
specified requirements.
    (a) Evaluation of suppliers, contractors, and consultants. Each 
manufacturer shall establish and maintain the requirements, including 
quality requirements, that must be met by suppliers, contractors, and 
consultants. Each manufacturer shall:
    (1) Evaluate and select potential suppliers, contractors, and 
consultants on the basis of their ability to meet specified 
requirements, including quality requirements. The evaluation shall be 
documented.
    (2) Define the type and extent of control to be exercised over the 
product, services, suppliers, contractors, and consultants, based on the 
evaluation results.
    (3) Establish and maintain records of acceptable suppliers, 
contractors, and consultants.
    (b) Purchasing data. Each manufacturer shall establish and maintain 
data that clearly describe or reference the specified requirements, 
including quality requirements, for purchased or otherwise received 
product and services. Purchasing documents shall include, where 
possible, an agreement that the suppliers, contractors, and consultants 
agree to notify the manufacturer of changes in the product or service so 
that manufacturers may determine whether the changes may affect the 
quality of a finished device. Purchasing data shall be approved in 
accordance with Sec. 820.40.



               Subpart F--Identification and Traceability



Sec. 820.60  Identification.

    Each manufacturer shall establish and maintain procedures for 
identifying product during all stages of receipt, production, 
distribution, and installation to prevent mixups.



Sec. 820.65  Traceability.

    Each manufacturer of a device that is intended for surgical implant 
into the body or to support or sustain life and whose failure to perform 
when properly used in accordance with instructions for use provided in 
the labeling can be reasonably expected to result in a significant 
injury to the user shall establish and maintain procedures for 
identifying with a control number each unit, lot, or batch of finished 
devices and where appropriate components. The procedures shall 
facilitate corrective action. Such identification shall be documented in 
the DHR.



               Subpart G--Production and Process Controls



Sec. 820.70  Production and process controls.

    (a) General. Each manufacturer shall develop, conduct, control, and 
monitor production processes to ensure that a device conforms to its 
specifications. Where deviations from device specifications could occur 
as a result of the manufacturing process, the manufacturer shall 
establish and maintain

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process control procedures that describe any process controls necessary 
to ensure conformance to specifications. Where process controls are 
needed they shall include:
    (1) Documented instructions, standard operating procedures (SOP's), 
and methods that define and control the manner of production;
    (2) Monitoring and control of process parameters and component and 
device characteristics during production;
    (3) Compliance with specified reference standards or codes;
    (4) The approval of processes and process equipment; and
    (5) Criteria for workmanship which shall be expressed in documented 
standards or by means of identified and approved representative samples.
    (b) Production and process changes. Each manufacturer shall 
establish and maintain procedures for changes to a specification, 
method, process, or procedure. Such changes shall be verified or where 
appropriate validated according to Sec. 820.75, before implementation 
and these activities shall be documented. Changes shall be approved in 
accordance with Sec. 820.40.
    (c) Environmental control. Where environmental conditions could 
reasonably be expected to have an adverse effect on product quality, the 
manufacturer shall establish and maintain procedures to adequately 
control these environmental conditions. Environmental control system(s) 
shall be periodically inspected to verify that the system, including 
necessary equipment, is adequate and functioning properly. These 
activities shall be documented and reviewed.
    (d) Personnel. Each manufacturer shall establish and maintain 
requirements for the health, cleanliness, personal practices, and 
clothing of personnel if contact between such personnel and product or 
environment could reasonably be expected to have an adverse effect on 
product quality. The manufacturer shall ensure that maintenance and 
other personnel who are required to work temporarily under special 
environmental conditions are appropriately trained or supervised by a 
trained individual.
    (e) Contamination control. Each manufacturer shall establish and 
maintain procedures to prevent contamination of equipment or product by 
substances that could reasonably be expected to have an adverse effect 
on product quality.
    (f) Buildings. Buildings shall be of suitable design and contain 
sufficient space to perform necessary operations, prevent mixups, and 
assure orderly handling.
    (g) Equipment. Each manufacturer shall ensure that all equipment 
used in the manufacturing process meets specified requirements and is 
appropriately designed, constructed, placed, and installed to facilitate 
maintenance, adjustment, cleaning, and use.
    (1) Maintenance schedule. Each manufacturer shall establish and 
maintain schedules for the adjustment, cleaning, and other maintenance 
of equipment to ensure that manufacturing specifications are met. 
Maintenance activities, including the date and individual(s) performing 
the maintenance activities, shall be documented.
    (2) Inspection. Each manufacturer shall conduct periodic inspections 
in accordance with established procedures to ensure adherence to 
applicable equipment maintenance schedules. The inspections, including 
the date and individual(s) conducting the inspections, shall be 
documented.
    (3) Adjustment. Each manufacturer shall ensure that any inherent 
limitations or allowable tolerances are visibly posted on or near 
equipment requiring periodic adjustments or are readily available to 
personnel performing these adjustments.
    (h) Manufacturing material. Where a manufacturing material could 
reasonably be expected to have an adverse effect on product quality, the 
manufacturer shall establish and maintain procedures for the use and 
removal of such manufacturing material to ensure that it is removed or 
limited to an amount that does not adversely affect the device's 
quality. The removal or reduction of such manufacturing material shall 
be documented.
    (i) Automated processes. When computers or automated data processing 
systems are used as part of production or the quality system, the 
manufacturer shall validate computer software

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for its intended use according to an established protocol. All software 
changes shall be validated before approval and issuance. These 
validation activities and results shall be documented.



Sec. 820.72  Inspection, measuring, and test equipment.

    (a) Control of inspection, measuring, and test equipment. Each 
manufacturer shall ensure that all inspection, measuring, and test 
equipment, including mechanical, automated, or electronic inspection and 
test equipment, is suitable for its intended purposes and is capable of 
producing valid results. Each manufacturer shall establish and maintain 
procedures to ensure that equipment is routinely calibrated, inspected, 
checked, and maintained. The procedures shall include provisions for 
handling, preservation, and storage of equipment, so that its accuracy 
and fitness for use are maintained. These activities shall be 
documented.
    (b) Calibration. Calibration procedures shall include specific 
directions and limits for accuracy and precision. When accuracy and 
precision limits are not met, there shall be provisions for remedial 
action to reestablish the limits and to evaluate whether there was any 
adverse effect on the device's quality. These activities shall be 
documented.
    (1) Calibration standards. Calibration standards used for 
inspection, measuring, and test equipment shall be traceable to national 
or international standards. If national or international standards are 
not practical or available, the manufacturer shall use an independent 
reproducible standard. If no applicable standard exists, the 
manufacturer shall establish and maintain an in-house standard.
    (2) Calibration records. The equipment identification, calibration 
dates, the individual performing each calibration, and the next 
calibration date shall be documented. These records shall be displayed 
on or near each piece of equipment or shall be readily available to the 
personnel using such equipment and to the individuals responsible for 
calibrating the equipment.



Sec. 820.75  Process validation.

    (a) Where the results of a process cannot be fully verified by 
subsequent inspection and test, the process shall be validated with a 
high degree of assurance and approved according to established 
procedures. The validation activities and results, including the date 
and signature of the individual(s) approving the validation and where 
appropriate the major equipment validated, shall be documented.
    (b) Each manufacturer shall establish and maintain procedures for 
monitoring and control of process parameters for validated processes to 
ensure that the specified requirements continue to be met.
    (1) Each manufacturer shall ensure that validated processes are 
performed by qualified individual(s).
    (2) For validated processes, the monitoring and control methods and 
data, the date performed, and, where appropriate, the individual(s) 
performing the process or the major equipment used shall be documented.
    (c) When changes or process deviations occur, the manufacturer shall 
review and evaluate the process and perform revalidation where 
appropriate. These activities shall be documented.



                    Subpart H--Acceptance Activities



Sec. 820.80  Receiving, in-process, and finished device acceptance.

    (a) General. Each manufacturer shall establish and maintain 
procedures for acceptance activities. Acceptance activities include 
inspections, tests, or other verification activities.
    (b) Receiving acceptance activities. Each manufacturer shall 
establish and maintain procedures for acceptance of incoming product. 
Incoming product shall be inspected, tested, or otherwise verified as 
conforming to specified requirements. Acceptance or rejection shall be 
documented.
    (c) In-process acceptance activities. Each manufacturer shall 
establish and maintain acceptance procedures, where appropriate, to 
ensure that specified requirements for in-process product are met. Such 
procedures shall ensure that in-process product is controlled until the 
required inspection and tests or

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other verification activities have been completed, or necessary 
approvals are received, and are documented.
    (d) Final acceptance activities. Each manufacturer shall establish 
and maintain procedures for finished device acceptance to ensure that 
each production run, lot, or batch of finished devices meets acceptance 
criteria. Finished devices shall be held in quarantine or otherwise 
adequately controlled until released. Finished devices shall not be 
released for distribution until:
    (1) The activities required in the DMR are completed;
    (2) the associated data and documentation is reviewed;
    (3) the release is authorized by the signature of a designated 
individual(s); and
    (4) the authorization is dated.
    (e) Acceptance records. Each manufacturer shall document acceptance 
activities required by this part. These records shall include:
    (1) The acceptance activities performed;
    (2) the dates acceptance activities are performed;
    (3) the results;
    (4) the signature of the individual(s) conducting the acceptance 
activities; and
    (5) where appropriate the equipment used. These records shall be 
part of the DHR.



Sec. 820.86  Acceptance status.

    Each manufacturer shall identify by suitable means the acceptance 
status of product, to indicate the conformance or nonconformance of 
product with acceptance criteria. The identification of acceptance 
status shall be maintained throughout manufacturing, packaging, 
labeling, installation, and servicing of the product to ensure that only 
product which has passed the required acceptance activities is 
distributed, used, or installed.



                    Subpart I--Nonconforming Product



Sec. 820.90  Nonconforming product.

    (a) Control of nonconforming product. Each manufacturer shall 
establish and maintain procedures to control product that does not 
conform to specified requirements. The procedures shall address the 
identification, documentation, evaluation, segregation, and disposition 
of nonconforming product. The evaluation of nonconformance shall include 
a determination of the need for an investigation and notification of the 
persons or organizations responsible for the nonconformance. The 
evaluation and any investigation shall be documented.
    (b) Nonconformity review and disposition. (1) Each manufacturer 
shall establish and maintain procedures that define the responsibility 
for review and the authority for the disposition of nonconforming 
product. The procedures shall set forth the review and disposition 
process. Disposition of nonconforming product shall be documented. 
Documentation shall include the justification for use of nonconforming 
product and the signature of the individual(s) authorizing the use.
    (2) Each manufacturer shall establish and maintain procedures for 
rework, to include retesting and reevaluation of the nonconforming 
product after rework, to ensure that the product meets its current 
approved specifications. Rework and reevaluation activities, including a 
determination of any adverse effect from the rework upon the product, 
shall be documented in the DHR.



               Subpart J--Corrective and Preventive Action



Sec. 820.100  Corrective and preventive action.

    (a) Each manufacturer shall establish and maintain procedures for 
implementing corrective and preventive action. The procedures shall 
include requirements for:
    (1) Analyzing processes, work operations, concessions, quality audit 
reports, quality records, service records, complaints, returned product, 
and other sources of quality data to identify existing and potential 
causes of nonconforming product, or other quality problems. Appropriate 
statistical methodology shall be employed where necessary to detect 
recurring quality problems;

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    (2) Investigating the cause of nonconformities relating to product, 
processes, and the quality system;
    (3) Identifying the action(s) needed to correct and prevent 
recurrence of nonconforming product and other quality problems;
    (4) Verifying or validating the corrective and preventive action to 
ensure that such action is effective and does not adversely affect the 
finished device;
    (5) Implementing and recording changes in methods and procedures 
needed to correct and prevent identified quality problems;
    (6) Ensuring that information related to quality problems or 
nonconforming product is disseminated to those directly responsible for 
assuring the quality of such product or the prevention of such problems; 
and
    (7) Submitting relevant information on identified quality problems, 
as well as corrective and preventive actions, for management review.
    (b) All activities required under this section, and their results, 
shall be documented.



                Subpart K--Labeling and Packaging Control



Sec. 820.120  Device labeling.

    Each manufacturer shall establish and maintain procedures to control 
labeling activities.
    (a) Label integrity. Labels shall be printed and applied so as to 
remain legible and affixed during the customary conditions of 
processing, storage, handling, distribution, and where appropriate use.
    (b) Labeling inspection. Labeling shall not be released for storage 
or use until a designated individual(s) has examined the labeling for 
accuracy including, where applicable, the correct expiration date, 
control number, storage instructions, handling instructions, and any 
additional processing instructions. The release, including the date and 
signature of the individual(s) performing the examination, shall be 
documented in the DHR.
    (c) Labeling storage. Each manufacturer shall store labeling in a 
manner that provides proper identification and is designed to prevent 
mixups.
    (d) Labeling operations. Each manufacturer shall control labeling 
and packaging operations to prevent labeling mixups. The label and 
labeling used for each production unit, lot, or batch shall be 
documented in the DHR.
    (e) Control number. Where a control number is required by 
Sec. 820.65, that control number shall be on or shall accompany the 
device through distribution.



Sec. 820.130  Device packaging.

    Each manufacturer shall ensure that device packaging and shipping 
containers are designed and constructed to protect the device from 
alteration or damage during the customary conditions of processing, 
storage, handling, and distribution.



      Subpart L--Handling, Storage, Distribution, and Installation



Sec. 820.140  Handling.

    Each manufacturer shall establish and maintain procedures to ensure 
that mixups, damage, deterioration, contamination, or other adverse 
effects to product do not occur during handling.



Sec. 820.150  Storage.

    (a) Each manufacturer shall establish and maintain procedures for 
the control of storage areas and stock rooms for product to prevent 
mixups, damage, deterioration, contamination, or other adverse effects 
pending use or distribution and to ensure that no obsolete, rejected, or 
deteriorated product is used or distributed. When the quality of product 
deteriorates over time, it shall be stored in a manner to facilitate 
proper stock rotation, and its condition shall be assessed as 
appropriate.
    (b) Each manufacturer shall establish and maintain procedures that 
describe the methods for authorizing receipt from and dispatch to 
storage areas and stock rooms.



Sec. 820.160  Distribution.

    (a) Each manufacturer shall establish and maintain procedures for 
control and distribution of finished devices to ensure that only those 
devices approved for release are distributed and that purchase orders 
are reviewed to ensure that ambiguities and errors are

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resolved before devices are released for distribution. Where a device's 
fitness for use or quality deteriorates over time, the procedures shall 
ensure that expired devices or devices deteriorated beyond acceptable 
fitness for use are not distributed.
    (b) Each manufacturer shall maintain distribution records which 
include or refer to the location of:
    (1) The name and address of the initial consignee;
    (2) The identification and quantity of devices shipped;
    (3) The date shipped; and
    (4) Any control number(s) used.



Sec. 820.170  Installation.

    (a) Each manufacturer of a device requiring installation shall 
establish and maintain adequate installation and inspection 
instructions, and where appropriate test procedures. Instructions and 
procedures shall include directions for ensuring proper installation so 
that the device will perform as intended after installation. The 
manufacturer shall distribute the instructions and procedures with the 
device or otherwise make them available to the person(s) installing the 
device.
    (b) The person installing the device shall ensure that the 
installation, inspection, and any required testing are performed in 
accordance with the manufacturer's instructions and procedures and shall 
document the inspection and any test results to demonstrate proper 
installation.



                           Subpart M--Records



Sec. 820.180  General requirements.

    All records required by this part shall be maintained at the 
manufacturing establishment or other location that is reasonably 
accessible to responsible officials of the manufacturer and to employees 
of FDA designated to perform inspections. Such records, including those 
not stored at the inspected establishment, shall be made readily 
available for review and copying by FDA employee(s). Such records shall 
be legible and shall be stored to minimize deterioration and to prevent 
loss. Those records stored in automated data processing systems shall be 
backed up.
    (a) Confidentiality. Records deemed confidential by the manufacturer 
may be marked to aid FDA in determining whether information may be 
disclosed under the public information regulation in part 20 of this 
chapter.
    (b) Record retention period. All records required by this part shall 
be retained for a period of time equivalent to the design and expected 
life of the device, but in no case less than 2 years from the date of 
release for commercial distribution by the manufacturer.
    (c) Exceptions. This section does not apply to the reports required 
by Sec. 820.20(c) Management review, Sec. 820.22 Quality audits, and 
supplier audit reports used to meet the requirements of Sec. 820.50(a) 
Evaluation of suppliers, contractors, and consultants, but does apply to 
procedures established under these provisions. Upon request of a 
designated employee of FDA, an employee in management with executive 
responsibility shall certify in writing that the management reviews and 
quality audits required under this part, and supplier audits where 
applicable, have been performed and documented, the dates on which they 
were performed, and that any required corrective action has been 
undertaken.



Sec. 820.181  Device master record.

    Each manufacturer shall maintain device master records (DMR's). Each 
manufacturer shall ensure that each DMR is prepared and approved in 
accordance with Sec. 820.40. The DMR for each type of device shall 
include, or refer to the location of, the following information:
    (a) Device specifications including appropriate drawings, 
composition, formulation, component specifications, and software 
specifications;
    (b) Production process specifications including the appropriate 
equipment specifications, production methods, production procedures, and 
production environment specifications;
    (c) Quality assurance procedures and specifications including 
acceptance criteria and the quality assurance equipment to be used;
    (d) Packaging and labeling specifications, including methods and 
processes used; and

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    (e) Installation, maintenance, and servicing procedures and methods.



Sec. 820.184  Device history record.

    Each manufacturer shall maintain device history records (DHR's). 
Each manufacturer shall establish and maintain procedures to ensure that 
DHR's for each batch, lot, or unit are maintained to demonstrate that 
the device is manufactured in accordance with the DMR and the 
requirements of this part. The DHR shall include, or refer to the 
location of, the following information:
    (a) The dates of manufacture;
    (b) The quantity manufactured;
    (c) The quantity released for distribution;
    (d) The acceptance records which demonstrate the device is 
manufactured in accordance with the DMR;
    (e) The primary identification label and labeling used for each 
production unit; and
    (f) Any device identification(s) and control number(s) used.



Sec. 820.186  Quality system record.

    Each manufacturer shall maintain a quality system record (QSR). The 
QSR shall include, or refer to the location of, procedures and the 
documentation of activities required by this part that are not specific 
to a particular type of device(s), including, but not limited to, the 
records required by Sec. 820.20. Each manufacturer shall ensure that the 
QSR is prepared and approved in accordance with Sec. 820.40.



Sec. 820.198  Complaint files.

    (a) Each manufacturer shall maintain complaint files. Each 
manufacturer shall establish and maintain procedures for receiving, 
reviewing, and evaluating complaints by a formally designated unit. Such 
procedures shall ensure that:
    (1) All complaints are processed in a uniform and timely manner;
    (2) Oral complaints are documented upon receipt; and
    (3) Complaints are evaluated to determine whether the complaint 
represents an event which is required to be reported to FDA under part 
803 or 804 of this chapter, Medical Device Reporting.
    (b) Each manufacturer shall review and evaluate all complaints to 
determine whether an investigation is necessary. When no investigation 
is made, the manufacturer shall maintain a record that includes the 
reason no investigation was made and the name of the individual 
responsible for the decision not to investigate.
    (c) Any complaint involving the possible failure of a device, 
labeling, or packaging to meet any of its specifications shall be 
reviewed, evaluated, and investigated, unless such investigation has 
already been performed for a similar complaint and another investigation 
is not necessary.
    (d) Any complaint that represents an event which must be reported to 
FDA under part 803 or 804 of this chapter shall be promptly reviewed, 
evaluated, and investigated by a designated individual(s) and shall be 
maintained in a separate portion of the complaint files or otherwise 
clearly identified. In addition to the information required by 
Sec. 820.198(e), records of investigation under this paragraph shall 
include a determination of:
    (1) Whether the device failed to meet specifications;
    (2) Whether the device was being used for treatment or diagnosis; 
and
    (3) The relationship, if any, of the device to the reported incident 
or adverse event.
    (e) When an investigation is made under this section, a record of 
the investigation shall be maintained by the formally designated unit 
identified in paragraph (a) of this section. The record of investigation 
shall include:
    (1) The name of the device;
    (2) The date the complaint was received;
    (3) Any device identification(s) and control number(s) used;
    (4) The name, address, and phone number of the complainant;
    (5) The nature and details of the complaint;
    (6) The dates and results of the investigation;
    (7) Any corrective action taken; and
    (8) Any reply to the complainant.
    (f) When the manufacturer's formally designated complaint unit is 
located at a site separate from the manufacturing

[[Page 150]]

establishment, the investigated complaint(s) and the record(s) of 
investigation shall be reasonably accessible to the manufacturing 
establishment.
    (g) If a manufacturer's formally designated complaint unit is 
located outside of the United States, records required by this section 
shall be reasonably accessible in the United States at either:
    (1) A location in the United States where the manufacturer's records 
are regularly kept; or
    (2) The location of the initial distributor.



                          Subpart N--Servicing



Sec. 820.200  Servicing.

    (a) Where servicing is a specified requirement, each manufacturer 
shall establish and maintain instructions and procedures for performing 
and verifying that the servicing meets the specified requirements.
    (b) Each manufacturer shall analyze service reports with appropriate 
statistical methodology in accordance with Sec. 820.100.
    (c) Each manufacturer who receives a service report that represents 
an event which must be reported to FDA under part 803 or 804 of this 
chapter shall automatically consider the report a complaint and shall 
process it in accordance with the requirements of Sec. 820.198.
    (d) Service reports shall be documented and shall include:
    (1) The name of the device serviced;
    (2) Any device identification(s) and control number(s) used;
    (3) The date of service;
    (4) The individual(s) servicing the device;
    (5) The service performed; and
    (6) The test and inspection data.



                    Subpart O--Statistical Techniques



Sec. 820.250  Statistical techniques.

    (a) Where appropriate, each manufacturer shall establish and 
maintain procedures for identifying valid statistical techniques 
required for establishing, controlling, and verifying the acceptability 
of process capability and product characteristics.
    (b) Sampling plans, when used, shall be written and based on a valid 
statistical rationale. Each manufacturer shall establish and maintain 
procedures to ensure that sampling methods are adequate for their 
intended use and to ensure that when changes occur the sampling plans 
are reviewed. These activities shall be documented.



PART 821--MEDICAL DEVICE TRACKING REQUIREMENTS--Table of Contents




                      Subpart A--General Provisions

Sec.
821.1  Scope.
821.2  Exemptions and variances.
821.3  Definitions.
821.4  Imported devices.

                    Subpart B--Tracking Requirements

821.20  Devices subject to tracking.
821.25  Device tracking system and content requirements: manufacturer 
          requirements.

         Subpart C--Additional Requirements and Responsibilities

821.30  Tracking obligations of persons other than device manufacturers: 
          distributor requirements.

                   Subpart D--Records and Inspections

821.50  Availability.
821.55  Confidentiality.
821.60  Retention of records.

    Authority: 21 U.S.C. 331, 351, 352, 360, 360e, 360h, 360i, 371, 374.

    Source: 58 FR 43447, Aug. 16, 1993, unless otherwise noted.



                      Subpart A--General Provisions



Sec. 821.1  Scope.

    (a) The regulations in this part implement section 519(e) of the 
Federal Food, Drug, and Cosmetic Act (the act) which requires the 
adoption of a method of device tracking by any person who registers 
under section 510 of the act and is engaged in the manufacture and 
distribution of devices the failure of which would be reasonably likely 
to have serious adverse health consequences if the devices are life-
sustaining or life-supporting devices used outside of a device user 
facility or are permanently implantable devices. This

[[Page 151]]

part also applies to any other device that the Food and Drug 
Administration (FDA) designates as requiring a method of tracking to 
protect the public health. A device subject to this part either by 
statutory requirement or by FDA designation is referred to herein as a 
``tracked device.''
    (b) These regulations are intended to ensure that tracked devices 
can be traced from the device manufacturing facility to the person for 
whom the device is indicated, that is, the patient. Effective tracking 
of devices from the manufacturing facility, through the distributor 
network (including distributors, retailers, rental firms and other 
commercial enterprises, device user facilities and licensed 
practitioners) and, ultimately, to any person for whom the device is 
intended is necessary for the effectiveness of remedies prescribed by 
the act, such as patient notification (section 518(a) of the act) or 
device recall (section 518(e) of the act). Although these regulations do 
not preclude a manufacturer from involving outside organizations in that 
manufacturer's device tracking effort, the legal responsibility for 
complying with this part rests with manufacturers who must register 
under section 510 of the act, and that responsibility cannot be altered, 
modified, or in any way abrogated by contracts or other agreements.
    (c) Each manufacturer of a tracked device shall implement a method 
of tracking devices by August 29, 1993.
    (d) The primary burden for ensuring that the tracking system works 
rests upon the manufacturer. A manufacturer or any other person, 
including a distributor, final distributor, or multiple distributor, who 
distributes a device subject to tracking, who fails to comply with any 
applicable requirement of section 519(e) of the act or of this part, or 
any person who causes such failure, misbrands the device within the 
meaning of section 501(t)(2) of the act and commits a prohibited act 
within the meaning of sections 301(e) and 301(q)(1)(B) of the act.
    (e) Any person subject to this part who permanently discontinues 
doing business is required to notify FDA at the time the person notifies 
any government agency, court, or supplier, and provide FDA with a 
complete set of its tracking records and information. However, if a 
person ceases distribution of a tracked device but continues to do other 
business, that person continues to be responsible for compliance with 
this part unless another person, affirmatively and in writing, assumes 
responsibility for continuing the tracking of devices previously 
distributed under this part. Further, if a person subject to this part 
goes out of business completely, but other persons acquire the right to 
manufacture or distribute tracked devices, those other persons are 
deemed to be responsible for continuing the tracking responsibility of 
the previous person under this part.



Sec. 821.2  Exemptions and variances.

    (a) A manufacturer, importer, or distributor may seek an exemption 
or variance from one or more requirements of this part.
    (b) A request for an exemption or variance shall be submitted in the 
form of a petition under Sec. 10.30 of this chapter and shall comply 
with the requirements set out therein, except that a response shall be 
issued in 90 days. The Director or Deputy Directors, CDRH, or the 
Director, Office of Compliance, CDRH, shall issue responses to requests 
under this section. The petition shall also contain the following:
    (1) The name of the device and device class and representative 
labeling showing the intended use(s) of the device;
    (2) The reasons that compliance with the tracking requirements of 
this part is unnecessary;
    (3) A complete description of alternative steps that are available, 
or that the petitioner has already taken, to ensure that an effective 
tracking system is in place; and
    (4) Other information justifying the exemption or variance.
    (c) An exemption or variance is not effective until the Director, 
Office of Compliance and Surveillance, CDRH, approves the request under 
Sec. 10.30(e)(2)(i) of this chapter.
    (d) For petitions received under this section before August 29, 
1993, FDA will, within 60 days, approve or disapprove the petition or 
extend the effective date of this part for the device

[[Page 152]]

that is the subject of the petition. Any extension that FDA grants to 
the effective date will be based upon the additional time FDA needs to 
complete its review of the petition.

[58 FR 43447, Aug. 16, 1993, as amended at 59 FR 31138, June 17, 1994]



Sec. 821.3  Definitions.

    The following definitions and terms apply to this part:
    (a) Act means the Federal Food, Drug, and Cosmetic Act, 21 U.S.C. 
321 et seq., as amended.
    (b) Importer means the initial distributor of an imported device who 
is required to register under section 510 of the act and Sec. 807.20 of 
this chapter. ``Importer'' does not include anyone who only performs a 
service for the person who furthers the marketing, i.e., brokers, 
jobbers, or warehousers.
    (c) Manufacturer means any person, including any importer, repacker 
and/or relabeler, who manufactures, prepares, propagates, compounds, 
assembles, or processes a device or engages in any of the activities 
described in Sec. 807.3(d) of this chapter.
    (d) Device failure means the failure of a device to perform or 
function as intended, including any deviations from the device's 
performance specifications or intended use.
    (e) Serious adverse health consequences means any significant 
adverse experience related to a device, including device-related events 
which are life-threatening or which involve permanent or long-term 
injuries or illnesses.
    (f) Permanently implantable device means a device that is intended 
to be placed into a surgically or naturally formed cavity of the human 
body to continuously assist, restore, or replace the function of an 
organ system or structure of the human body throughout the useful life 
of the device. The term does not include any device which is intended 
and used for temporary purposes or which is intended for explantation.
    (g) Life-supporting or life-sustaining device used outside a device 
user facility means a device which is essential, or yields information 
that is essential, to the restoration or continuation of a bodily 
function important to the continuation of human life that is intended 
for use outside a hospital, nursing home, ambulatory surgical facility, 
or diagnostic or outpatient treatment facility. Physicians' offices are 
not device user facilities and, therefore, devices used therein are 
subject to tracking if they otherwise satisfy the statutory and 
regulatory criteria.
    (h) Distributor means any person who furthers the distribution of a 
device from the original place of manufacture to the person who makes 
delivery or sale to the ultimate user, i.e., the final or multiple 
distributor, but who does not repackage or otherwise change the 
container, wrapper, or labeling of the device or device package.
    (i) Final distributor means any person who distributes a tracked 
device intended for use by a single patient over the useful life of the 
device to the patient. This term includes, but is not limited to, 
licensed practitioners, retail pharmacies, hospitals, and other types of 
device user facilities.
    (j) Distributes means any distribution of a tracked device, 
including the charitable distribution of a tracked device. This term 
does not include the distribution of a device under an effective 
investigational device exemption in accordance with section 520(g) of 
the act and part 812 of this chapter or the distribution of a device for 
teaching, law enforcement, research, or analysis as specified in 
Sec. 801.125 of this chapter.
    (k) Multiple distributor means any device user facility, rental 
company, or any other entity that distributes a life-sustaining or life-
supporting device intended for use by more than one patient over the 
useful life of the device.
    (l) Licensed practitioner means a physician, dentist, or other 
health care practitioner licensed by the law of the State in which he or 
she practices to use or order the use of the tracked device.
    (m) Any term defined in section 201 of the act shall have the same 
definition in this part.



Sec. 821.4  Imported devices.

    For purposes of this part, the importer of a tracked device shall be 
considered the manufacturer and shall be

[[Page 153]]

required to comply with all requirements of this part applicable to 
manufacturers. Importers must keep all information required under this 
part in the United States.



                    Subpart B--Tracking Requirements



Sec. 821.20  Devices subject to tracking.

    (a) A manufacturer of any device the failure of which would be 
reasonably likely to have a serious adverse health consequence, that is 
either a life-sustaining or life-supporting device used outside of a 
device user facility or a permanently implantable device, or a 
manufacturer of any other device that FDA, in its discretion, designates 
for tracking, shall track that device in accordance with this part.
    (b) Manufacturers have the responsibility to identify devices that 
meet the criteria for tracking and to initiate tracking. By way of 
illustration and to provide guidance, FDA has set out below a list of 
example devices it regards as subject to tracking under the criteria set 
forth in this regulation.
    (1) Permanently implantable devices.

------------------------------------------------------------------------
  21 CFR                           Classification
------------------------------------------------------------------------
 870.3450  Vascular graft prosthesis of less than 6 millimeters diameter
 870.3460  Vascular graft prosthesis of 6 millimeters and greater
            diameter
(no cite)  Total temporomandibular joint prosthesis.
(no cite)  Glenoid fossa prosthesis.
(no cite)  Mandibular condyle prosthesis.
(no cite)  Interarticular disc prosthesis (interpositional implant).
 870.3545  Ventricular bypass (assist) device
 870.3610  Implantable pacemaker pulse generator
 870.3680  Cardiovascular permanent pacemaker electrode
 870.3800  Annuloplasty ring
 870.3925  Replacement heart valve
(no cite)  Automatic implantable cardioverter/defibrillator
 878.3720  Tracheal prosthesis
 882.5820  Implanted cerebellar stimulator
 882.5830  Implanted diaphragmatic/phrenic nerve stimulator
(no cite)  Implantable infusion pumps
------------------------------------------------------------------------

    (2) Life-sustaining or life-supporting devices used outside device 
user facilities

------------------------------------------------------------------------
  21 CFR                           Classification
------------------------------------------------------------------------
 868.2375  Breathing frequency monitors (apnea monitors) (including
            ventilatory efforts monitors)
 868.5895  Continuous ventilator
 870.5300  DC-defibrillator and paddles
------------------------------------------------------------------------

    (c) FDA designates the following devices as subject to tracking. 
Manufacturers must track these devices in accordance with this part.

------------------------------------------------------------------------
  21 CFR                           Classification
------------------------------------------------------------------------
 876.3350  Penile inflatable implant
 878.3530  Silicone inflatable breast prosthesis
 878.3540  Silicone gel-filled breast prosthesis
 876.3750  Testicular prosthesis, silicone gel-filled
(no cite)  Silicone gel-filled chin prosthesis
(no cite)  Silicone gel-filled angel chik reflux valve
 880.5725  Infusion pumps
------------------------------------------------------------------------

    (d) FDA, when responding to premarket notification submissions and 
approving premarket approval applications, will notify the sponsor that 
FDA believes the device meets the criteria of section 519(e)(1) and 
therefore should be tracked. FDA will also, after notifying the sponsor, 
publish a notice in the Federal Register announcing that FDA believes a 
new generic type of device is subject to tracking and soliciting comment 
on FDA's position. If the device is a new generic type of device not 
already on the example list above, FDA will add it to this list.

[58 FR 43447, Aug. 16, 1993, as amended at 58 FR 43455, Aug. 16, 1993; 
59 FR 15052, Mar. 31, 1994.]



Sec. 821.25  Device tracking system and content requirements: manufacturer requirements.

    (a) A manufacturer of a tracked device shall adopt a method of 
tracking for each such type of device that it distributes that enables a 
manufacturer to provide FDA with the following information in writing 
for each tracked device distributed:
    (1) Except as required by order under section 518(e) of the act, 
within 3 working days of a request from FDA, prior to the distribution 
of a tracked device to a patient, the name, address, and telephone 
number of the distributor, multiple distributor, or final distributor 
holding the device for distribution and the location of the device;
    (2) Within 10 working days of a request from FDA for life-sustaining 
or life-supporting devices used outside a device user facility that are 
intended for use by a single patient over the life of the device and 
permanent implants that are tracked devices, after distribution to or 
implantation in a patient:
    (i) The lot number, batch number, model number, or serial number of 
the

[[Page 154]]

device or other identifier necessary to provide for effective tracking 
of the devices;
    (ii) The date the device was shipped by the manufacturer;
    (iii) The name, address, telephone number, and social security 
number (if available) of the patient receiving the device;
    (iv) The date the device was provided to the patient;
    (v) The name, mailing address, and telephone number of the 
prescribing physician;
    (vi) The name, mailing address, and telephone number of the 
physician regularly following the patient if different than the 
prescribing physician; and
    (vii) If applicable, the date the device was explanted and the name, 
mailing address, and telephone number of the explanting physician; the 
date of the patient's death; or the date the device was returned to the 
manufacturer, permanently retired from use, or otherwise permanently 
disposed of.
    (3) Except as required by order under section 518(e) within 10 
working days of a request from FDA for life-sustaining or life-
supporting devices used outside device user facilities that are intended 
for use by more than one patient and that are tracked devices, after the 
distribution of the device to the multiple distributor:
    (i) The lot model number, batch number, serial number of the device 
or other identifier necessary to provide for effective tracking of the 
device;
    (ii) The date the device was shipped by the manufacturer;
    (iii) The name, address, and telephone number of the multiple 
distributor;
    (iv) The name, address, telephone number, and social security number 
(if available) of the patient using the device;
    (v) The location of the device;
    (vi) The date the device was provided for use by the patient;
    (vii) The name, address, and telephone number of the prescribing 
physician; and
    (viii) If and when applicable, the date the device was returned to 
the manufacturer, permanently retired from use, or otherwise permanently 
disposed of.
    (b) A manufacturer of a tracked device shall keep current records in 
accordance with its standard operating procedure of the information 
identified in paragraphs (a)(1), (a)(2) and (a)(3)(i) through 
(a)(3)(iii) of this section on each tracked device released for 
distribution for as long as such device is in use or in distribution for 
use.
    (c) A manufacturer of a tracked device shall establish a written 
standard operating procedure for the collection, maintenance, and 
auditing of the data specified in paragraphs (a) and (b) of this 
section. A manufacturer shall make this standard operating procedure 
available to FDA upon request. A manufacturer shall incorporate the 
following into the standard operating procedure:
    (1) Data collection and recording procedures, which shall include a 
procedure for recording when data which is required under this part is 
missing and could not be collected and the reason why such required data 
is missing and could not be collected;
    (2) A method for recording all modifications or changes to the 
tracking system or to the data collected and maintained under the 
tracking system, reasons for any modification or change, and dates of 
any modification or change. Modification and changes included under this 
requirement include modifications to the data (including termination of 
tracking), the data format, the recording system, and the file 
maintenance procedures system; and
    (3) A quality assurance program that includes an audit procedure to 
be run for each device product subject to tracking, at not less than 6-
month intervals for the first 3 years of distribution and at least once 
a year thereafter. This audit procedure shall provide for statistically 
relevant sampling of the data collected to ensure the accuracy of data 
and performance testing of the functioning of the tracking system.
    (d) When a manufacturer becomes aware that a distributor, final 
distributor, or multiple distributor has not collected, maintained, or 
furnished any record or information required by this part, the 
manufacturer shall notify the FDA district office responsible for the 
area in which the distributor,

[[Page 155]]

final distributor, or multiple distributor is located of the failure of 
such persons to comply with the requirements of this part. Manufacturers 
shall have taken reasonable steps to obtain compliance by the 
distributor, multiple distributor, or final distributor in question 
before notifying FDA.
    (e) A manufacturer may petition for an exemption or variance from 
one or more requirements of this part according to the procedures in 
Sec. 821.2 of this chapter.



         Subpart C--Additional Requirements and Responsibilities



Sec. 821.30  Tracking obligations of persons other than device manufacturers: distributor requirements.

    (a) A distributor, final distributor, or multiple distributor of any 
tracked device shall, upon purchasing or otherwise acquiring any 
interest in such a device, promptly provide the manufacturer tracking 
the device with the following information:
    (1) The name and address of the distributor, final distributor or 
multiple distributor;
    (2) The lot number, batch number, model number, or serial number of 
the device or other identifier used by the manufacturer to track the 
device;
    (3) The date the device was received;
    (4) The person from whom the device was received;
    (5) If and when applicable, the date the device was explanted, the 
date of the patient's death, or the date the device was returned to the 
distributor, permanently retired from use, or otherwise permanently 
disposed of.
    (b) A final distributor, upon sale or other distribution of a 
tracked device for use in or by the patient, shall promptly provide the 
manufacturer tracking the device with the following information:
    (1) The name and address of the final distributor,
    (2) The lot number, batch number, model number, or serial number of 
the device or other identifier used by the manufacturer to track the 
device;
    (3) The name, address, telephone number, and social security number 
(if available) of the patient receiving the device;
    (4) The date the device was provided to the patient or for use in 
the patient;
    (5) The name, mailing address, and telephone number of the 
prescribing physician;
    (6) The name, mailing address, and telephone number of the physician 
regularly following the patient if different than the prescribing 
physician; and
    (7) When applicable, the date the device was explanted and the name, 
mailing address, and telephone number of the explanting physician, the 
date of the patient's death, or the date the device was returned to the 
manufacturer, permanently retired from use, or otherwise permanently 
disposed of.
    (c)(1) A multiple distributor shall keep written records of the 
following each time such device is distributed for use by a patient:
    (i) The lot number, batch number, or model number, or serial number 
of the device or other identifier used by the manufacturer to track the 
device;
    (ii) The name, address, telephone number, and social security number 
(if available) of the patient using the device;
    (iii) The location of the device;
    (iv) The date the device was provided for use by the patient;
    (v) The name, address, and telephone number of the prescribing 
physician;
    (vi) The name, address, and telephone number of the physician 
regularly following the patient if different than the prescribing 
physician; and
    (vii) When applicable, the date the device was permanently retired 
from use or otherwise permanently disposed of.
    (2) Except as required by order under section 518(e) of the act, any 
person who is a multiple distributor subject to the recordkeeping 
requirement of paragraph (c)(1) of this section shall, within 5 working 
days of a request from the manufacturer or within 10 working days of a 
request from FDA for the information identified in paragraph (c)(1) of 
this section, provide such information to the manufacturer or FDA.
    (d) A distributor, final distributor, or multiple distributor shall 
make any records required to be kept under this part available to the 
manufacturer of

[[Page 156]]

the tracked device for audit upon written request by an authorized 
representative of the manufacturer.
    (e) A distributor, final distributor, or multiple distributor may 
petition for an exemption or variance from one or more requirements of 
this part according to the procedures in Sec. 821.2.



                   Subpart D--Records and Inspections



Sec. 821.50  Availability.

    (a) Manufacturers, distributors, multiple distributors, and final 
distributors shall, upon the presentation by an FDA representative of 
official credentials and the issuance of Form FD 482 at the initiation 
of an inspection of an establishment or person under section 704 of the 
act, make each record and all information required to be collected and 
maintained under this part and all records and information related to 
the events and persons identified in such records available to FDA 
personnel.
    (b) Records and information referenced in paragraph (a) of this 
section shall be available to FDA personnel for purposes of reviewing, 
copying, or any other use related to the enforcement of the act and this 
part. Records required to be kept by this part shall be kept in a 
centralized point for each manufacturer or distributor within the United 
States.



Sec. 821.55  Confidentiality.

    (a) Records and other information submitted to FDA under this part 
shall be protected from public disclosure to the extent permitted under 
part 20 of this chapter, and in accordance with Sec. 20.63 of this 
chapter, information contained in such records that would identify 
patient or research subjects shall not be available for public 
disclosure except as provided in those parts.
    (b) Patient names or other identifiers may be disclosed to a 
manufacturer or other person subject to this part or to a physician when 
the health or safety of the patient requires that such persons have 
access to the information. Such notification will be pursuant to 
agreement that the record or information will not be further disclosed 
except as the health aspects of the patient requires. Such notification 
does not constitute public disclosure and will not trigger the 
availability of the same information to the public generally.



Sec. 821.60  Retention of records.

    Persons required to maintain records under this part shall maintain 
such records for the useful life of each tracked device they manufacture 
or distribute. The useful life of a device is the time a device is in 
use or in distribution for use. For example, a record may be retired if 
the person maintaining the record becomes aware of the fact that the 
device is no longer in use, has been explanted, returned to the 
manufacturer, or the patient has died.



PART 860--MEDICAL DEVICE CLASSIFICATION PROCEDURES--Table of Contents




                           Subpart A--General

Sec.
860.1  Scope.
860.3  Definitions.
860.5  Confidentiality and use of data and information submitted in 
          connection with classification and reclassification.
860.7  Determination of safety and effectiveness.

                        Subpart B--Classification

860.84  Classification procedures for ``old devices.''
860.93  Classification of implants, life-supporting or life-sustaining 
          devices.
860.95  Exemptions from sections 510, 519, and 520(f) of the act.

                       Subpart C--Reclassification

860.120  General.
860.123  Reclassification petition: Content and form.
860.125  Consultation with panels.
860.130  General procedures under section 513(e) of the act.
860.132  Procedures when the Commissioner initiates a performance 
          standard or premarket approval proceeding under section 514(b) 
          or 515(b) of the act.
860.134  Procedures for ``new devices'' under section 513(f) of the act 
          and reclassification of certain devices.
860.136  Procedures for transitional products under section 520(l) of 
          the act.

    Authority: 21 U.S.C. 360c, 360d, 360e, 360i, 360j, 371, 374.

    Source: 43 FR 32993, July 28, 1978, unless otherwise noted.

[[Page 157]]



                           Subpart A--General



Sec. 860.1  Scope.

    (a) This part implements sections 513, 514(b), 515(b), and 520(l) of 
the act with respect to the classification and reclassification of 
devices intended for human use.
    (b) This part prescribes the criteria and procedures to be used by 
classification panels in making their recommendations and by the 
Commissioner in making the Commissioner's determinations regarding the 
class of regulatory control (class I, class II, or class III) 
appropriate for particular devices. Supplementing the general Food and 
Drug Administration procedures governing advisory committees (part 14 of 
this chapter), this part also provides procedures for manufacturers, 
importers, and other interested persons to participate in proceedings to 
classify and reclassify devices. This part also describes the kind of 
data required for determination of the safety and effectiveness of a 
device, and the circumstances under which information submitted to 
classification panels or to the Commissioner in connection with 
classification and reclassification proceedings will be available to the 
public.



Sec. 860.3  Definitions.

    For the purposes of this part:
    (a) Act means the Federal Food, Drug, and Cosmetic Act.
    (b) Commissioner means the Commissioner of Food and Drugs, Food and 
Drug Administration, United States Department of Health and Human 
Services, or the Commissioner's designee.
    (c) Class means one of the three categories of regulatory control 
for medical devices, defined below:
    (1) Class I means the class of devices that are subject to only the 
general controls authorized by or under sections 501 (adulteration), 502 
(misbranding), 510 (registration), 516 (banned devices), 518 
(notification and other remedies), 519 (records and reports), and 520 
(general provisions) of the act. A device is in class I if (i) general 
controls are sufficient to provide reasonable assurance of the safety 
and effectiveness of the device, or (ii) there is insufficient 
information from which to determine that general controls are sufficient 
to provide reasonable assurance of the safety and effectiveness of the 
device or to establish special controls to provide such assurance, but 
the device is not life-supporting or life-sustaining or for a use which 
is of substanial importance in preventing impairment of human health, 
and which does not present a potential unreasonable risk of illness of 
injury.
    (2) Class II means the class of devices that is or eventually will 
be subject to special controls. A device is in class II if general 
controls alone are insufficient to provide reasonable assurance of its 
safety and effectiveness and there is sufficient information to 
establish special controls, including the promulgation of performance 
standards, postmarket surveillance, patient registries, development and 
dissemination of guidelines (including guidelines for the submission of 
clinical data in premarket notification submissions in accordance with 
section 510(k) of the act), recommendations, and other appropriate 
actions as the Commissioner deems necessary to provide such assurance. 
For a device that is purported or represented to be for use in 
supporting or sustaining human life, the Commissioner shall examine and 
identify the special controls, if any, that are necessary to provide 
adequate assurance of safety and effectiveness and describe how such 
controls provide such assurance.
    (3) Class III means the class of devices for which premarket 
approval is or will be required in accordance with section 515 of the 
act. A device is in class III if insufficient information exists to 
determine that general controls are sufficient to provide reasonable 
assurance of its safety and effectiveness or that application of special 
controls described in paragraph (c)(2) of this section would provide 
such assurance and if, in addition, the device is life-supporting or 
life-sustaining, or for a use which is of substantial importance in 
preventing impairment of human health, or if the device presents a 
potential unreasonable risk of illness or injury.
    (d) Implant means a device that is placed into a surgically or 
naturally

[[Page 158]]

formed cavity of the human body. A device is regarded as an implant for 
the purpose of this part only if it is intended to remain implanted 
continuously for a period of 30 days or more, unless the Commissioner 
determines otherwise in order to protect human health.
    (e) Life-supporting or life-sustaining device means a device that is 
essential to, or that yields information that is essential to, the 
restoration or continuation of a bodily function important to the 
continuation of human life.
    (f) Classification questionnaire means a specific series of 
questions prepared by the Commissioner for use as guidelines by 
classification panels preparing recommendations to the Commissioner 
regarding classification and by petitioners submitting petitions for 
reclassification. The questions relate to the safety and effectiveness 
characteristics of a device and the answers are designed to help the 
Commissioner determine the proper classification of the device.
    (g) Supplemental data sheet means information compiled by a 
classification panel or submitted in a petition for reclassification, 
including:
    (1) A summary of the reasons for the recommendation (or petition);
    (2) A summary of the data upon which the recommendation (or 
petition) is based;
    (3) An identification of the risks to health (if any) presented by 
the device;
    (4) To the extent practicable in the case of a class II or class III 
device, a recommendation for the assignment of a priority for the 
application of the requirements of performance standards or premarket 
approval;
    (5) In the case of a class I device, a recommendation whether the 
device should be exempted from any of the requirements of registration, 
record-keeping and reporting, or good manufacturing practice 
regulations;
    (6) In the case of an implant or a life-supporting or life-
sustaining device for which classification in class III is not 
recommended, a statement of the reasons for not recommending that the 
device be classified in class III;
    (7) Identification of any needed restrictions on the use of the 
device, e.g., whether the device requires special labeling, should be 
banned, or should be used only upon authorization of a practitioner 
licensed by law to administer or use such device; and
    (8) Any known existing standards applicable to the device, device 
components, or device materials.
    (h) Classification panel means one of the several advisory 
committees established by the Commissioner under section 513 of the act 
and part 14 of this chapter for the purpose of making recommendations to 
the Commissioner on the classification and reclassification of devices 
and for other purposes prescribed by the act or by the Commissioner.
    (i) Generic type of device means a grouping of devices that do not 
differ significantly in purpose, design, materials, energy source, 
function, or any other feature related to safety and effectiveness, and 
for which similar regulatory controls are sufficient to provide 
reasonable assurance of safety and effectiveness.
    (j) Petition means a submission seeking reclassification of a device 
in accordance with Sec. 860.123.

[43 FR 32993, July 28, 1978, as amended at 57 FR 58403, Dec. 10, 1992]



Sec. 860.5  Confidentiality and use of data and information submitted in connection with classification and reclassification.

    (a) This section governs the availability for public disclosure and 
the use by the Commissioner of data and information submitted to 
classification panels or to the Commissioner in connection with the 
classification or reclassification of devices under this part.
    (b) In general, data and information submitted to classification 
panels in connection with the classification of devices under 
Sec. 860.84 will be available immediately for public disclosure upon 
request. However, except as provided by the special rules in paragraph 
(c) of this section, this provision does not apply to data and 
information exempt from public disclosure in accordance with part 20 of 
this chapter: Such data and information will be available only in 
accordance with part 20.
    (c)(1) Safety and effectiveness data submitted to classification 
panels or to

[[Page 159]]

the Commissioner in connection with the classification of a device under 
Sec. 860.84, which have not been disclosed previously to the public, as 
described in Sec. 20.81 of this chapter, shall be regarded as 
confidential if the device is classified in to class III. Because the 
classification of a device under Sec. 860.84 may be ascertained only 
upon publication of a final regulation, all safety and effectiveness 
data that have not been disclosed previously are not available for 
public disclosure unless and until the device is classified into class I 
or II, in which case the procedure in paragraph (c)(2) of this section 
applies.
    (2) Thirty days after publication of a final regulation under 
Sec. 860.84 classifying a device into class I or class II, safety and 
effectiveness data submitted for that device that had been regarded as 
confidential under paragraph (c)(1) of this section will be available 
for public disclosure and placed on public display in the office of the 
Dockets Management Branch, Food and Drug Administration unless, within 
that 30-day period, the person who submitted the data demonstrates that 
the data still fall within the exemption for trade secrets and 
confidential commercial information described in Sec. 20.61 of this 
chapter. Safety and effectiveness data submitted for a device that is 
classified into class III by regulation in accordance with Sec. 860.84 
will remain confidential and unavailable for public disclosure so long 
as such data have not been disclosed to the public as described in 
Sec. 20.81 of this chapter.
    (3) Because device classification affects generic types of devices, 
in making determinations under Sec. 860.84 concerning the initial 
classification of a device, the classification panels and the 
Commissioner may consider safety and effectiveness data developed for 
another device in the same generic type, regardless of whether such data 
are regarded currently as confidential under paragraph (c)(1) of this 
section.
    (d)(1) The fact of its existence and the contents of a petition for 
reclassification filed in accordance with Sec. 860.130 or Sec. 860.132 
are available for public disclosure at the time the petition is received 
by the Food and Drug Administration.
    (2) The fact of the existence of a petition for reclassification 
filed in accordance with Sec. 860.134 or Sec. 860.136 is available for 
public disclosure at the time the petition is received by the Food and 
Drug Administration. The contents of such a petition are not available 
for public disclosure for the period of time following its receipt (not 
longer than 30 days) during which the petition is reviewed for any 
deficiencies preventing the Commissioner from making a decision on it. 
Once it is determined that the petition contains no deficiencies 
preventing the Commissioner from making a decision on it, the petition 
will be filed with the Dockets Management Branch and its entire contents 
will be available for public disclosure and subject to consideration by 
classification panels and by the Commissioner in making a decision on 
the petition. If, during this 30-day period of time, the petition is 
found to contain deficiencies that prevent the Commissioner from making 
a decision on it, the petitioner will be so notified and afforded an 
opportunity to correct the deficiencies.

Thirty days after notice to the petitioner of deficiencies in the 
petition, the contents of the petition will be available for public 
disclosure unless, within that 30 days, the petitioner submits 
supplemental material intended to correct the deficiencies in the 
petition. The Commissioner, in the Commissioner's discretion, may allow 
withdrawal of a deficient petition during the 30-day period provided for 
correcting deficiencies. Any supplemental material submitted by the 
petitioner, together with the material in the original petition, is 
considered as a new petition. The new petition is reviewed for 
deficiencies in the same manner as the original petition, and the same 
procedures for notification and correction of deficiencies are followed. 
Once the petitioner has corrected the deficiencies, the entire contents 
of the petition will be available for public disclosure and subject to 
consideration by classification panels and by the Commissioner in making 
a decision on the petition. Deficient petitions which have not been 
corrected within 180 days after notification of deficiency will be 
returned to

[[Page 160]]

the petitioner and will not be considered further unless resubmitted.
    (e) The Commissioner may not disclose, or use as the basis for 
reclassification of a device from class III to class II, any information 
reported to or otherwise obtained by the Commissioner under section 513, 
514, 515, 516, 518, 519, 520(f), 520(g), or 704 of the act that falls 
within the exemption described in Sec. 20.61 of this chapter for trade 
secrets and confidential commercial information. The exemption described 
in Sec. 20.61 does not apply to data or information contained in a 
petition for reclassification submitted in accordance with Sec. 860.130 
or Sec. 860.132, or in a petition submitted in accordance with 
Sec. 860.134 or Sec. 860.136 that has been determined to contain no 
deficiencies that prevent the Commissioner from making a decision on it. 
Accordingly, all data and information contained in such petitions may be 
disclosed by the Commissioner and used as the basis for reclassification 
of a device from class III to class II.
    (f) For purposes of this section, safety and effectiveness data 
include data and results derived from all studies and tests of a device 
on animals and humans and from all studies and tests of the device 
itself intended to establish or determine its safety and effectiveness.



Sec. 860.7  Determination of safety and effectiveness.

    (a) The classification panels, in reviewing evidence concerning the 
safety and effectiveness of a device and in preparing advice to the 
Commissioner, and the Commissioner, in making determinations concerning 
the safety and effectiveness of a device, will apply the rules in this 
section.
    (b) In determining the safety and effectiveness of a device for 
purposes of classification, establishment of performance standards for 
class II devices, and premarket approval of class III devices, the 
Commissioner and the classification panels will consider the following, 
among other relevant factors:
    (1) The persons for whose use the device is represented or intended;
    (2) The conditions of use for the device, including conditions of 
use prescribed, recommended, or suggested in the labeling or advertising 
of the device, and other intended conditions of use;
    (3) The probable benefit to health from the use of the device 
weighed against any probable injury or illness from such use; and
    (4) The reliability of the device.
    (c)(1) Although the manufacturer may submit any form of evidence to 
the Food and Drug Administration in an attempt to substantiate the 
safety and effectiveness of a device, the agency relies upon only valid 
scientific evidence to determine whether there is reasonable assurance 
that the device is safe and effective. After considering the nature of 
the device and the rules in this section, the Commissioner will 
determine whether the evidence submitted or otherwise available to the 
Commissioner is valid scientific evidence for the purpose of determining 
the safety or effectiveness of a particular device and whether the 
available evidence, when taken as a whole, is adequate to support a 
determination that there is reasonable assurance that the device is safe 
and effective for its conditions of use.
    (2) Valid scientific evidence is evidence from well-controlled 
investigations, partially controlled studies, studies and objective 
trials without matched controls, well-documented case histories 
conducted by qualified experts, and reports of significant human 
experience with a marketed device, from which it can fairly and 
responsibly be concluded by qualified experts that there is reasonable 
assurance of the safety and effectiveness of a device under its 
conditions of use. The evidence required may vary according to the 
characteristics of the device, its conditions of use, the existence and 
adequacy of warnings and other restrictions, and the extent of 
experience with its use. Isolated case reports, random experience, 
reports lacking sufficient details to permit scientific evaluation, and 
unsubstantiated opinions are not regarded as valid scientific evidence 
to show safety or effectiveness. Such information may be considered, 
however, in identifying a device the safety and effectiveness of which 
is questionable.

[[Page 161]]

    (d)(1) There is reasonable assurance that a device is safe when it 
can be determined, based upon valid scientific evidence, that the 
probable benefits to health from use of the device for its intended uses 
and conditions of use, when accompanied by adequate directions and 
warnings against unsafe use, outweigh any probable risks. The valid 
scientific evidence used to determine the safety of a device shall 
adequately demonstrate the absence of unreasonable risk of illness or 
injury associated with the use of the device for its intended uses and 
conditions of use.
    (2) Among the types of evidence that may be required, when 
appropriate, to determine that there is reasonable assurance that a 
device is safe are investigations using laboratory animals, 
investigations involving human subjects, and nonclinical investigations 
including in vitro studies.
    (e)(1) There is reasonable assurance that a device is effective when 
it can be determined, based upon valid scientific evidence, that in a 
significant portion of the target population, the use of the device for 
its intended uses and conditions of use, when accompanied by adequate 
directions for use and warnings against unsafe use, will provide 
clinically significant results.
    (2) The valid scientific evidence used to determine the 
effectiveness of a device shall consist principally of well-controlled 
investigations, as defined in paragraph (f) of this section, unless the 
Commissioner authorizes reliance upon other valid scientific evidence 
which the Commissioner has determined is sufficient evidence from which 
to determine the effectiveness of a device, even in the absence of well-
controlled investigations. The Commissioner may make such a 
determination where the requirement of well-controlled investigations in 
paragraph (f) of this section is not reasonably applicable to the 
device.
    (f) The following principles have been developed over a period of 
years and are recognized by the scientific community as the essentials 
of a well-controlled clinical investigation. They provide the basis for 
the Commissioner's determination whether there is reasonable assurance 
that a device is effective based upon well-controlled investigations and 
are also useful in assessing the weight to be given to other valid 
scientific evidence permitted under this section.
    (1) The plan or protocol for the study and the report of the results 
of a well-controlled investigation shall include the following:
    (i) A clear statement of the objectives of the study;
    (ii) A method of selection of the subjects that:
    (a) Provides adequate assurance that the subjects are suitable for 
the purposes of the study, provides diagnostic criteria of the condition 
to be treated or diagnosed, provides confirmatory laboratory tests where 
appropriate and, in the case of a device to prevent a disease or 
condition, provides evidence of susceptibility and exposure to the 
condition against which prophylaxis is desired;
    (b) Assigns the subjects to test groups, if used, in such a way as 
to minimize any possible bias;
    (c) Assures comparability between test groups and any control groups 
of pertinent variables such as sex, severity or duration of the disease, 
and use of therapy other than the test device;
    (iii) An explanation of the methods of observation and recording of 
results utilized, including the variables measured, quantitation, 
assessment of any subject's response, and steps taken to minimize any 
possible bias of subjects and observers;
    (iv) A comparison of the results of treatment or diagnosis with a 
control in such a fashion as to permit quantitative evaluation. The 
precise nature of the control must be specified and an explanation 
provided of the methods employed to minimize any possible bias of the 
observers and analysts of the data. Level and methods of ``blinding,'' 
if appropriate and used, are to be documented. Generally, four types of 
comparisons are recognized:
    (a) No treatments. Where objective measurements of effectiveness are 
available and placebo effect is negligible, comparison of the objective 
results in comparable groups of treated and untreated patients;
    (b) Placebo control. Where there may be a placebo effect with the 
use of a device, comparison of the results of use of

[[Page 162]]

the device with an ineffective device used under conditions designed to 
resemble the conditions of use under investigation as far as possible;
    (c) Active treatment control. Where an effective regimen of therapy 
may be used for comparison, e.g., the condition being treated is such 
that the use of a placebo or the withholding of treatment would be 
inappropriate or contrary to the interest of the patient;
    (d) Historical control. In certain circumstances, such as those 
involving diseases with high and predictable mortality or signs and 
symptoms of predictable duration or severity, or in the case of 
prophylaxis where morbidity is predictable, the results of use of the 
device may be compared quantitatively with prior experience historically 
derived from the adequately documented natural history of the disease or 
condition in comparable patients or populations who received no 
treatment or who followed an established effective regimen (therapeutic, 
diagnostic, prophylactic).
    (v) A summary of the methods of analysis and an evaluation of the 
data derived from the study, including any appropriate statistical 
methods utilized.
    (2) To insure the reliability of the results of an investigation, a 
well-controlled investigation shall involve the use of a test device 
that is standardized in its composition or design and performance.
    (g)(1) It is the responsibility of each manufacturer and importer of 
a device to assure that adequate, valid scientific evidence exists, and 
to furnish such evidence to the Food and Drug Administration to provide 
reasonable assurance that the device is safe and effective for its 
intended uses and conditions of use. The failure of a manufacturer or 
importer of a device to present to the Food and Drug Administration 
adequate, valid scientific evidence showing that there is reasonable 
assurance of the safety and effectiveness of the device, if regulated by 
general controls alone, or by general controls and performance 
standards, may support a determination that the device be classified 
into class III.
    (2) The Commissioner may require that a manufacturer, importer, or 
distributor make reports or provide other information bearing on the 
classification of a device and indicating whether there is reasonable 
assurance of the safety and effectiveness of the device or whether it is 
adulterated or misbranded under the act.
    (3) A requirement for a report or other information under this 
paragraph will comply with section 519 of the act. Accordingly, the 
requirement will state the reason or purpose for such request; will 
describe the required report or information as clearly as possible; will 
not be imposed on a manufacturer, importer, or distributor of a 
classified device that has been exempted from such a requirement in 
accordance with Sec. 860.95; will prescribe the time for compliance with 
the requirement; and will prescribe the form and manner in which the 
report or information is to be provided.
    (4) Required information that has been submitted previously to the 
Center for Devices and Radiological Health need not be resubmitted, but 
may be incorporated by reference.

[43 FR 32993, July 28, 1978, as amended at 53 FR 11253, Apr. 6, 1988]



                        Subpart B--Classification



Sec. 860.84  Classification procedures for ``old devices.''

    (a) This subpart sets forth the procedures for the original 
classification of a device that either was in commercial distribution 
before May 28, 1976, or is substantially equivalent to a device that was 
in commercial distribution before that date. Such a device will be 
classified by regulation into either class I (general controls), class 
II (special controls) or class III (premarket approval), depending upon 
the level of regulatory control required to provide reasonable assurance 
of the safety and effectiveness of the device (Sec. 860.3(c)). This 
subpart does not apply to a device that is classified into class III by 
statute under section 513(f) of the act because the Food and Drug 
Administration has determined that the device is not ``substantially 
equivalent'' to any device subject to this subpart or under section 
520(l) (1) through (3) of the act because the device was regarded 
previously as a new drug. In classifying a

[[Page 163]]

device under this section, the Food and Drug Administration will follow 
the procedures described in paragraphs (b) through (g) of this section.
    (b) The Commissioner refers the device to the appropriate 
classification panel organized and operated in accordance with section 
513 (b) and (c) of the act and part 14 of this chapter.
    (c) In order to make recommendations to the Commissioner on the 
class of regulatory control (class I, class II, or class III) 
appropriate for the device, the panel reviews the device for safety and 
effectiveness. In so doing, the panel:
    (1) Considers the factors set forth in Sec. 860.7 relating to the 
determination of safety and effectiveness;
    (2) Determines the safety and effectiveness of the device on the 
basis of the types of scientific evidence set forth in Sec. 860.7;
    (3) Answers the questions in the classification questionnaire 
applicable to the device being classified;
    (4) Completes a supplemental data sheet for the device;
    (5) Provides, to the maximum extent practicable, an opportunity for 
interested persons to submit data and views on the classification of the 
device in accordance with part 14 of this chapter.
    (d) Based upon its review of evidence of the safety and 
effectiveness of the device, and applying the definition of each class 
in Sec. 860.3(c), the panel submits to the Commissioner a recommendation 
regarding the classification of the device. The recommendation will 
include:
    (1) A summary of the reasons for the recommendation;
    (2) A summary of the data upon which the recommendation is based, 
accompanied by references to the sources containing such data;
    (3) An identification of the risks to health (if any) presented by 
the device;
    (4) In the case of a recommendation for classification into class I, 
a recommendation as to whether the device should be exempted from the 
requirements of one or more of the following sections of the act: 
section 510 (registration, product listing, and premarket notification) 
section 519 (records and reports) and section 520(f) (good manufacturing 
practice regulations) in accordance with Sec. 860.95;
    (5) In the case of a recommendation for classification into class II 
or class III, to the extent practicable, a recommendation for the 
assignment to the device of a priority for the application of a 
performance standard or a premarket approval requirement;
    (6) In the case of a recommendation for classification of an implant 
or a life-supporting or life-sustaining device into class I or class II, 
a statement of why premarket approval is not necessary to provide 
reasonable assurance of the safety and effectiveness of the device, 
accompanied by references to supporting documentation and data 
satisfying the requirements of Sec. 860.7, and an identification of the 
risks to health, if any, presented by the device.
    (e) A panel recommendation is regarded as preliminary until the 
Commissioner has reviewed it, discussed it with the panel if 
appropriate, and published a proposed regulation classifying the device. 
Preliminary panel recommendations are filed in the Dockets Management 
Branch's office upon receipt and are available to the public upon 
request.
    (f) The Commissioner publishes the panel's recommendation in the 
Federal Register, together with a proposed regulation classifying the 
device, and other devices of that generic type, and provides interested 
persons an opportunity to submit comments on the recommendation and 
proposed regulation.
    (g) The Commissioner reviews the comments and issues a final 
regulation classifying the device and other devices of that generic 
type. The regulation will:
    (1) If classifying the device into class I, prescribe which, if any, 
of the requirements of sections 510, 519, and 520(f) of the act will not 
apply to the device and state the reasons for making the requirements 
inapplicable, in accordance with Sec. 860.95;
    (2) If classifying the device into class II or class III, at the 
discretion of the Commissioner, establish priorities for the application 
to the device of a performance standard or a premarket approval 
requirement;

[[Page 164]]

    (3) If classifying an implant, or life-supporting or life-sustaining 
device, comply with Sec. 860.93(b).

[43 FR 32993, July 28, 1978, as amended at 57 FR 58404, Dec. 10, 1992; 
64 FR 404, Jan. 5, 1999]



Sec. 860.93  Classification of implants, life-supporting or life-sustaining devices.

    (a) The classification panel will recommend classification into 
class III of any implant or life-supporting or life-sustaining device 
unless the panel determines that such classification is not necessary to 
provide reasonable assurance of the safety and effectiveness of the 
device. If the panel recommends classification or reclassification of 
such a device into a class other than class III, it shall set forth in 
its recommendation the reasons for so doing together with references to 
supporting documentation and data satisfying the requirements of 
Sec. 860.7, and an identification of the risks to health, if any, 
presented by the device.
    (b) The Commissioner will classify an implant or life-supporting or 
life-sustaining device into class III unless the Commissioner determines 
that such classification is not necessary to provide reasonable 
assurance of the safety and effectiveness of the device. If the 
Commissioner proposes to classify or reclassify such a device into a 
class other than class III, the regulation or order effecting such 
classification or reclassification will be accompanied by a full 
statement of the reasons for so doing. A statement of the reasons for 
not classifying or retaining the device in class III may be in the form 
of concurrence with the reasons for the recommendation of the 
classification panel, together with supporting documentation and data 
satisfying the requirements of Sec. 860.7 and an identification of the 
risks to health, if any, presented by the device.



Sec. 860.95  Exemptions from sections 510, 519, and 520(f) of the act.

    (a) A panel recommendation to the Commissioner that a device be 
classified or reclassified into class I will include a recommendation as 
to whether the device should be exempted from some or all of the 
requirements of one or more of the following sections of the act: 
Section 510 (registration, product listing and premarket notification), 
section 519 (records and reports), and section 520(f) (good 
manufacturing practice regulations).
    (b) A regulation or an order classifying or reclassifying a device 
into class I will specify which requirements, if any, of sections 510, 
519, and 520(f) of the act the device is to be exempted from, together 
with the reasons for such exemption.
    (c) The Commissioner will grant exemptions under this section only 
if the Commissioner determines that the requirements from which the 
device is exempted are not necessary to provide reasonable assurance of 
the safety and effectiveness of the device.



                       Subpart C--Reclassification



Sec. 860.120  General.

    (a) Sections 513(e) and (f), 514(b), 515(b), and 520(l) of the act 
provide for reclassification of a device and prescribe the procedures to 
be followed to effect reclassification. The purposes of subpart C are 
to:
    (1) Set forth the requirements as to form and content of petitions 
for reclassification;
    (2) Describe the circumstances in which each of the five statutory 
reclassification provisions applies; and
    (3) Explain the procedure for reclassification prescribed in the 
five statutory reclassification provisions.
    (b) The criteria for determining the proper class for a device are 
set forth in Sec. 860.3(c). The reclassification of any device within a 
generic type of device causes the reclassification of all substantially 
equivalent devices within that generic type. Accordingly, a petition for 
the reclassification of a specific device will be considered a petition 
for reclassification of all substantially equivalent devices within the 
same generic type.
    (c) Any interested person may submit a petition for reclassification 
under section 513(e), 514(b), or 515(b). A manufacturer or importer may 
submit a petition for reclassification under section 513(f) or 520(l). 
The Commissioner may initiate the reclassification of a device

[[Page 165]]

classified into class III under sections 513(f) and 520(l) of the act.

[43 FR 32993, July 28, 1978, as amended at 57 FR 58404, Dec. 10, 1992]



Sec. 860.123  Reclassification petition: Content and form.

    (a) Unless otherwise provided in writing by the Commissioner, any 
petition for reclassification of a device, regardless of the section of 
the act under which it is filed, shall include the following:
    (1) A specification of the type of device for which reclassification 
is requested;
    (2) A statement of the action requested by the petitioner, e.g., 
``It is requested that __ device(s) be reclassified from class III to a 
class II'';
    (3) A completed supplemental data sheet applicable to the device for 
which reclassification is requested;
    (4) A completed classification questionnaire applicable to the 
device for which reclassification is requested;
    (5) A statement of the basis for disagreement with the present 
classification status of the device;
    (6) A full statement of the reasons, together with supporting data 
satisfying the requirements of Sec. 860.7, why the device should not be 
classified into its present classification and how the proposed 
classification will provide reasonable assurance of the safety and 
effectiveness of the device;
    (7) Representative data and information known by the petitioner that 
are unfavorable to the petitioner's position;
    (8) If the petition is based upon new information under section 
513(e), 514(b), or 515(b) of the act, a summary of the new information;
    (9) Copies of source documents from which new information used to 
support the petition has been obtained (attached as appendices to the 
petition).
    (10) A financial certification or disclosure statement or both as 
required by part 54 of this chapter.
    (b) Each petition submitted pursuant to this section shall be:
    (1) Addressed to the Food and Drug Administration, Center for 
Devices and Radiological Health, Regulations Staff (HFZ-215), 1350 
Piccard Dr., Rockville, MD 20857;
    (2) Marked clearly with the section of the act under which the 
petition is being submitted, i.e., ``513(e),'' ``513(f),'' ``514(b),'' 
``515(b),'' or ``520(l) Petition'';
    (3) Bound in a volume or volumes, where necessary; and
    (4) Submitted in an original and two copies.

[43 FR 32993, July 28, 1978, as amended at 49 FR 14505, Apr. 12, 1984; 
53 FR 11253, Apr. 6, 1988; 55 FR 11169, Mar. 27, 1990; 63 FR 5254, Feb. 
2, 1998; 65 FR 17137, Mar. 31, 2000]



Sec. 860.125  Consultation with panels.

    (a) When the Commissioner is required to refer a reclassification 
petition to a classification panel for its recommendation under 
Sec. 860.134, or is required, or chooses, to consult with a panel 
concerning a reclassification petition, such as under Sec. 860.130, 
Sec. 860.132, or Sec. 860.136, the Commissioner will distribute a copy 
of the petition, or its relevant portions, to each panel member and will 
consult with the panel in one of the following ways:
    (1) Consultation by telephone with at least a majority of current 
voting panel members and, when possible, nonvoting panel members;
    (2) Consultation by mail with at least a majority of current voting 
panel members and, when possible, nonvoting panel members; and
    (3) Discussion at a panel meeting.
    (b) The method of consultation chosen by the Commissioner will 
depend upon the importance and complexity of the subject matter involved 
and the time available for action. When time and circumstances permit, 
the Commissioner will consult with a panel through discussion at a panel 
meeting.
    (c) When a petition is submitted under Sec. 860.134 for a post-
enactment, not substantially equivalent device (``new device''), in 
consulting with the panel the Commissioner will obtain a recommendation 
that includes the information described in Sec. 860.84(d). In consulting 
with a panel about a petition submitted under Sec. 860.130, 
Sec. 860.132, or Sec. 860.136, the Commissioner may or may not obtain a 
formal recommendation.

[[Page 166]]



Sec. 860.130  General procedures under section 513(e) of the act.

    (a) Section 513(e) of the act applies to reclassification 
proceedings under the act based upon new information.
    (b) A proceeding to reclassify a device under section 513(e) may be 
initiated:
    (1) On the initiative of the Commissioner alone;
    (2) On the initiative of the Commissioner in response to a request 
for change in classification based upon new information, under section 
514(b) or 515(b) of the act (see Sec. 860.132); or
    (3) In response to the petition of an interested person, based upon 
new information, filed in accordance with Sec. 860.123.
    (c) By regulation promulgated under this section, the Commissioner 
may change the classification from class III into:
    (1) Class II if the Commissioner determines that special controls in 
addition to general controls would provide reasonable assurance of the 
safety and effectiveness of the device and there is sufficient 
information to establish special controls to provide assurance; or
    (2) Class I if the Commissioner determines that general controls 
would provide reasonable assurance of the safety and effectiveness of 
the device.
    (d) The rulemaking procedures in Sec. 10.40 of this chapter apply to 
proceedings to reclassify a device under section 513(e), except that the 
Commissioner may secure a recommendation with respect to a proposed 
reclassification from the classification panel to which the device was 
last referred. The panel will consider a proposed reclassification 
submitted to it by the Commissioner in accordance with the consultation 
procedures of Sec. 860.125. Any recommendation submitted to the 
Commissioner by the panel will be published in the Federal Register when 
the Commissioner promulgates a regulation under this section.
    (e) Within 180 days after the filing of a petition for 
reclassification under this section, the Commissioner, by order 
published in the Federal Register, will either deny the petition or give 
notice of his intent to initiate a change in the classification of the 
device.
    (f) If a device is reclassified under this section, the regulation 
effecting the reclassification may revoke any special control or 
premarket approval requirement that previously applied to the device but 
that is no longer applicable because of the change in classification.
    (g) A regulation under this section changing the classification of a 
device from class III to class II may provide that such classification 
will not take effect until the effective date of a special control for 
the device established under section 514 of the act.

[43 FR 32993, July 28, 1978, as amended at 57 FR 58404, Dec. 10, 1992]



Sec. 860.132  Procedures when the Commissioner initiates a performance standard or premarket approval proceeding under section 514(b) or 515(b) of the act.

    (a) Sections 514(b) and 515(b) of the act require the Commissioner 
to provide, by notice in the Federal Register, an opportunity for 
interested parties to request a change in the classification of a device 
based upon new information relevant to its classification when the 
Commissioner initiates a proceeding either to develop a performance 
standard for the device if in class II, or to promulgate a regulation 
requiring premarket approval for the device if in class III. In either 
case, if the Commissioner agrees that the new information warrants a 
change in classification, the Commissioner will publish in the Federal 
Register notice of the Commissioner's intent to initiate a proceeding 
under section 513(e) of the act and Sec. 860.130 to effect such a 
change.
    (b) The procedures for effecting a change in classification under 
sections 514(b) and 515(b) of the act are as follows:
    (1) Within 15 days after publication of the Commissioner's notice 
referred to in paragraph (a) of this section, an interested person files 
a petition for reclassification in accordance with Sec. 860.123.
    (2) The Commissioner consults with the appropriate classification 
panel with regard to the petition in accordance with Sec. 860.125.
    (3) Within 60 days after publication of the notice referred to in 
paragraph (a)

[[Page 167]]

of this section, the Commissioner, by order published in the Federal 
Register, either denies the petition or gives notice of his intent to 
initiate a change in classification in accordance with Sec. 860.130.



Sec. 860.134  Procedures for ``new devices'' under section 513(f) of the act and reclassification of certain devices.

    (a) Section 513(f)(2) of the act applies to proceedings for 
reclassification of a device currently in class III by operation of 
section 513(f)(1) of the act. This category includes any device that is 
to be first introduced or delivered for introduction into interstate 
commerce for commercial distribution after May 28, 1976, unless:
    (1) It is substantially equivalent to another device that was in 
commercial distribution before that date and had not been regulated 
before that date as a new drug; or
    (2) It is substantially equivalent to another device that was not in 
commercial distribution before such date but which has been classified 
into class I or class II; or
    (3) The Commissioner has classified the device into class I or class 
II in response to a petition for reclassification under this section.

The Commissioner determines whether a device is ``substantially 
equivalent'' for purposes of the application of this section. If a 
manufacturer or importer believes that a device is not ``substantially 
equivalent'' but that it should not be in class III under the criteria 
in Sec. 860.3(c), the manufacturer or importer may petition for 
reclassification under this section. A manufacturer or importer who 
believes that a device is ``substantially equivalent'' and wishes to 
proceed to market the device shall submit a premarket notification in 
accordance with part 807 of this chapter. After considering a premarket 
notification, the Commissioner will determine whether the device is 
``substantially equivalent'' and will notify the manufacturer or 
importer of such determination in accordance with part 807 of this 
chapter.
    (b) The procedures for effecting reclassification under section 
513(f) of the act are as follows:
    (1) The manufacturer or importer of the device petitions for 
reclassification of the device in accordance with Sec. 860.123.
    (2) Within 30 days after the petition is filed, the Commissioner 
notifies the petitioner of any deficiencies in the petition that prevent 
the Commissioner from making a decision on it and allows the petitioner 
to supplement a deficient petition. Within 30 days after any 
supplemental material is received, the Commissioner notifies the 
petitioner whether the petition, as supplemented, is adequate for 
review.
    (3) After determining that the petition contains no deficiencies 
precluding a decision on it, the Commissioner may for good cause shown 
refer the petition to the appropriate classification panel for its 
review and recommendation whether to approve or deny the petition.
    (4) Within 90 days after the date the petition is referred to the 
panel, following the review procedures set forth in Sec. 860.84(c) for 
the original classification of an ``old'' device, the panel submits to 
the Commissioner its recommendation containing the information set forth 
in Sec. 860.84(d). A panel recommendation is regarded as preliminary 
until the Commissioner has reviewed it, discussed it with the panel, if 
appropriate, and developed a proposed reclassification order. 
Preliminary panel recommendations are filed in the Dockets Management 
Branch upon receipt and are available to the public upon request.
    (5) The panel recommendation is published in the Federal Register as 
soon as practicable and interested persons are provided an opportunity 
to comment on the recommendation.
    (6) Within 90 days after the panel's recommendation is received (and 
no more than 210 days after the date the petition was filed), the 
Commissioner denies or approves the petition by order in the form of a 
letter to the petitioner. If the Commissioner approves the petition, the 
order will classify the device into class I or class II in accordance 
with the criteria set forth in Sec. 860.3(c) and subject to the 
applicable requirements of Sec. 860.93, relating to the classification 
of implants, life-supporting or life-sustaining devices, and

[[Page 168]]

Sec. 860.95, relating to exemptions from certain requirements of the 
act.
    (7) Within a reasonable time after issuance of an order under this 
section, the Commissioner announces the order by notice published in the 
Federal Register.

[43 FR 32993, July 28, 1978, as amended at 57 FR 58404, Dec. 10, 1992]



Sec. 860.136  Procedures for transitional products under section 520(l) of the act.

    (a) Section 520(l)(2) of the act applies to reclassification 
proceedings initiated by a manufacturer or importer for reclassification 
of a device currently in class III by operation of section 520(l)(1) of 
the act. This section applies only to devices that the Food and Drug 
Administration regarded as ``new drugs'' before May 28, 1976.
    (b) The procedures for effecting reclassification under section 
520(l) are as follows:
    (1) The manufacturer or importer of the device files a petition for 
reclassification of the device in accordance with Sec. 860.123.
    (2) Within 30 days after the petition is filed, the Commissioner 
notifies the petitioner of any deficiencies in the petition that prevent 
the Commissioner from making a decision on it, allowing the petitioner 
to supplement a deficient petition. Within 30 days after any 
supplemental material is received, the Commissioner notifies the 
petitioner whether the petition, as supplemented, is adequate for 
review.
    (3) The Commissioner provides the petitioner an opportunity for a 
regulatory hearing conducted in accordance with part 16 of this chapter.
    (4) The Commissioner consults with the appropriate classification 
panel with regard to the petition in accordance with Sec. 860.125.
    (5) Within 180 days after the petition is filed (where the 
Commissioner has determined it to be adequate for review), the 
Commissioner, by order in the form of a letter to the petitioner, either 
denies the petition or classifies the device into class I or class II in 
accordance with the criteria set forth in Sec. 860.3(c).
    (6) Within a reasonable time after issuance of an order under this 
section, the Commissioner announces the order by notice published in the 
Federal Register.



PART 861--PROCEDURES FOR PERFORMANCE STANDARDS DEVELOPMENT--Table of Contents




                           Subpart A--General

Sec.
861.1  Purpose and scope.
861.5  Statement of policy.
861.7  Contents of standards.

    Subpart B--Procedures for Performance Standards Development and 
                               Publication

861.20  Summary of standards development process.
861.24  Existing standard as a proposed standard.
861.30  Development of standards.
861.34  Amendment or revocation of a standard.
861.36  Effective dates.
861.38  Standards advisory committees.

    Authority: 21 U.S.C. 351, 352, 360c, 360d, 360gg-360ss, 371, 374; 42 
U.S.C. 262, 264.

    Source: 45 FR 7484, Feb. 1, 1980, unless otherwise noted.



                           Subpart A--General



Sec. 861.1  Purpose and scope.

    (a) This part implements section 514 of the Federal Food, Drug, and 
Cosmetic Act (the act) with respect to the establishment, amendment, and 
revocation of performance standards applicable to devices intended for 
human use.
    (b) The Food and Drug Administration may determine that a 
performance standard, as described under special controls for class II 
devices in Sec. 860.7(b) of this chapter, is necessary to provide 
reasonable assurance of the safety and effectiveness of the device. 
Performance standards may be established for:
    (1) A class II device;
    (2) A class III device which, upon the effective date of the 
standard, is reclassified into class II; and
    (3) A class III device, as a condition to premarket approval under 
section 515 of the act, to reduce or eliminate a risk or risks 
associated with such device.

[[Page 169]]

    (c) References in this part to regulatory sections of the Code of 
Federal Regulations are to chapter I of title 21 unless otherwise noted.

[45 FR 7484, Feb. 1, 1980, as amended at 45 FR 23686, Apr. 8, 1980; 57 
FR 58404, Dec. 10, 1992]



Sec. 861.5  Statement of policy.

    In carrying out its duties under this section, the Food and Drug 
Administration will, to the maximum extent practical:
    (a) Use personnel, facilities, and other technical support available 
in other Federal agencies;
    (b) Consult with other Federal agencies concerned with standard 
setting and other nationally or internationally recognized standard-
setting entities; and
    (c) Invite participation, through conferences, workshops, or other 
means, by representatives of scientific, professional, industry, or 
consumer organizations who can make a significant contribution.



Sec. 861.7  Contents of standards.

    Any performance standard established under this part will include 
such provisions as the Food and Drug Administration determines are 
necessary to provide reasonable assurance of the safety and 
effectiveness of the device or devices for which it is established. 
Where necessary to provide such assurance, a standard will address (but 
need not be limited to):
    (a) Performance characteristics of the device;
    (b) The design, construction, components, ingredients, and 
properties of the device, and its compatibility with power systems and 
connections to such systems;
    (c) The manufacturing processes and quality control procedures 
applicable to the device;
    (d) Testing of the device on either a sample or a 100-percent basis 
by the manufacturer, or, if it is determined that no other more 
practical means are available to the Food and Drug Administration to 
assure the conformity of the device to the standard, providing for 
testing by the Food and Drug Administration or a third person to ensure 
that the device conforms to the standard;
    (e) The publication of the results of each test or of certain tests 
of the device to show that the device conforms to the portions of the 
standard for which the test or tests were required;
    (f) Manufacturers' certification to purchasers or to the Food and 
Drug Administration that the device conforms to the applicable 
performance standard;
    (g) Restrictions on the sale and distribution of the device, but 
only to the extent authorized under section 520(e) of the act;
    (h) The use, and the form and content, of labeling for the proper 
installation, maintenance, operation, and use of the device. Among the 
provisions that may be required in the labeling are warnings; storage 
and transportation information; expiration dates; the date and place of 
manufacture; the results that may be expected if the device is used 
properly; the ranges of accuracy of diagnostic information; instructions 
regarding the proper care of, and the proper components, accessories, or 
other equipment to be used with the device; and statements concerning 
the appropriate patient population, for example, a statement that the 
device is considered safe and effective only when used by, or in the 
treatment of, a patient who has been tested by particular designated 
procedures and found to have an illness or condition for which use of 
the device is indicated by a person skilled in the use of the device.



    Subpart B--Procedures for Performance Standards Development and 
                               Publication



Sec. 861.20  Summary of standards development process.

    The procedure by which a performance standard for a device may be 
established, amended, or revoked is as follows:
    (a) The Food and Drug Administration (FDA) will publish in the 
Federal Register a notice of proposed rulemaking for the establishment, 
amendment, or revocation of any performance standard for a device.
    (1) A notice of proposed rulemaking for the establishment or 
amendment of

[[Page 170]]

a performance standard for a device will:
    (i) Set forth a finding, with supporting justification, that the 
performance standard is appropriate and necessary to provide reasonable 
assurance of the safety and effectiveness of the device;
    (ii) Set forth proposed findings with respect to the risk of illness 
or injury that the performance standard is intended to reduce or 
eliminate;
    (iii) Invite interested persons to submit to the Food and Drug 
Administration, within 30 days of the publication of the notice, 
requests for changes in the classification of the device pursuant to 
Sec. 860.132 of this chapter, based on new information relevant to the 
classification; and
    (iv) Invite interested persons to submit an existing performance 
standard for the device, including a draft or proposed performance 
standard, for consideration by the Commissioner of Food and Drugs.
    (2) A notice of proposed rulemaking for the revocation of a 
performance standard will set forth a finding, with supporting 
justification, that the performance standard is no longer necessary to 
provide reasonable assurance of the safety and effectiveness of a 
device.
    (b) A notice under this section will provide for a comment period of 
not less than 60 days.
    (c) If, after publication of a notice under paragraph (a) of this 
section, FDA receives a request to change the classification of the 
device, FDA will, within 60 days of the publication of the notice and 
after consultation with the appropriate panel under Sec. 860.125 of this 
chapter, either deny the request or give notice of its intent to 
initiate a change in the classification under Sec. 860.130.
    (d) If FDA initiates a rulemaking proceeding under paragraph (a) of 
this section, FDA will:
    (1) Complete the proceeding and establish the performance standard 
for the device in accordance with this part and Sec. 10.40 of this 
chapter; or
    (2) Terminate the proceeding by publishing in the Federal Register a 
notice announcing such termination and the reasons therefor and, unless 
the proceeding is terminated because the device is a banned device, 
initiate a proceeding in accordance with section 513(e) of the act to 
reclassify the device; or
    (3) Take other appropriate action.

[57 FR 58404, Dec. 10, 1992]



Sec. 861.24  Existing standard as a proposed standard.

    (a) The Food and Drug Administration may accept an existing standard 
or a proposed or draft standard if it includes:
    (1) A description of the procedures used to develop the standard and 
a list of the persons and organizations that participated in its 
development, to the extent that such information is available or 
reasonably obtainable;
    (2) An identification of the specific portions of the existing 
standard that the person submitting the standard believes are 
appropriate for adoption as, or inclusion in, the proposed standard; and
    (3) A summary of the test data, or, if requested by the Food and 
Drug Administration, all such data or other information supporting the 
specific portions of the standard identified by the person submitting 
the standard.
    (b) The Food and Drug Administration will publish a notice in the 
Federal Register stating either that it has accepted, or accepted with 
modification, as a proposed standard, an existing standard or one that 
has been developed, or that an existing standard is not acceptable, 
together with the reasons therefor.

[45 FR 7484, Feb. 1, 1980, as amended at 57 FR 58405, Dec. 10, 1992]



Sec. 861.30  Development of standards.

    The Food and Drug Administration (FDA), while engaged in the 
development of a proposed standard under this section will:
    (a) Support its proposed performance standard by such test data or 
other documents or materials as may reasonably be required;
    (b) Provide interested persons an opportunity to participate in the 
development of the standard by accepting comments and, where 
appropriate, holding public meetings on issues relating to development 
of the standard.

[[Page 171]]

Notice of the opportunity to participate in the development of the 
standard will be furnished in a manner reasonably calculated to reach 
the majority of persons interested in the development of the standard. 
This requirement shall be satisfied by publishing such a notice in the 
Federal Register. Whenever it is appropriate, FDA will use the Federal 
Register to make announcements about the standard development process of 
standard developers other than Federal agencies.
    (c) Maintain records disclosing the course of development of the 
proposed standard, the comments and other information submitted by a 
person in connection with such development (including comments and 
information regarding the need for a standard), and such other 
information as may be required to evaluate the standard.

[45 FR 7484, Feb. 1, 1980, as amended at 57 FR 58405, Dec. 10, 1992]



Sec. 861.34  Amendment or revocation of a standard.

    (a) The Food and Drug Administration will provide for periodic 
evaluation of performance standards to determine whether such standards 
should be changed to reflect new medical, scientific, or other 
technological data.
    (b) The Food and Drug Administration may, on its own initiative or 
upon petition of an interested party, amend or revoke by regulation a 
standard established under this part.
    (c) Any petition to amend or revoke a standard shall:
    (1) Identify the specific device and standard for which the 
amendment or revocation is sought; and
    (2) Be submitted in accordance with the requirements of Sec. 10.30.
    (d) Proceedings to amend or revoke a performance standard shall be 
conducted in accordance with the rulemaking procedures of Sec. 10.40. In 
addition, a notice of proposed rulemaking to amend or revoke a standard 
shall set forth proposed findings with respect to the degree of risk or 
illness to be eliminated or reduced and the benefit the public will 
derive from the proposed amendment or revocation.



Sec. 861.36  Effective dates.

    (a) A regulation establishing, amending, or revoking a performance 
standard will set forth the date upon which it will take effect. To the 
extent practical, consistent with the public health and safety, such 
effective date will be established so as to minimize economic loss to, 
and disruption or dislocation of, domestic and international trade.
    (b) Except as provided in paragraph (c) of this section, no 
regulation establishing, amending, or revoking a standard may take 
effect before 1 year after the date of its publication unless:
    (1) The Food and Drug Administration determines that an earlier 
effective date is necessary to protect the public health and safety; or
    (2) The standard has been established for a device that, by the 
effective date of the standard, has been reclassified from class III to 
class II.
    (c) The Food and Drug Administration may declare a proposed 
regulation amending a standard effective on publication in the Federal 
Register if it determines that making the regulation so effective is in 
the public interest. A proposed amendment of a performance standard made 
effective upon publication may not prohibit the introduction or delivery 
for introduction into interstate commerce of a device that conforms to 
the standard without the change or changes provided in the proposed 
amendment until the effective date of any final action on the proposal.

[45 FR 7484, Feb. 1, 1980, as amended at 57 FR 58405, Dec. 10, 1992]



Sec. 861.38  Standards advisory committees.

    (a) The Food and Drug Administration will establish advisory 
committees to which proposed regulations may be referred, and these 
committees shall consider such referrals in accordance with this section 
and part 14 of this chapter. Such advisory committees, which may not be 
classification panels, shall be considered ad hoc advisory committees. 
Their members shall be selected in accordance with Secs. 14.82 and 
14.84, except that no member may be a regular full-time FDA employee. 
Each advisory committee established under

[[Page 172]]

this section shall include as nonvoting members a representative of 
consumer interests and a representative of interests of the device 
manufacturing industry.
    (b) A proposed regulation to establish, amend, or revoke a 
performance standard shall be referred to an advisory committee for a 
report and recommendation with respect to any matter involved in the 
proposed regulation which requires the exercise of scientific judgment 
if:
    (1) The Food and Drug Administration determines that such referral 
is necessary or appropriate under the circumstances; or
    (2) Requested by an interested person, in the form of a citizen 
petition in accordance with Sec. 10.30 of this chapter, which is made 
within the period provided for comment on the proposed regulation and 
which demonstrates good cause for referral.
    (c) When a proposed regulation is referred to an advisory committee, 
the Food and Drug Administration will furnish the committee with the 
data and information upon which the proposed regulation is based. After 
independently reviewing the materials furnished by the Food and Drug 
Administration and any other available data and information, the 
advisory committee shall, within 60 days of the referral, submit a 
report and recommendation on the proposed regulation, together with all 
underlying data and information and a statement of the reason or basis 
for the recommendation. A copy of the report and recommendation will be 
publicly displayed in the office of the Dockets Management Branch, Food 
and Drug Administration.
    (d) Where appropriate, each proposed regulation establishing a 
standard published in the Federal Register will include a call for 
nominations to the advisory committee for that particular standard.

[45 FR 7484, Feb. 1, 1980, as amended at 57 FR 58405, Dec. 10, 1992]



PART 862--CLINICAL CHEMISTRY AND CLINICAL TOXICOLOGY DEVICES--Table of Contents




                      Subpart A--General Provisions

Sec.
862.1  Scope.
862.2  Regulation of calibrators.
862.3  Effective dates of requirement for premarket approval.
862.9  Limitations of exemptions from section 510(k) of the Federal 
          Food, Drug, and Cosmetic Act (the act).

               Subpart B--Clinical Chemistry Test Systems

862.1020  Acid phosphatase (total or prostatic) test system.
862.1025  Adrenocorticotropic hormone (ACTH) test system.
862.1030  Alanine amino transferase (ALT/SGPT) test system.
862.1035  Albumin test system.
862.1040  Aldolase test system.
862.1045  Aldosterone test system.
862.1050  Alkaline phosphatase or isoenzymes test system.
862.1060  Delta-aminolevulinic acid test system.
862.1065  Ammonia test system.
862.1070  Amylase test system.
862.1075  Androstenedione test system.
862.1080  Androsterone test system.
862.1085  Angiotensin I and renin test system.
862.1090  Angiotensin converting enzyme (A.C.E.) test system.
862.1095  Ascorbic acid test system.
862.1100  Aspartate amino transferase (AST/SGOT) test system.
862.1110  Bilirubin (total or direct) test system.
862.1113  Bilirubin (total and unbound) in the neonate test system.
862.1115  Urinary bilirubin and its conjugates (nonquantitative) test 
          system.
862.1118  Biotinidase test system.
862.1120  Blood gases (PCO2PO2) and blood pH test 
          system.
862.1130  Blood volume test system.
862.1135  C-peptides of proinsulin test system.
862.1140  Calcitonin test system.
862.1145  Calcium test system.
862.1150  Calibrator.
862.1155  Human chorionic gonadotropin (HCG) test system.
862.1160  Bicarbonate/carbon dioxide test system.
862.1165  Catecholamines (total) test system.
862.1170  Chloride test system.
862.1175  Cholesterol (total) test system.

[[Page 173]]

862.1177  Cholylglycine test system.
862.1180  Chymotrypsin test system.
862.1185  Compound S (11-deoxycortisol) test system.
862.1187  Conjugated sulfolithocholic acid (SLCG) test system.
862.1190  Copper test system.
862.1195  Corticoids test system.
862.1200  Corticosterone test system.
862.1205  Cortisol (hydrocortisone and hydroxycorticosterone) test 
          system.
862.1210  Creatine test system.
862.1215  Creatine phosphokinase/creatine kinase or isoenzymes test 
          system.
862.1225  Creatinine test system.
862.1230  Cyclic AMP test system.
862.1240  Cystine test system.
862.1245  Dehydroepiandrosterone (free and sulfate) test system.
862.1250  Desoxycorticosterone test system.
862.1255  2,3-Diphosphoglyceric acid test system.
862.1260  Estradiol test system.
862.1265  Estriol test system.
862.1270  Estrogens (total, in pregnancy) test system.
862.1275  Estrogens (total, nonpregnancy) test system.
862.1280  Estrone test system.
862.1285  Etiocholanolone test system.
862.1290  Fatty acids test system.
862.1295  Folic acid test system.
862.1300  Follicle-stimulating hormone test system.
862.1305  Formiminoglutamic acid (FIGLU) test system.
862.1310  Galactose test system.
862.1315  Galactose-1-phosphate uridyl transferase test system.
862.1320  Gastric acidity test system.
862.1325  Gastrin test system.
862.1330  Globulin test system.
862.1335  Glucagon test system.
862.1340  Urinary glucose (nonquantitative) test system.
862.1345  Glucose test system.
862.1360  Gamma-glutamyl transpeptidase and isoenzymes test system.
862.1365  Glutathione test system.
862.1370  Human growth hormone test system.
862.1375  Histidine test system.
862.1377  Urinary homocystine (nonquantitative) test system.
862.1380  Hydroxybutyric dehydrogenase test system.
862.1385  17-Hydroxycorticosteroids (17-ketogenic steroids) test system.
862.1390  5-Hydroxyindole acetic acid/serotonin test system.
862.1395  17-Hydroxyprogesterone test system.
862.1400  Hydroxyproline test system.
862.1405  Immunoreactive insulin test system.
862.1410  Iron (non-heme) test system.
862.1415  Iron-binding capacity test system.
862.1420  Isocitric dehydrogenase test system.
862.1430  17-Ketosteroids test system.
862.1435  Ketones (nonquantitative) test system.
862.1440  Lactate dehydrogenase test system.
862.1445  Lactate dehydrogenase isoenzymes test system.
862.1450  Lactic acid test system.
862.1455  Lecithin/sphingomyelin ratio in amniotic fluid test system.
862.1460  Leucine aminopeptidase test system.
862.1465  Lipase test system.
862.1470  Lipid (total) test system.
862.1475  Lipoprotein test system.
862.1485  Luteinizing hormone test system.
862.1490  Lysozyme (muramidase) test system.
862.1495  Magnesium test system.
862.1500  Malic dehydrogenase test system.
862.1505  Mucopolysaccharides (nonquantitative) test system.
862.1509  Methylmalonic acid (nonquantitative) test system.
862.1510  Nitrite (nonquantitative) test system.
862.1515  Nitrogen (amino-nitrogen) test system.
862.1520  5'-Nucleotidase test system.
862.1530  Plasma oncometry test system.
862.1535  Ornithine carbamyl transferase test system.
862.1540  Osmolality test system.
862.1542  Oxalate test system.
862.1545  Parathyroid hormone test system.
862.1550  Urinary pH (nonquantitative) test system.
862.1555  Phenylalanine test system.
862.1560  Urinary phenylketones (nonquantitative) test system.
862.1565  6-Phosphogluconate dehydrogenase test system.
862.1570  Phosphohexose isomerase test system.
862.1575  Phospholipid test system.
862.1580  Phosphorus (inorganic) test system.
862.1585  Human placental lactogen test system.
862.1590  Porphobilinogen test system.
862.1595  Porphyrins test system.
862.1600  Potassium test system.
862.1605  Pregnanediol test system.
862.1610  Pregnanetriol test system.
862.1615  Pregnenolone test system.
862.1620  Progesterone test system.
862.1625  Prolactin (lactogen) test system.
862.1630  Protein (fractionation) test system.
862.1635  Total protein test system.
862.1640  Protein-bound iodine test system.
862.1645  Urinary protein or albumin (nonquantitative) test system.
862.1650  Pyruvate kinase test system.
862.1655  Pyruvic acid test system.
862.1660  Quality control material (assayed and unassayed).
862.1665  Sodium test system.

[[Page 174]]

862.1670  Sorbitol dehydrogenase test system.
862.1675  Blood specimen collection device.
862.1680  Testosterone test system.
862.1685  Thyroxine-binding globulin test system.
862.1690  Thyroid-stimulating hormone test system.
862.1695  Free thyroxine test system.
862.1700  Total thyroxine test system.
862.1705  Triglyceride test system.
862.1710  Total triiodothyronine test system.
862.1715  Triiodothyronine uptake test system.
862.1720  Triose phosphate isomerase test system.
862.1725  Trypsin test system.
862.1730  Free tyrosine test system.
862.1770  Urea nitrogen test system.
862.1775  Uric acid test system.
862.1780  Urinary calculi (stones) test system.
862.1785  Urinary urobilinogen (nonquantitative) test system.
862.1790  Uroporphyrin test system.
862.1795  Vanilmandelic acid test system.
862.1805  Vitamin A test system.
862.1810  Vitamin B 12 test system.
862.1815  Vitamin E test system.
862.1820  Xylose test system.
862.1825  Vitamin D test system.

               Subpart C--Clinical Laboratory Instruments

862.2050  General purpose laboratory equipment labeled or promoted for a 
          specific medical use.
862.2100  Calculator/data processing module for clinical use.
862.2140  Centrifugal chemistry analyzer for clinical use.
862.2150  Continuous flow sequential multiple chemistry analyzer for 
          clinical use.
862.2160  Discrete photometric chemistry analyzer for clinical use.
862.2170  Micro chemistry analyzer for clinical use.
862.2230  Chromatographic separation material for clinical use.
862.2250  Gas liquid chromatography system for clinical use.
862.2260  High pressure liquid chromatography system for clinical use.
862.2270  Thin-layer chromatography system for clinical use.
862.2300  Colorimeter, photometer, or spectrophotometer for clinical 
          use.
862.2310  Clinical sample concentrator.
862.2320  Beta or gamma counter for clinical use.
862.2400  Densitometer/scanner (integrating, reflectance, TLC, or 
          radiochromatogram) for clinical use.
862.2485  Electrophoresis apparatus for clinical use.
862.2500  Enzyme analyzer for clinical use.
862.2540  Flame emission photometer for clinical use.
862.2560  Fluorometer for clinical use.
862.2680  Microtitrator for clinical use.
862.2700  Nephelometer for clinical use.
862.2720  Plasma oncometer for clinical use.
862.2730  Osmometer for clinical use.
862.2750  Pipetting and diluting system for clinical use.
862.2800  Refractometer for clinical use.
862.2850  Atomic absorption spectrophotometer for clinical use.
862.2860  Mass spectrometer for clinical use.
862.2900  Automated urinalysis system.
862.2920  Plasma viscometer for clinical use.

               Subpart D--Clinical Toxicology Test Systems

862.3030  Acetaminophen test system.
862.3035  Amikacin test system.
862.3040  Alcohol test system.
862.3050  Breath-alcohol test system.
862.3100  Amphetamine test system.
862.3110  Antimony test system.
862.3120  Arsenic test system.
862.3150  Barbiturate test system.
862.3170  Benzodiazepine test system.
862.3200  Clinical toxicology calibrator.
862.3220  Carbon monoxide test system.
862.3240  Cholinesterase test system.
862.3250  Cocaine and cocaine metabolite test system.
862.3270  Codeine test system.
862.3280  Clinical toxicology control material.
862.3300  Digitoxin test system.
862.3320  Digoxin test system.
862.3350  Diphenylhydantoin test system.
862.3380  Ethosuximide test system.
862.3450  Gentamicin test system.
862.3520  Kanamycin test system.
862.3550  Lead test system.
862.3555  Lidocaine test system.
862.3560  Lithium test system.
862.3580  Lysergic acid diethylamide (LSD) test system.
862.3600  Mercury test system.
862.3610  Methamphetamine test system.
862.3620  Methadone test system.
862.3630  Methaqualone test system.
862.3640  Morphine test system.
862.3645  Neuroleptic drugs radioreceptor assay test system.
862.3650  Opiate test system.
862.3660  Phenobarbital test system.
862.3670  Phenothiazine test system.
862.3680  Primidone test system.
862.3700  Propoxyphene test system.
862.3750  Quinine test system.
862.3830  Salicylate test system.
862.3850  Sulfonamide test system.
862.3870  Cannabinoid test system.
862.3880  Theophylline test system.
862.3900  Tobramycin test system.
862.3910  Tricyclic antidepressant drugs test system.

[[Page 175]]

862.3950  Vancomycin test system.

    Authority: 21 U.S.C. 351, 360, 360c, 360e, 360j, 371.

    Source: 52 FR 16122, May 1, 1987, unless otherwise noted.



                      Subpart A--General Provisions



Sec. 862.1  Scope.

    (a) This part sets forth the classification of clinical chemistry 
and clinical toxicology devices intended for human use that are in 
commercial distribution.
    (b) The identification of a device in a regulation in this part is 
not a precise description of every device that is, or will be, subject 
to the regulation. A manufacturer who submits a premarket notification 
submission for a device under part 807 cannot show merely that the 
device is accurately described by the section title and identification 
provisions of a regulation in this part, but shall state why the device 
is substantially equivalent to other devices, as required in 
Sec. 807.87.
    (c) References in this part to regulatory sections of the Code of 
Federal Regulations are to chapter I of title 21 unless otherwise noted.



Sec. 862.2  Regulation of calibrators.

    Many devices classified in this part are intended to be used with a 
calibrator. A calibrator has a reference value assigned to it which 
serves as the basis by which test results of patients are derived or 
calculated. The calibrator for a device may be (a) manufactured and 
distributed separately from the device with which it is intended to be 
used, (b) manufactured and distributed as one of several device 
components, such as in a kit of reagents, or (c) built-in as an integral 
part of the device. Because of the central role that a calibrator plays 
in the measurement process and the critical effect calibrators have on 
accuracy of test results, elsewhere in this part, all three of these 
types of calibrators (Secs. 862.1150 and 862.3200 of this part) are 
classified into class II, notwithstanding the classification of the 
device with which it is intended to be used. Thus, a device and its 
calibrator may have different classifications, even if the calibrator is 
built into the device.



Sec. 862.3  Effective dates of requirement for premarket approval.

    A device included in this part that is classified into class III 
(premarket approval) shall not be commercially distributed after the 
date shown in the regulation classifying the device unless the 
manufacturer has an approval under section 515 of the act (unless an 
exemption has been granted under section 520(g)(2) of the act). An 
approval under section 515 of the act consists of FDA's issuance of an 
order approving an application for premarket approval (PMA) for the 
device or declaring completed a product development protocol (PDP) for 
the device.
    (a) Before FDA requires that a device commercially distributed 
before the enactment date of the amendments, or a device that has been 
found substantially equivalent to such a device, has an approval under 
section 515 of the act FDA must promulgate a regulation under section 
515(b) of the act requiring such approval, except as provided in 
paragraph (b) of this section. Such a regulation under section 515(b) of 
the act shall not be effective during the grace period ending on the 
90th day after its promulgation or on the last day of the 30th full 
calendar month after the regulation that classifies the device into 
class III is effective, whichever is later. See section 501(f)(2)(B) of 
the act. Accordingly, unless an effective date of the requirement for 
premarket approval is shown in the regulation for a device classified 
into class III in this part, the device may be commercially distributed 
without FDA's issuance of an order approving a PMA or declaring 
completed a PDP for the device. If FDA promulgates a regulation under 
section 515(b) of the act requiring premarket approval for a device, 
section 501(f)(1)(A) of the act applies to the device.
    (b) Any new, not substantially equivalent, device introduced into 
commercial distribution on or after May 28, 1976, including a device 
formerly marketed that has been substantially altered, is classified by 
statute (section 513(f) of the act) into class III without any grace 
period and FDA must have

[[Page 176]]

issued an order approving a PMA or declaring completed a PDP for the 
device before the device is commercially distributed unless it is 
reclassified. If FDA knows that a device being commercially distributed 
may be a ``new'' device as defined in this section because of any new 
intended use or other reasons, FDA may codify the statutory 
classification of the device into class III for such new use. 
Accordingly, the regulation for such a class III device states that as 
of the enactment date of the amendments, May 28, 1976, the device must 
have an approval under section 515 of the act before commercial 
distribution.



Sec. 862.9  Limitations of exemptions from section 510(k) of the Federal Food, Drug, and Cosmetic Act (the act).

    The exemption from the requirement of premarket notification 
(section 510(k) of the act) for a generic type of class I or II device 
is only to the extent that the device has existing or reasonably 
foreseeable characteristics of commercially distributed devices within 
that generic type or, in the case of in vitro diagnostic devices, only 
to the extent that misdiagnosis as a result of using the device would 
not be associated with high morbidity or mortality. Accordingly, 
manufacturers of any commercially distributed class I or II device for 
which FDA has granted an exemption from the requirement of premarket 
notification must still submit a premarket notification to FDA before 
introducing or delivering for introduction into interstate commerce for 
commercial distribution the device when:
    (a) The device is intended for a use different from the intended use 
of a legally marketed device in that generic type of device; e.g., the 
device is intended for a different medical purpose, or the device is 
intended for lay use where the former intended use was by health care 
professionals only;
    (b) The modified device operates using a different fundamental 
scientific technology than a legally marketed device in that generic 
type of device; e.g., a surgical instrument cuts tissue with a laser 
beam rather than with a sharpened metal blade, or an in vitro diagnostic 
device detects or identifies infectious agents by using deoxyribonucleic 
acid (DNA) probe or nucleic acid hybridization technology rather than 
culture or immunoassay technology; or
    (c) The device is an in vitro device that is intended:
    (1) For use in the diagnosis, monitoring, or screening of neoplastic 
diseases with the exception of immunohistochemical devices;
    (2) For use in screening or diagnosis of familial or acquired 
genetic disorders, including inborn errors of metabolism;
    (3) For measuring an analyte that serves as a surrogate marker for 
screening, diagnosis, or monitoring life-threatening diseases such as 
acquired immune deficiency syndrome (AIDS), chronic or active hepatitis, 
tuberculosis, or myocardial infarction or to monitor therapy;
    (4) For assessing the risk of cardiovascular diseases;
    (5) For use in diabetes management;
    (6) For identifying or inferring the identity of a microorganism 
directly from clinical material;
    (7) For detection of antibodies to microorganisms other than 
immunoglobulin G (IgG) or IgG assays when the results are not 
qualitative, or are used to determine immunity, or the assay is intended 
for use in matrices other than serum or plasma;
    (8) For noninvasive testing as defined in Sec. 812.3(k) of this 
chapter; and
    (9) For near patient testing (point of care).

[65 FR 2304, Jan. 14, 2000]



               Subpart B--Clinical Chemistry Test Systems



Sec. 862.1020  Acid phosphatase (total or prostatic) test system.

    (a) Identification. An acid phosphatase (total or prostatic) test 
system is a device intended to measure the activity of the acid 
phosphatase enzyme in plasma and serum.
    (b) Classification. Class II.



Sec. 862.1025  Adrenocorticotropic hormone (ACTH) test system.

    (a) Identification. An adrenocorticotropic hormone (ACTH) test 
system is

[[Page 177]]

a device intended to measure adrenocorticotropic hormone in plasma and 
serum. ACTH measurements are used in the differential diagnosis and 
treatment of certain disorders of the adrenal glands such as Cushing's 
syndrome, adrenocortical insufficiency, and the ectopic ACTH syndrome.
    (b) Classification. Class II.



Sec. 862.1030  Alanine amino transferase (ALT/SGPT) test system.

    (a) Identification. An alanine amino transferase (ALT/SGPT) test 
system is a device intended to measure the activity of the enzyme 
alanine amino transferase (ALT) (also known as a serum glutamic pyruvic 
transaminase or SGPT) in serum and plasma. Alanine amino transferase 
measurements are used in the diagnosis and treatment of certain liver 
diseases (e.g., viral hepatitis and cirrhosis) and heart diseases.
    (b) Classification. Class I (general controls). The device is exempt 
from the premarket notification procedures in subpart E of part 807 of 
this chapter subject to Sec. 862.9.

[52 FR 16122, May 1, 1987, as amended at 65 FR 2305, Jan. 14, 2000]



Sec. 862.1035  Albumin test system.

    (a) Identification. An albumin test system is a device intended to 
measure the albumin concentration in serum and plasma. Albumin 
measurements are used in the diagnosis and treatment of numerous 
diseases involving primarily the liver or kidneys.
    (b) Classification. Class II.



Sec. 862.1040  Aldolase test system.

    (a) Identification. An aldolase test system is a device intended to 
measure the activity of the enzyme aldolase in serum or plasma. Aldolase 
measurements are used in the diagnosis and treatment of the early stages 
of acute hepatitis and for certain muscle diseases such as progressive 
Duchenne-type muscular dystrophy.
    (b) Classification. Class I (general controls). The device is exempt 
from the premarket notification procedures in subpart E of part 807 of 
this chapter subject to Sec. 862.9.

[52 FR 16122, May 1, 1987, as amended at 65 FR 2305, Jan. 14, 2000]



Sec. 862.1045  Aldosterone test system.

    (a) Identification. An aldosterone test system is a device intended 
to measure the hormone aldosterone in serum and urine. Aldosterone 
measurements are used in the diagnosis and treatment of primary 
aldosteronism (a disorder caused by the excessive secretion of 
aldosterone by the adrenal gland), hypertension caused by primary 
aldosteronism, selective hypoaldosteronism, edematous states, and other 
conditions of electrolyte imbalance.
    (b) Classification. Class II.



Sec. 862.1050  Alkaline phosphatase or isoenzymes test system.

    (a) Identification. An alkaline phosphatase or isoenzymes test 
system is a device intended to measure alkaline phosphatase or its 
isoenzymes (a group of enzymes with similar biological activity) in 
serum or plasma. Measurements of alkaline phosphatase or its isoenzymes 
are used in the diagnosis and treatment of liver, bone, parathyroid, and 
intestinal diseases.
    (b) Classification. Class II.



Sec. 862.1060  Delta-aminolevulinic acid test system.

    (a) Identification. A delta-aminolevulinic acid test system is a 
device intended to measure the level of delta-aminolevulinic acid (a 
precursor of porphyrin) in urine. Delta-aminolevulinic acid measurements 
are used in the diagnosis and treatment of lead poisoning and certain 
porphyrias (diseases affecting the liver, gastrointestinal, and nervous 
systems that are accompanied by increased urinary excretion of various 
heme compounds including delta-aminolevulinic acid).
    (b) Classification. Class I (general controls). The device is exempt 
from premarket notification procedures in subpart E of part 807 of this 
chapter subject to Sec. 862.9.

[52 FR 16122, May 1, 1987, as amended at 65 FR 2305, Jan. 14, 2000]



Sec. 862.1065  Ammonia test system.

    (a) Identification. An ammonia test system is a device intended to 
measure ammonia levels in blood, serum, and plasma, Ammonia measurements 
are

[[Page 178]]

used in the diagnosis and treatment of severe liver disorders, such as 
cirrhosis, hepatitis, and Reye's syndrome.
    (b) Classification. Class I.



Sec. 862.1070  Amylase test system.

    (a) Identification. An amylase test system is a device intended to 
measure the activity of the enzyme amylase in serum and urine. Amylase 
measurements are used primarily for the diagnosis and treatment of 
pancreatitis (inflammation of the pancreas).
    (b) Classification. Class II.



Sec. 862.1075  Androstenedione test system.

    (a) Identification. An androstenedione test system is a device 
intended to measure androstenedione (a substance secreted by the testes, 
ovary, and adrenal glands) in serum. Adrostenedione measurements are 
used in the diagnosis and treatment of females with excessive levels of 
androgen (male sex hormone) production.
    (b) Classification. Class I (general controls). The device is exempt 
from the premarket notification procedures in subpart E of part 807 of 
this chapter subject to Sec. 862.9.

[52 FR 16122, May 1, 1987, as amended at 65 FR 2305, Jan. 14, 2000]



Sec. 862.1080  Androsterone test system.

    (a) Identification. An androsterone test system is a device intended 
to measure the hormone adrosterone in serum, plasma, and urine. 
Androsterone measurements are used in the diagnosis and treatment of 
gonadal and adrenal diseases.
    (b) Classification. Class I (general controls). The device is exempt 
from the premarket notification procedures in subpart E of part 807 of 
this chapter subject to Sec. 862.9.

[52 FR 16122, May 1, 1987, as amended at 65 FR 2305, Jan. 14, 2000]



Sec. 862.1085  Angiotensin I and renin test system.

    (a) Identification. An angiotensin I and renin test system is a 
device intended to measure the level of angiotensin I generated by renin 
in plasma. Angiotensin I measurements are used in the diagnosis and 
treatment of certain types of hypertension.
    (b) Classification. Class II.



Sec. 862.1090  Angiotensin converting enzyme (A.C.E.) test system.

    (a) Identification. An angiotensin converting enzyme (A.C.E.) test 
system is a device intended to measure the activity of angiotensin 
converting enzyme in serum and plasma. Measurements obtained by this 
device are used in the diagnosis and treatment of diseases such as 
sarcoidosis, a disease characterized by the formation of nodules in the 
lungs, bones, and skin, and Gaucher's disease, a hereditary disorder 
affecting the spleen.
    (b) Classification. Class II.



Sec. 862.1095  Ascorbic acid test system.

    (a) Identification. An ascorbic acid test system is a device 
intended to measure the level of ascorbic acid (vitamin C) in plasma, 
serum, and urine. Ascorbic acid measurements are used in the diagnosis 
and treatment of ascorbic acid dietary deficiencies.
    (b) Classification. Class I (general controls). The device is exempt 
from the premarket notification procedures in subpart E of part 807 of 
this chapter subject to Sec. 862.9.

[52 FR 16122, May 1, 1987, as amended at 65 FR 2305, Jan. 14, 2000]



Sec. 862.1100  Aspartate amino transferase (AST/SGOT) test system.

    (a) Identification. An aspartate amino transferase (AST/SGOT) test 
system is a device intended to measure the activity of the enzyme 
aspartate amino transferase (AST) (also known as a serum glutamic 
oxaloacetic transferase or SGOT) in serum and plasma. Aspartate amino 
transferase measurements are used in the diagnosis and treatment of 
certain types of liver and heart disease.
    (b) Classification. Class II.



Sec. 862.1110  Bilirubin (total or direct) test system.

    (a) Identification. A bilirubin (total or direct) test system is a 
device intended to measure the levels of bilirubin (total

[[Page 179]]

or direct) in plasma or serum. Measurements of the levels of bilirubin, 
an organic compound formed during the normal and abnormal distruction of 
red blood cells, if used in the diagnosis and treatment of liver, 
hemolytic hematological, and metabolic disorders, including hepatitis 
and gall bladder block.
    (b) Classification. Class II.



Sec. 862.1113  Bilirubin (total and unbound) in the neonate test system.

    (a) Identification. A bilirubin (total and unbound) in the neonate 
test system is a device intended to measure the levels of bilirubin 
(total and unbound) in the blood (serum) of newborn infants to aid in 
indicating the risk of bilirubin encephalopathy (kernicterus).
    (b) Classification. Class I.

[54 FR 30206, July 19, 1989]



Sec. 862.1115  Urinary bilirubin and its conjugates (nonquantitative) test system.

    (a) Identification. A urinary bilirubin and its conjugates 
(nonquantitative) test system is a device intended to measure the levels 
of bilirubin conjugates in urine. Measurements of urinary bilirubin and 
its conjugates (nonquantitative) are used in the diagnosis and treatment 
of certain liver diseases.
    (b) Classification. Class I (general controls). The device is exempt 
from the premarket notification procedures in subpart E of part 807 of 
this chapter subject to Sec. 862.9.

[52 FR 16122, May 1, 1987, as amended at 65 FR 2305, Jan. 14, 2000]



Sec. 862.1118  Biotinidase test system.

    (a) Identification. The biotinidase test system is an in vitro 
diagnostic device intended to measure the activity of the enzyme 
biotinidase in blood. Measurements of biotinidase are used in the 
treatment and diagnosis of biotinidase deficiency, an inborn error of 
metabolism in infants, characterized by the inability to utilize dietary 
protein bound vitamin or to recycle endogenous biotin. The deficiency 
may result in irreversible neurological impairment.
    (b) Classification. Class II (special controls). The special control 
is sale, distribution, and use in accordance with the prescription 
device requirements in Sec. 801.109 of this chapter.

[65 FR 16521, Mar. 29, 2000]

    Effective Date Note: At 65 FR 16521, Mar. 29, 2000, Sec. 862.1118 
was added, effective Apr. 28, 2000.



Sec. 862.1120  Blood gases (PCO2, PO2) and blood pH test system.

    (a) Identification. A blood gases (PCO2, PO2) 
and blood pH test system is a device intended to measure certain gases 
in blood, serum, plasma or pH of blood, serum, and plasma. Measurements 
of blood gases (PCO2, PO2) and blood pH are used 
in the diagnosis and treatment of life-threatening acid-base 
disturbances.
    (b) Classification. Class II.



Sec. 862.1130  Blood volume test system.

    (a) Identification. A blood volume test system is a device intended 
to measure the circulating blood volume. Blood volume measurements are 
used in the diagnosis and treatment of shock, hemorrhage, and 
polycythemia vera (a disease characterized by an absolute increase in 
erythrocyte mass and total blood volume).
    (b) Classification. Class I (general controls). The device is exempt 
from the premarket notification procedures in subpart E of part 807 of 
this chapter subject to Sec. 862.9.

[52 FR 16122, May 1, 1987, as amended at 65 FR 2305, Jan. 14, 2000]



Sec. 862.1135  C-peptides of proinsulin test system.

    (a) Identification. A C-peptides of proinsulin test system is a 
device intended to measure C-peptides of proinsulin levels in serum, 
plasma, and urine. Measurements of C-peptides of proinsulin are used in 
the diagnosis and treatment of patients with abnormal insulin secretion, 
including diabetes mellitus.
    (b) Classification. Class I (general controls). The device is exempt 
from the premarket notification procedures in subpart E of part 807 of 
this chapter subject to Sec. 862.9.

[52 FR 16122, May 1, 1987, as amended at 65 FR 2305, Jan. 14, 2000]

[[Page 180]]



Sec. 862.1140  Calcitonin test system.

    (a) Identification. A calcitonin test system is a device intended to 
measure the thyroid hormone calcitonin (thyrocalcitonin) levels in 
plasma and serum. Calcitonin measurements are used in the diagnosis and 
treatment of diseases involving the thyroid and parathyroid glands, 
including carcinoma and hyperparathyroidism (excessive activity of the 
parathyroid gland).
    (b) Classification. Class II.



Sec. 862.1145  Calcium test system.

    (a) Identification. A calcium test system is a device intended to 
measure the total calcium level in serum. Calcium measurements are used 
in the diagnosis and treatment of parathyroid disease, a variety of bone 
diseases, chronic renal disease and tetany (intermittent muscular 
contractions or spasms).
    (b) Classification. Class II.



Sec. 862.1150  Calibrator.

    (a) Identification. A calibrator is a device intended for medical 
purposes for use in a test system to establish points of reference that 
are used in the determination of values in the measurement of substances 
in human specimens. (See also Sec. 862.2 in this part.)
    (b) Classification. Class II.



Sec. 862.1155  Human chorionic gonadotropin (HCG) test system.

    (a) Human chorionic gonadotropin (HCG) test system intended for the 
early detection of pregnancy--(1) Identification. A human chorionic 
gonadotropin (HCG) test system is a device intended for the early 
detection of pregnancy is intended to measure HCG, a placental hormone, 
in plasma or urine.
    (2) Classification. Class II.
    (b) Human chorionic gonadotropin (HCG) test system intended for any 
uses other than early detection of pregnancy--(1) Identification. A 
human chorionic goadotropin (HCG) test system is a device intended for 
any uses other than early detection of pregnancy (such as an aid in the 
diagnosis, prognosis, and management of treatment of persons with 
certain tumors or carcinomas) is intended to measure HCG, a placental 
hormone, in plasma or urine.
    (2) Classification. Class III.
    (3) Date PMA or notice of completion of a PDP is required. As of the 
enactment date of the amendments, May 28, 1976, an approval under 
section 515 of the act is required before the device described in 
paragraph (b)(1) may be commercially distributed. See Sec. 862.3.



Sec. 862.1160  Bicarbonate/carbon dioxide test system.

    (a) Identification. A bicarbonate/carbon dioxide test system is a 
device intended to measure bicarbonate/carbon dioxide in plasma, serum, 
and whole blood. Bicarbonate/carbon dioxide measurements are used in the 
diagnosis and treatment of numerous potentially serious disorders 
associated with changes in body acid-base balance.
    (b) Classification. Class II.



Sec. 862.1165  Catecholamines (total) test system.

    (a) Identification. A catecholamines (total) test system is a device 
intended to determine whether a group of similar compounds (epinephrine, 
norepinephrine, and dopamine) are present in urine and plasma. 
Catecholamine determinations are used in the diagnosis and treatment of 
adrenal medulla and hypertensive disorders, and for catecholamine-
secreting tumors (pheochromo-cytoma, neuroblastoma, ganglioneuroma, and 
retinoblastoma).
    (b) Classification. Class I (general controls). The device is exempt 
from the premarket notification procedures in subpart E of part 807 of 
this chapter subject to Sec. 862.9.

[52 FR 16122, May 1, 1987, as amended at 65 FR 2305, Jan. 14, 2000]



Sec. 862.1170  Chloride test system.

    (a) Identification. A chloride test system is a device intended to 
measure the level of chloride in plasma, serum, sweat, and urine. 
Chloride measurements are used in the diagnosis and treatment of 
electrolyte and metabolic disorders such as cystic fibrosis and diabetic 
acidosis.
    (b) Classification. Class II.

[[Page 181]]



Sec. 862.1175  Cholesterol (total) test system.

    (a) Identification. A cholesterol (total) test system is a device 
intended to measure cholesterol in plasma and serum. Cholesterol 
measurements are used in the diagnosis and treatment of disorders 
involving excess cholesterol in the blood and lipid and lipoprotein 
metabolism disorders.
    (b) Classification. Class I (general controls). The device is exempt 
from the premarket notification procedures in subpart E of part 807 of 
this chapter subject to Sec. 862.9.

[52 FR 16122, May 1, 1987, as amended at 65 FR 2305, Jan. 14, 2000]



Sec. 862.1177  Cholylglycine test system.

    (a) Identification. A cholylglycine test system is a device intended 
to measure the bile acid cholylglycine in serum. Measurements obtained 
by this device are used in the diagnosis and treatment of liver 
disorders, such as cirrhosis or obstructive liver disease.
    (b) Classification. Class II.



Sec. 862.1180  Chymotrypsin test system.

    (a) Identification. A chymotrypsin test system is a device intended 
to measure the activity of the enzyme chymotrypsin in blood and other 
body fluids and in feces. Chymotrypsin measurements are used in the 
diagnosis and treatment of pancreatic exocrine insufficiency.
    (b) Classification. Class I (general controls). The device is exempt 
from the premarket notification procedures in subpart E of part 807 of 
this chapter subject to Sec. 862.9.

[52 FR 16122, May 1, 1987, as amended at 65 FR 2305, Jan. 14, 2000]



Sec. 862.1185  Compound S (11-deoxycortisol) test system.

    (a) Identification. A compound S (11-dioxycortisol) test system is a 
device intended to measure the level of compound S (11-dioxycortisol) in 
plasma. Compound S is a steroid intermediate in the biosynthesis of the 
adrenal hormone cortisol. Measurements of compound S are used in the 
diagnosis and treatment of certain adrenal and pituitary gland disorders 
resulting in clinical symptoms of masculinization and hypertension.
    (b) Classification. Class I (general controls). The device is exempt 
from the premarket notification procedures in subpart E of part 807 of 
this chapter subject to Sec. 862.9.

[52 FR 16122, May 1, 1987, as amended at 65 FR 2305, Jan. 14, 2000]



Sec. 862.1187  Conjugated sulfolithocholic acid (SLCG) test system.

    (a) Identification. A conjugated sulfolithocholic acid (SLCG) test 
system is a device intended to measure the bile acid SLCG in serum. 
Measurements obtained by this device are used in the diagnosis and 
treatment of liver disorders, such as cirrhosis or obstructive liver 
disease.
    (b) Classification. Class II.



Sec. 862.1190  Copper test system.

    (a) Identification. A copper test system is a device intended to 
measure copper levels in plasma, serum, and urine. Measurements of 
copper are used in the diagnosis and treatment of anemia, infections, 
inflammations, and Wilson's disease (a hereditary disease primarily of 
the liver and nervous system). Test results are also used in monitoring 
patients with Hodgkin's disease (a disease primarily of the lymph 
system).
    (b) Classification. Class I. The device is exempt from the premarket 
notification procedures in subpart E of part 807.

[52 FR 16122, May 1, 1987, as amended at 53 FR 21449, June 8, 1988]



Sec. 862.1195  Corticoids test system.

    (a) Identification. A corticoids test system is a device intended to 
measure the levels of corticoids (hormones of the adrenal cortex) in 
serum and p lasma. Measurements of corticoids are used in the diagnosis 
and treatment of disorders of the cortex of the adrenal glands, 
especially those associated with hypertension and electrolyte 
disturbances.
    (b) Classification. Class I (general controls). The device is exempt 
from the premarket notification procedures in

[[Page 182]]

subpart E of part 807 of this chapter subject to Sec. 862.9.

[52 FR 16122, May 1, 1987, as amended at 65 FR 2305, Jan. 14, 2000]



Sec. 862.1200  Corticosterone test system.

    (a) Identification. A corticosterone test system is a device 
intended to measure corticosterone (a steroid secreted by the adrenal 
gland) levels in plasma. Measurements of corticosterone are used in the 
diagnosis and treatment of adrenal disorders such as adrenal cortex 
disorders and blocks in cortisol synthesis.
    (b) Classification. Class I (general controls). The device is exempt 
from the premarket notification procedures in subpart E of part 807 of 
this chapter subject to Sec. 862.9.

[52 FR 16122, May 1, 1987, as amended at 65 FR 2305, Jan. 14, 2000]



Sec. 862.1205  Cortisol (hydrocortisone and hydroxycorticosterone) test system.

    (a) Identification. A cortisol (hydrocortisone and 
hydroxycorticosterone) test system is a device intended to measure the 
cortisol hormones secreted by the adrenal gland in plasma and urine. 
Measurements of cortisol are used in the diagnosis and treatment of 
disorders of the adrenal gland.
    (b) Classification. Class II.



Sec. 862.1210  Creatine test system.

    (a) Identification. A creatine test system is a device intended to 
measure creatine (a substance synthesized in the liver and pancreas and 
found in biological fluids) in plasma, serum, and urine. Measurements of 
creatine are used in the diagnosis and treatment of muscle diseases and 
endocrine disorders including hyperthyroidism.
    (b) Classification. Class I. The device is exempt from the premarket 
notification procedures in subpart E of part 807.

[52 FR 16122, May 1, 1987, as amended at 53 FR 21449, June 8, 1988]



Sec. 862.1215  Creatine phosphokinase/creatine kinase or isoenzymes test system.

    (a) Identification. A creatine phosphokinase/creatine kinase or 
isoenzymes test system is a device intended to measure the activity of 
the enzyme creatine phosphokinase or its isoenzymes (a group of enzymes 
with similar biological activity) in plasma and serum. Measurements of 
creatine phosphokinase and its isoenzymes are used in the diagnosis and 
treatment of myocardial infarction and muscle diseases such as 
progressive, Duchenne-type muscular dystrophy.
    (b) Classification. Class II.



Sec. 862.1225  Creatinine test system.

    (a) Identification. A creatinine test system is a device intended to 
measure creatinine levels in plasma and urine. Creatinine measurements 
are used in the diagnosis and treatment of renal diseases, in monitoring 
renal dialysis, and as a calculation basis for measuring other urine 
analytes.
    (b) Classification. Class II.



Sec. 862.1230  Cyclic AMP test system.

    (a) Identification. A cyclic AMP test system is a device intended to 
measure the level of adenosine 3', 5'-monophosphate (cyclic AMP) in 
plasma, urine, and other body fluids. Cyclic AMP measurements are used 
in the diagnosis and treatment of endocrine disorders, including 
hyperparathyroidism (overactivity of the parathyroid gland). Cyclic AMP 
measurements may also be used in the diagnosis and treatment of Graves' 
disease (a disorder of the thyroid) and in the differentiation of causes 
of hypercalcemia (elevated levels of serum calcium.)
    (b) Classification. Class II.



Sec. 862.1240  Cystine test system.

    (a) Identification. A cystine test system is a device intended to 
measure the amino acid cystine in urine. Cystine measurements are used 
in the diagnosis of cystinuria (occurrence of cystine in urine). 
Patients with cystinuria frequently develop kidney calculi (stones).
    (b) Classification. Class I (general controls). The device is exempt 
from the premarket notification procedures in subpart E of part 807 of 
this chapter subject to Sec. 862.9.

[52 FR 16122, May 1, 1987, as amended at 65 FR 2305, Jan. 14, 2000]

[[Page 183]]



Sec. 862.1245  Dehydroepiandrosterone (free and sulfate) test system.

    (a) Identification. A dehydroepiandrosterone (free and sulfate) test 
system is a device intended to measure dehydroepiandrosterone (DHEA) and 
its sulfate in urine, serum, plasma, and amniotic fluid. 
Dehydroepiandrosterone measurements are used in the diagnosis and 
treatment of DHEA-secreting adrenal carcinomas.
    (b) Classification. Class I (general controls). The device is exempt 
from the premarket notification procedures in subpart E of part 807 of 
this chapter subject to Sec. 862.9.

[52 FR 16122, May 1, 1987, as amended at 65 FR 2306, Jan. 14, 2000]



Sec. 862.1250  Desoxycorticosterone test system.

    (a) Identification. A desoxycorticosterone test system is a device 
intended to measure desoxycorticosterone (DOC) in plasma and urine. DOC 
measurements are used in the diagnosis and treatment of patients with 
hypermineralocorticoidism (excess retention of sodium and loss of 
potassium) and other disorders of the adrenal gland.
    (b) Classification. Class I (general controls). The device is exempt 
from the premarket notification procedures in subpart E of part 807 of 
this chapter subject to Sec. 862.9.

[52 FR 16122, May 1, 1987, as amended at 65 FR 2306, Jan. 14, 2000]



Sec. 862.1255  2,3-Diphosphoglyceric acid test system.

    (a) Identification. A 2,3-diphosphoglyceric acid test system is a 
device intended to measure 2,3-diphosphoglyceric acid (2,3-DPG) in 
erythrocytes (red blood cells). Measurements of 2,3-diphosphoglyceric 
acid are used in the diagnosis and treatment of blood disorders that 
affect the delivery of oxygen by erythrocytes to tissues and in 
monitoring the quality of stored blood.
    (b) Classification. Class I. The device is exempt from the premarket 
notification procedures in subpart E of part 807.

[52 FR 16122, May 1, 1987, as amended at 53 FR 21449, June 8, 1988]



Sec. 862.1260  Estradiol test system.

    (a) Identification. An estradiol test system is a device intended to 
measure estradiol, an estrogenic steroid, in plasma. Estradiol 
measurements are used in the diagnosis and treatment of various hormonal 
sexual disorders and in assessing placental function in complicated 
pregnancy.
    (b) Classification. Class I (general controls). The device is exempt 
from the premarket notification procedures in subpart E of part 807 of 
this chapter subject to Sec. 862.9.

[52 FR 16122, May 1, 1987, as amended at 65 FR 2306, Jan. 14, 2000]



Sec. 862.1265  Estriol test system.

    (a) Identification. An estriol test system is a device intended to 
measure estriol, an estrogenic steroid, in plasma, serum, and urine of 
pregnant females. Estriol measurements are used in the diagnosis and 
treatment of fetoplacental distress in certain cases of high-risk 
pregnancy.
    (b) Classification. Class I (general controls). The device is exempt 
from the premarket notification procedures in subpart E of part 807 of 
this chapter subject to Sec. 862.9.

[52 FR 16122, May 1, 1987, as amended at 65 FR 2306, Jan. 14, 2000]



Sec. 862.1270  Estrogens (total, in pregnancy) test system.

    (a) Identification. As estrogens (total, in pregnancy) test system 
is a device intended to measure total estrogens in plasma, serum, and 
urine during pregnancy. The device primarily measures estrone plus 
estradiol. Measurements of total estrogens are used to aid in the 
diagnosis and treatment of fetoplacental distress in certain cases of 
high-risk pregnancy.
    (b) Classification. Class I (general controls). The device is exempt 
from the premarket notification procedures in subpart E of part 807 of 
this chapter subject to Sec. 862.9.

[52 FR 16122, May 1, 1987, as amended at 65 FR 2306, Jan. 14, 2000]

[[Page 184]]



Sec. 862.1275  Estrogens (total, nonpregnancy) test system.

    (a) Identification. As estrogens (total, nonpregnancy) test system 
is a device intended to measure the level of estrogens (total estrone, 
estradiol, and estriol) in plasma, serum, and urine of males and 
nonpregnant females. Measurement of estrogens (total, nonpregnancy) is 
used in the diagnosis and treatment of numerous disorders, including 
infertility, amenorrhea (absence of menses) differentiation of primary 
and secondary ovarian malfunction, estrogen secreting testicular and 
ovarian tumors, and precocious puberty in females.
    (b) Classification. Class I (general controls). The device is exempt 
from the premarket notification procedures in subpart E of part 807 of 
this chapter subject to Sec. 862.9.

[52 FR 16122, May 1, 1987, as amended at 65 FR 2306, Jan. 14, 2000]



Sec. 862.1280  Estrone test system.

    (a) Identification. An estrone test system is a device intended to 
measure estrone, an estrogenic steroid, in plasma. Estrone measurements 
are used in the diagnosis and treatment of numerous disorders, including 
infertility, amenorrhea, differentiation of primary and secondary 
ovarian malfunction, estrogen secreting testicular and ovarian tumors, 
and precocious puberty in females.
    (b) Classification. Class I (general controls). The device is exempt 
from the premarket notification procedures in subpart E of part 807 of 
this chapter subject to Sec. 862.9.

[52 FR 16122, May 1, 1987, as amended at 65 FR 2306, Jan. 14, 2000]



Sec. 862.1285  Etiocholanolone test system.

    (a) Identification. An etiocholanolone test system is a device 
intended to measure etiocholanolone in serum and urine. Etiocholanolone 
is a metabolic product of the hormone testosterone and is excreted in 
the urine. Etiocholanolone measurements are used in the diagnosis and 
treatment of disorders of the testes and ovaries.
    (b) Classification. Class I (general controls). The device is exempt 
from the premarket notification procedures in subpart E of part 807 of 
this chapter subject to Sec. 862.9.

[52 FR 16122, May 1, 1987, as amended at 65 FR 2306, Jan. 14, 2000]



Sec. 862.1290  Fatty acids test system.

    (a) Identification. A fatty acids test system is a device intended 
to measure fatty acids in plasma and serum. Measurements of fatty acids 
are used in the diagnosis and treatment of various disorders of lipid 
metabolism.
    (b) Classification. Class I. The device is exempt from the premarket 
notification procedures in subpart E of part 807.

[52 FR 16122, May 1, 1987, as amended at 53 FR 21449, June 8, 1988]



Sec. 862.1295  Folic acid test system.

    (a) Identification. A folic acid test system is a device intended to 
measure the vitamin folic acid in plasma and serum. Folic acid 
measurements are used in the diagnosis and treatment of megaloblastic 
anemia, which is characterized by the presence of megaloblasts (an 
abnormal red blood cell series) in the bone marrow.
    (b) Classification. Class II.

[52 FR 16122, May 1, 1987; 53 FR 11645, Apr. 8, 1988]



Sec. 862.1300  Follicle-stimulating hormone test system.

    (a) Identification. A follicle-stimulating hormone test system is a 
device intended to measure follicle-stimulating hormone (FSH) in plasma, 
serum, and urine. FSH measurements are used in the diagnosis and 
treatment of pituitary gland and gonadal disorders.
    (b) Classification. Class I (general controls). The device is exempt 
from the premarket notification procedures in subpart E of part 807 of 
this chapter subject to Sec. 862.9.

[52 FR 16122, May 1, 1987, as amended at 65 FR 2306, Jan. 14, 2000]



Sec. 862.1305  Formiminoglutamic acid (FIGLU) test system.

    (a) Identification. A formiminoglutamic acid (FIGLU) test system is 
a device intended to measure formiminolutamic acid in urine. FIGLU 
measurements obtained by this

[[Page 185]]

device are used in the diagnosis of anemias, such as pernicious anemia 
and congenital hemolytic anemia.
    (b) Classification. Class I. The device is exempt from the premarket 
notification procedures in subpart E of part 807.

[52 FR 16122, May 1, 1987, as amended at 53 FR 21449, June 8, 1988]



Sec. 862.1310  Galactose test system.

    (a) Identification. A galactose test system is a device intended to 
measure galactose in blood and urine. Galactose measurements are used in 
the diagnosis and treatment of the hereditary disease galactosemia (a 
disorder of galactose metabolism) in infants.
    (b) Classification. Class I.



Sec. 862.1315  Galactose-1-phosphate uridyl transferase test system.

    (a) Identification. A galactose-1-phosphate uridyl transferase test 
system is a device intended to measure the activity of the enzyme 
galactose-1-phosphate uridyl transferase in erythrocytes (red blood 
cells). Measurements of galactose-1-phosphate uridyl transferase are 
used in the diagnosis and treatment of the hereditary disease 
galactosemia (disorder of galactose metabolism) in infants.
    (b) Classification. Class II.



Sec. 862.1320  Gastric acidity test system.

    (a) Identification. A gastric acidity test system is a device 
intended to measure the acidity of gastric fluid. Measurements of 
gastric acidity are used in the diagnosis and treatment of patients with 
peptic ulcer, Zollinger-Ellison syndrome (peptic ulcer due to gastrin-
secreting tumor of the pancreas), and related gastric disorders.
    (b) Classification. Class I. The device is exempt from the premarket 
notification procedures in subpart E of part 807.

[52 FR 16122, May 1, 1987, as amended at 53 FR 21449, June 8, 1988]



Sec. 862.1325  Gastrin test system.

    (a) Identification. A gastrin test system is a device intended to 
measure the hormone gastrin in plasma and serum. Measurements of gastrin 
are used in the diagnosis and treatment of patients with ulcers, 
pernicious anemia, and the Zollinger-Ellison syndrome (peptic ulcer due 
to a gastrin-secreting tumor of the pancreas).
    (b) Classification. Class I (general controls). The device is exempt 
from the premarket notification procedures in subpart E of part 807 of 
this chapter subject to Sec. 862.9.

[52 FR 16122, May 1, 1987, as amended at 65 FR 2306, Jan. 14, 2000]



Sec. 862.1330  Globulin test system.

    (a) Identification. A globulin test system is a device intended to 
measure globulins (proteins) in plasma and serum. Measurements of 
globulin are used in the diagnosis and treatment of patients with 
numerous illnesses including severe liver and renal disease, multiple 
myeloma, and other disorders of blood globulins.
    (b) Classification. Class I (general controls). The device is exempt 
from the premarket notification procedures in subpart E of part 807 of 
this chapter subject to Sec. 862.9.

[52 FR 16122, May 1, 1987, as amended at 65 FR 2306, Jan. 14, 2000]



Sec. 862.1335  Glucagon test system.

    (a) Identification. A glucagon test system is a device intended to 
measure the pancreatic hormone glucagon in plasma and serum. Glucagon 
measurements are used in the diagnosis and treatment of patients with 
various disorders of carbohydrate metabolism, including diabetes 
mellitus, hypoglycemia, and hyperglycemia.
    (b) Classification. Class I (general controls). The device is exempt 
from the premarket notification procedures in subpart E of part 807 of 
this chapter subject to Sec. 862.9.

[52 FR 16122, May 1, 1987, as amended at 65 FR 2306, Jan. 14, 2000]



Sec. 862.1340  Urinary glucose (nonquantitative) test system.

    (a) Identification. A urinary glucose (nonquantitative) test system 
is a device intended to measure glucosuria (glucose in urine). Urinary 
glucose (nonquantitative) measurements are used in the diagnosis and 
treatment of

[[Page 186]]

carbohydrate metabolism disorders including diabetes mellitus, 
hypoglycemia, and hyperglycemia.
    (b) Classification. Class II.



Sec. 862.1345  Glucose test system.

    (a) Identification. A glucose test system is a device intended to 
measure glucose quantitatively in blood and other body fluids. Glucose 
measurements are used in the diagnosis and treatment of carbohydrate 
metabolism disorders including diabetes mellitus, neonatal hypoglycemia, 
and idiopathic hypoglycemia, and of pancreatic islet cell carcinoma.
    (b) Classification. Class II.



Sec. 862.1360  Gamma-glutamyl transpeptidase and isoenzymes test system.

    (a) Identification. A gamma-glutamyl transpeptidase and isoenzymes 
test system is a device intended to measure the activity of the enzyme 
gamma-glutamyl transpeptidase (GGTP) in plasma and serum. Gamma-glutamyl 
transpeptidase and isoenzymes measurements are used in the diagnosis and 
treatment of liver diseases such as alcoholic cirrhosis and primary and 
secondary liver tumors.
    (b) Classification. Class I (general controls). The device is exempt 
from the premarket notification procedures in subpart E of part 807 of 
this chapter subject to Sec. 862.9.

[52 FR 16122, May 1, 1987, as amended at 65 FR 2306, Jan. 14, 2000]



Sec. 862.1365  Glutathione test system.

    (a) Identification. A glutathione test system is a device intended 
to measure glutathione (the tripeptide of glycine, cysteine, and 
glutamic acid) in erythrocytes (red blood cells). Glutathione 
measurements are used in the diagnosis and treatment of certain drug-
induced hemolytic (erythrocyte destroying) anemias due to an inherited 
enzyme deficiency.
    (b) Classification. Class I. The device is exempt from the premarket 
notification procedures in subpart E of part 807.

[52 FR 16122, May 1, 1987, as amended at 53 FR 21449, June 8, 1988]



Sec. 862.1370  Human growth hormone test system.

    (a) Identification. A human growth hormone test system is a device 
intended to measure the levels of human growth hormone in plasma. Human 
growth hormone measurements are used in the diagnosis and treatment of 
disorders involving the anterior lobe of the pituitary gland.
    (b) Classification. Class I (general controls). The device is exempt 
from the premarket notification procedures in subpart E of part 807 of 
this chapter subject to Sec. 862.9.

[52 FR 16122, May 1, 1987, as amended at 65 FR 2306, Jan. 14, 2000]



Sec. 862.1375  Histidine test system.

    (a) Identification. A histidine test system is a device intended to 
measure free histidine (an amino acid) in plasma and urine. Histidine 
measurements are used in the diagnosis and treatment of hereditary 
histidinemia characterized by excess histidine in the blood and urine 
often resulting in mental retardation and disordered speech development.
    (b) Classification. Class I (general controls). The device is exempt 
from the premarket notification procedures in subpart E of part 807 of 
this chapter subject to Sec. 862.9.

[52 FR 16122, May 1, 1987, as amended at 65 FR 2306, Jan. 14, 2000]



Sec. 862.1377  Urinary homocystine (nonquantitative) test system.

    (a) Identification. A urinary homocystine (nonquantitative) test 
system is a device intended to identify homocystine (an analogue of the 
amino acid cystine) in urine. The identification of urinary homocystine 
is used in the diagnosis and treatment of homocystinuria (homosystine in 
urine), a heritable metabolic disorder which may cause mental 
retardation.
    (b) Classification. Class II.



Sec. 862.1380  Hydroxybutyric dehydrogenase test system.

    (a) Identification. A hydroxybutyric dehydrogenase test system is a 
device intended to measure the activity of the enzyme alpha-
hydroxybutric dehydrogenase (HBD) in plasma or serum. HBD

[[Page 187]]

measurements are used in the diagnosis and treatment of myocardial 
infarction, renal damage (such as rejection of transplants), certain 
hematological diseases (such as acute leukemias and megaloblastic 
anemias) and, to a lesser degree, liver disease.
    (b) Classification. Class I. The device is exempt from the premarket 
notification procedures in subpart E of part 807.

[52 FR 16122, May 1, 1987, as amended at 53 FR 21449, June 8, 1988]



Sec. 862.1385  17-Hydroxycorticosteroids (17-ketogenic steroids) test system.

    (a) Identification. A 17-hydroxycorticosteroids (17-ketogenic 
steroids) test system is a device intended to measure corticosteroids 
that possess a dihydroxyacetone
[GRAPHIC] [TIFF OMITTED] TR01FE93.028


moiety on the steroid nucleus in urine. Corticosteroids with this 
chemical configuration include cortisol, cortisone 11-desoxycortisol, 
desoxycorticosterone, and their tetrahydroderivatives. This group of 
hormones is synthesized by the adrenal gland. Measurements of 17-
hydroxycorticosteroids (17-ketogenic steroids) are used in the diagnosis 
and treatment of various diseases of the adrenal or pituitary glands and 
gonadal disorders.
    (b) Classification. Class I (general controls). The device is exempt 
from the premarket notification procedures in subpart E of part 807 of 
this chapter subject to Sec. 862.9.

[52 FR 16122, May. 1, 1987; 52 FR 29468, Aug. 7, 1987, as amended at 65 
FR 2306, Jan. 14, 2000]



Sec. 862.1390  5-Hydroxyindole acetic acid/serotonin test system.

    (a) Identification. A 5-hydroxyindole acetic acid/serotonin test 
system is a device intended to measure 5-hydroxyindole acetic acid/
serotonin in urine. Measurements of 5-hydroxyindole acetic acid/
serotonin are used in the diagnosis and treatment of carcinoid tumors of 
endocrine tissue.
    (b) Classification. Class I (general controls). The device is exempt 
from the premarket notification procedures in subpart E of part 807 of 
this chapter subject to Sec. 862.9.

[52 FR 16122, May 1, 1987, as amended at 65 FR 2306, Jan. 14, 2000]



Sec. 862.1395  17-Hydroxyprogesterone test system.

    (a) Identification. A 17-hydroxyprogesterone test system is a device 
intended to measure 17-hydroxyprogesterone (a steroid) in plasma and 
serum. Measurements of 17-hydroxyprogesterone are used in the diagnosis 
and treatment of various disorders of the adrenal glands or the ovaries.
    (b) Classification. Class I (general controls). The device is exempt 
from the premarket notification procedures in subpart E of part 807 of 
this chapter subject to Sec. 862.9.

[52 FR 16122, May 1, 1987, as amended at 65 FR 2306, Jan. 14, 2000]



Sec. 862.1400  Hydroxyproline test system.

    (a) Identification. A hydroxyproline test system is a device 
intended to measure the amino acid hydroxyproline in urine. 
Hydroxyproline measurements are used in the diagnosis and treatment of 
various collagen (connective tissue) diseases, bone disease such as 
Paget's disease, and endocrine disorders such as hyperparathyroidism and 
hyperthyroidism.
    (b) Classification. Class I (general controls). The device is exempt 
from the premarket notification procedures in subpart E of part 807 of 
this chapter subject to Sec. 862.9.

[52 FR 16122, May 1, 1987, as amended at 65 FR 2306, Jan. 14, 2000]



Sec. 862.1405  Immunoreactive insulin test system.

    (a) Identification. An immunoreactive insulin test system is a 
device intended to measure immunoreactive insulin in serum and plasma. 
Immunoreactive insulin measurements are used in the diagnosis and 
treatment of various carbohydrate metabolism disorders, including 
diabetes mellitus, and hypoglycemia.
     (b) Classification. Class I (general controls). The device is 
exempt from the

[[Page 188]]

premarket notification procedures in subpart E of part 807 of this 
chapter subject to Sec. 862.9.

[52 FR 16122, May 1, 1987, as amended at 65 FR 2306, Jan. 14, 2000]



Sec. 862.1410  Iron (non-heme) test system.

    (a) Identification. An iron (non-heme) test system is a device 
intended to measure iron (non-heme) in serum and plasma. Iron (non-heme) 
measurements are used in the diagnosis and treatment of diseases such as 
iron deficiency anemia, hemochromatosis (a disease associated with 
widespread deposit in the tissues of two iron-containing pigments, 
hemosiderin and hemofuscin, and characterized by pigmentation of the 
skin), and chronic renal disease.
    (b) Classification. Class I.



Sec. 862.1415  Iron-binding capacity test system.

    (a) Identification. An iron-binding capacity test system is a device 
intended to measure iron-binding capacity in serum. Iron-binding 
capacity measurements are used in the diagnosis and treatment of anemia.
    (b) Classification. Class I.



Sec. 862.1420  Isocitric dehydrogenase test system.

    (a) Identification. An isocitric dehydrogenase test system is a 
device intended to measure the activity of the enzyme isocitric 
dehydrogenase in serum and plasma. Isocitric dehydrogenase measurements 
are used in the diagnosis and treatment of liver disease such as viral 
hepatitis, cirrhosis, or acute inflammation of the biliary tract; 
pulmonary disease such as pulmonary infarction (local arrest or sudden 
insufficiency of the blood supply to the lungs), and diseases associated 
with pregnancy.
    (b) Classification. Class I. The device is exempt from the premarket 
notification procedures in subpart E of part 807.

[52 FR 16122, May 1, 1987, as amended at 53 FR 21449, June 8, 1988]



Sec. 862.1430  17-Ketosteroids test system.

    (a) Identification. A 17-ketosteroids test system is a device 
intended to measure 17-ketosteroids in urine. Measurements of 17-
ketosteroids are used in the diagnosis and treatment of disorders of the 
adrenal cortex and gonads and of other endocrine disorders, including 
hypertension, diabetes, and hypothyroidism.
     (b) Classification. Class I (general controls). The device is 
exempt from the premarket notification procedures in subpart E of part 
807 of this chapter subject to Sec. 862.9.

[52 FR 16122, May 1, 1987, as amended at 65 FR 2307, Jan. 14, 2000]



Sec. 862.1435  Ketones (nonquantitative) test system.

    (a) Identification. A ketones (nonquantitative) test system is a 
device intended to identify ketones in urine and other body fluids. 
Identification of ketones is used in the diagnosis and treatment of 
acidosis (a condition characterized by abnormally high acidity of body 
fluids) or ketosis (a condition characterized by increased production of 
ketone bodies such as acetone) and for monitoring patients on ketogenic 
diets and patients with diabetes.
    (b) Classification. Class I (general controls). The device is exempt 
from the premarket notification procedures in subpart E of part 807 of 
this chapter subject to Sec. 862.9.

[52 FR 16122, May 1, 1987, as amended at 65 FR 2307, Jan. 14, 2000]



Sec. 862.1440  Lactate dehydrogenase test system.

    (a) Identification. A lactate dehydrogenase test system is a device 
intended to measure the activity of the enzyme lactate dehydrogenase in 
serum. Lactate dehydrogenase measurements are used in the diagnosis and 
treatment of liver diseases such as acute viral hepatitis, cirrhosis, 
and metastatic carcinoma of the liver, cardiac diseases such as 
myocardial infarction, and tumors of the lung or kidneys.
    (b) Classification. Class II (special controls). The device is 
exempt from the premarket notification procedures in subpart E of part 
807 of this chapter subject to Sec. 862.9.

[52 FR 16122, May 1, 1987, as amended at 63 FR 59225, Nov. 3, 1998]

[[Page 189]]



Sec. 862.1445  Lactate dehydrogenase isoenzymes test system.

    (a) Identification. A lactate dehydrogenase isoenzymes test system 
is a device intended to measure the activity of lactate dehydrogenase 
isoenzymes (a group of enzymes with similar biological activity) in 
serum. Measurements of lactate dehydrogenase isoenzymes are used in the 
diagnosis and treatment of liver diseases, such as viral hepatitis, and 
myocardial infarction.
    (b) Classification. Class II.



Sec. 862.1450  Lactic acid test system.

    (a) Identification. A lactic acid test system is a device intended 
to measure lactic acid in whole blood and plasma. Lactic acid 
measurements that evaluate the acid-base status are used in the 
diagnosis and treatment of lactic acidosis (abnormally high acidity of 
the blood).
    (b) Classification. Class I (general controls). The device is exempt 
from the premarket notification procedures in subpart E of part 807 of 
this chapter subject to Sec. 862.9.

[52 FR 16122, May 1, 1987, as amended at 65 FR 2307, Jan. 14, 2000]



Sec. 862.1455  Lecithin/sphingomyelin ratio in amniotic fluid test system.

    (a) Identification. A lecithin/sphingomyelin ratio in amniotic fluid 
test system is a device intended to measure the lecithin/sphingomyelin 
ratio in amniotic fluid. Lecithin and sphingomyelin are phospholipids 
(fats or fat-like substances containing phosphorus). Measurements of the 
lecithin/sphingomyelin ratio in amniotic fluid are used in evaluating 
fetal maturity.
    (b) Classification. Class II.



Sec. 862.1460  Leucine aminopeptidase test system.

    (a) Identification. A leucine aminopeptidase test system is a device 
intended to measure the activity of the enzyme leucine amino-peptidase 
in serum, plasma, and urine. Leucine aminopeptidase measurements are 
used in the diagnosis and treatment of liver diseases such as viral 
hepatitis and obstructive jaundice.
    (b)  Classification. Class I (general controls). The device is 
exempt from the premarket notification procedures in subpart E of part 
807 of this chapter subject to Sec. 862.9.

[52 FR 16122, May 1, 1987, as amended at 65 FR 2307, Jan. 14, 2000]



Sec. 862.1465  Lipase test system.

    (a) Identification. A lipase test system is a device intended to 
measure the activity of the enzymes lipase in serum. Lipase measurements 
are used in diagnosis and treatment of diseases of the pancreas such as 
acute pancreatitis and obstruction of the pancreatic duct.
    (b) Classification. Class I (general controls). The device is exempt 
from the premarket notification procedures in subpart E of part 807 of 
this chapter subject to Sec. 862.9.

[52 FR 16122, May 1, 1987, as amended at 65 FR 2307, Jan. 14, 2000]



Sec. 862.1470  Lipid (total) test system.

    (a) Identification. A lipid (total) test system is a device intended 
to measure total lipids (fats or fat-like substances) in serum and 
plasma. Lipid (total) measurements are used in the diagnosis and 
treatment of various diseases involving lipid metabolism and 
atherosclerosis.
    (b) Classification. Class I. The device is exempt from the premarket 
notification procedures in subpart E of part 807.

[52 FR 16122, May 1, 1987, as amended at 53 FR 21449, June 8, 1988]



Sec. 862.1475  Lipoprotein test system.

    (a) Identification. A lipoprotein test system is a device intended 
to measure lipoprotein in serum and plasma. Lipoprotein measurements are 
used in the diagnosis and treatment of lipid disorders (such as diabetes 
mellitus), atherosclerosis, and various liver and renal diseases.
    (b) Classification. Class I (general controls). The device is exempt 
from the premarket notification procedures in subpart E of part 807 of 
this chapter subject to Sec. 862.9.

[52 FR 16122, May 1, 1987, as amended at 65 FR 2307, Jan. 14, 2000]

[[Page 190]]



Sec. 862.1485  Luteinizing hormone test system.

    (a) Identification. A luteinizing hormone test system is a device 
intended to measure luteinizing hormone in serum and urine. Luteinizing 
hormone measurements are used in the diagnosis and treatment of gonadal 
dysfunction.
    (b) Classification. Class I (general controls). The device is exempt 
from the premarket notification procedures in subpart E of part 807 of 
this chapter subject to Sec. 862.9.

[52 FR 16122, May 1, 1987, as amended at 65 FR 2307, Jan. 14, 2000]



Sec. 862.1490  Lysozyme (muramidase) test system.

    (a) Identification. A lysozyme (muramidase) test system is a device 
intended to measure the activity of the bacteriolytic enzyme lysozyme 
(muramidase) in serum, plasma, leukocytes, and urine. Lysozyme 
measurements are used in the diagnosis and treatment of monocytic 
leukemia and kidney disease.
    (b) Classification. Class I. The device is exempt from the premarket 
notification procedures in subpart E of part 807.

[52 FR 16122, May 1, 1987, as amended at 53 FR 21449, June 8, 1988]



Sec. 862.1495  Magnesium test system.

    (a) Identification. A magnesium test system is a device intended to 
measure magnesium levels in serum and plasma. Magnesium measurements are 
used in the diagnosis and treatment of hypomagnesemia (abnormally low 
plasma levels of magnesium) and hypermagnesemia (abnormally high plasma 
levels of magnesium).
    (b) Classification. Class I.



Sec. 862.1500  Malic dehydrogenase test system.

    (a) Identification. A malic dehydrogenase test system is a device 
that is intended to measure the activity of the enzyme malic 
dehydrogenase in serum and plasma. Malic dehydrogenase measurements are 
used in the diagnosis and treatment of muscle and liver diseases, 
myocardial infarctions, cancer, and blood disorders such as myelogenous 
(produced in the bone marrow) leukemia.
    (b)  Classification. Class I (general controls). The device is 
exempt from the premarket notification procedures in subpart E of part 
807 of this chapter subject to Sec. 862.9.

[52 FR 16122, May 1, 1987, as amended at 65 FR 2307, Jan. 14, 2000]



Sec. 862.1505  Mucopolysaccharides (nonquantitative) test system.

    (a) Identification. A mucopolysaccharides (nonquantitative) test 
system is a device intended to measure the levels of mucopolysaccharides 
in urine. Mucopolysaccharide measurements in urine are used in the 
diagnosis and treatment of various inheritable disorders that affect 
bone and connective tissues, such as Hurler's, Hunter's, Sanfilippo's, 
Scheie's Morquio's and Maroteaux-Lamy syndromes.
    (b) Classification. Class I (general controls). The device is exempt 
from the premarket notification procedures in subpart E of part 807 of 
this chapter subject to Sec. 862.9.

[52 FR 16122, May 1, 1987, as amended at 65 FR 2307, Jan. 14, 2000]



Sec. 862.1509  Methylmalonic acid (nonquantitative) test system.

    (a) Identification. A methylmalonic acid (nonquantitative) test 
system is a device intended to identify methylmalonic acid in urine. The 
identification of methylmalonic acid in urine is used in the diagnosis 
and treatment of methylmalonic aciduria, a heritable metabolic disorder 
which, if untreated, may cause mental retardation.
    (b) Classification. Class II.



Sec. 862.1510  Nitrite (nonquantitative) test system.

    (a) Identification. A nitrite (nonquantitative) test system is a 
device intended to identify nitrite in urine. Nitrite identification is 
used in the diagnosis and treatment of uninary tract infection of 
bacterial origin.
    (b) Classification. Class I (general controls). The device is exempt 
from the premarket notification procedures in

[[Page 191]]

subpart E of part 807 of this chapter subject to Sec. 862.9.

[52 FR 16122, May 1, 1987, as amended at 65 FR 2307, Jan. 14, 2000]



Sec. 862.1515  Nitrogen (amino-nitrogen) test system.

    (a) Identification. A nitrogen (amino-nitrogen) test system is a 
device intended to measure amino acid nitrogen levels in serum, plasma, 
and urine. Nitrogen (amino-nitrogen) measurements are used in the 
diagnosis and treatment of certain forms of severe liver disease and 
renal disorders.
    (b) Classification. Class I. The device is exempt from the premarket 
notification procedures in subpart E of part 807.

[52 FR 16122, May 1, 1987, as amended at 53 FR 21449, June 8, 1988]



Sec. 862.1520  5'-Nucleotidase test system.

    (a) Identification. A 5'-nucleotidase test system is a device 
intended to measure the activity of the enzyme 5'-nucleotidase in serum 
and plasma. Measurements of 5'-nucleotidase are used in the diagnosis 
and treatment of liver diseases and in the differentiations between 
liver and bone diseases in the presence of elevated serum alkaline 
phosphatase activity.
    (b) Classification. Class I (general controls). The device is exempt 
from the premarket notification procedures in subpart E of part 807 of 
this chapter subject to Sec. 862.9.

[52 FR 16122, May 1, 1987, as amended at 65 FR 2307, Jan. 14, 2000]



Sec. 862.1530  Plasma oncometry test system.

    (a) Identification. A plasma oncometry test system is a device 
intended to measure plasma oncotic pressure. Plasma oncotic pressure is 
that portion of the total fluid pressure contributed by proteins and 
other molecules too large to pass through a specified membrane. 
Measurements of plasma oncotic pressure are used in the diagnosis and 
treatment of dehydration and circulatory disorders related to low serum 
protein levels and increased capillary permeability, such as edema and 
shock.
    (b) Classification. Class I (general controls). The device is exempt 
from the premarket notification procedures in subpart E of part 807 of 
this chapter subject to Sec. 862.9.

[52 FR 16122, May 1, 1987, as amended at 65 FR 2307, Jan. 14, 2000]



Sec. 862.1535  Ornithine carbamyl transferase test system.

    (a) Identification. An ornithine carbamyl transferase test system is 
a device intended to measure the activity of the enzyme ornithine 
carbamyl transferase (OCT) in serum. Ornithine carbamyl transferase 
measurements are used in the diagnosis and treatment of liver diseases, 
such as infectious hepatitis, acute cholecystitis (inflammation of the 
gall bladder), cirrhosis, and liver metastases.
    (b) Classification. Class I (general controls). The device is exempt 
from the premarket notification procedures in subpart E of part 807 of 
this chapter subject to Sec. 862.9.

[52 FR 16122, May 1, 1987, as amended at 65 FR 2307, Jan. 14, 2000]



Sec. 862.1540  Osmolality test system.

    (a) Identification. An osmolality test system is a device intended 
to measure ionic and nonionic solute concentration in body fluids, such 
as serum and urine. Osmolality measurement is used as an adjunct to 
other tests in the evaluation of a variety of diseases, including kidney 
diseases (e.g., chronic progressive renal failure), diabetes insipidus, 
other endocrine and metabolic disorders, and fluid imbalances.
    (b) Classification. Class I (general controls). The device is exempt 
from the premarket notification procedures in subpart E of part 807 of 
this chapter subject to Sec. 862.9.

[52 FR 16122, May 1, 1987, as amended at 65 FR 2307, Jan. 14, 2000]



Sec. 862.1542  Oxalate test system.

    (a) Identification. An oxalate test system is a device intended to 
measure the concentration of oxalate in urine. Measurements of oxalate 
are used to aid in the diagnosis or treatment of urinary stones or 
certain other metabolic disorders.

[[Page 192]]

    (b) Classification. Class I (general controls). The device is exempt 
from the premarket notification procedures in subpart E of part 807 of 
this chapter subject to Sec. 862.9.

[52 FR 16122, May 1, 1987, as amended at 65 FR 2307, Jan. 14, 2000]



Sec. 862.1545  Parathyroid hormone test system.

    (a) Identification. A parathyroid hormone test system is a device 
intended to measure the levels of parathyroid hormone in serum and 
plasma. Measurements of parathyroid hormone levels are used in the 
differential diagnosis of hypercalcemia (abnormally high levels of 
calcium in the blood) and hypocalcemia (abnormally low levels of calcium 
in the blood) resulting from disorders of calcium metabolism.
    (b) Classification. Class II.



Sec. 862.1550  Urinary pH (nonquantitative) test system.

    (a) Identification. A urinary pH (nonquantitative) test system is a 
device intended to estimate the pH of urine. Estimations of pH are used 
to evaluate the acidity or alkalinity of urine as it relates to numerous 
renal and metabolic disorders and in the monitoring of patients with 
certain diets.
    (b) Classification. Class I (general controls). The device is exempt 
from the premarket notification procedures in subpart E of part 807 of 
this chapter subject to Sec. 862.9.

[52 FR 16122, May 1, 1987, as amended at 65 FR 2307, Jan. 14, 2000]



Sec. 862.1555  Phenylalanine test system.

    (a) Identification. A phenylalanine test system is a device intended 
to measure free phenylalanine (an amino acid) in serum, plasma, and 
urine. Measurements of phenylalanine are used in the diagnosis and 
treatment of congenital phenylketonuria which, if untreated, may cause 
mental retardation.
    (b) Classification. Class II.



Sec. 862.1560  Urinary phenylketones (nonquantitative) test system.

    (a) Identification. A urinary phenylketones (nonquantitative) test 
system is a device intended to identify phenylketones (such as 
phenylpyruvic acid) in urine. The identification of urinary 
phenylketones is used in the diagnosis and treatment of congenital 
phenylketonuria which, if untreated, may cause mental retardation.
    (b) Classification. Class I (general controls). The device is exempt 
from the premarket notification procedures in subpart E of part 807 of 
this chapter subject to Sec. 862.9.

[52 FR 16122, May 1, 1987, as amended at 65 FR 2307, Jan. 14, 2000]



Sec. 862.1565  6-Phosphogluconate dehydrogenase test system.

    (a) Identification. A 6-phosphogluconate dehydrogenase test system 
is a device intended to measure the activity of the enzyme 6-
phosphogluconate dehydrogenase (6 PGD) in serum and erythrocytes. 
Measurements of 6-phosphogluconate dehydrogenase are used in the 
diagnosis and treatment of certain liver diseases (such as hepatitis) 
and anemias.
    (b) Classification. Class I. The device is exempt from the premarket 
notification procedures in subpart E of part 807.

[52 FR 16122, May 1, 1987, as amended at 53 FR 21449, June 8, 1988]



Sec. 862.1570  Phosphohexose isomerase test system.

    (a) Identification. A phosphohexose isomerase test system is a 
device intended to measure the activity of the enzyme phosphohexose 
isomerase in serum. Measurements of phosphohexose isomerase are used in 
the diagnosis and treatment of muscle diseases such as muscular 
dystrophy, liver diseases such as hepatitis or cirrhosis, and metastatic 
carcinoma.
    (b) Classification. Class I (general controls). The device is exempt 
from the premarket notification procedures in subpart E of part 807 of 
this chapter subject to Sec. 862.9.

[52 FR 16122, May 1, 1987, as amended at 65 FR 2307, Jan. 14, 2000]



Sec. 862.1575  Phospholipid test system.

    (a) Identification. A phospholipid test system is a device intended 
to measure phospholipids in serum and plasma. Measurements of 
phospholipids are

[[Page 193]]

used in the diagnosis and treatment of disorders involving lipid (fat) 
metabolism.
    (b) Classification. Class I. The device is exempt from the premarket 
notification procedures in subpart E of part 807.

[52 FR 16122, May 1, 1987, as amended at 53 FR 21449, June 8, 1988]



Sec. 862.1580  Phosphorus (inorganic) test system.

    (a) Identification. A phosphorus (inorganic) test system is a device 
intended to measure inorganic phosphorus in serum, plasma, and urine. 
Measurements of phosphorus (inorganic) are used in the diagnosis and 
treatment of various disorders, including parathyroid gland and kidney 
diseases, and vitamin D imbalance.
    (b) Classification. Class I.



Sec. 862.1585  Human placental lactogen test system.

    (a) Identification. A human placental lactogen test system is a 
device intended to measure the hormone human placental lactogen (HPL), 
(also known as human chorionic somatomammotrophin (HCS)), in maternal 
serum and maternal plasma. Measurements of human placental lactogen are 
used in the diagnosis and clinical management of high-risk pregnancies 
involving fetal distress associated with placental insufficiency. 
Measurements of HPL are also used in pregnancies complicated by 
hypertension, proteinuria, edema, post-maturity, placental 
insufficiency, or possible miscarriage.
    (b) Classification. Class II.



Sec. 862.1590  Porphobilinogen test system.

    (a) Identification. A porphobilinogen test system is a device 
intended to measure porphobilinogen (one of the derivatives of 
hemoglobin which can make the urine a red color) in urine. Measurements 
obtained by this device are used in the diagnosis and treatment of 
porphyrias (primarily inherited diseases associated with disturbed 
porphyrine metabolism), lead poisoning, and other diseases characterized 
by alterations in the heme pathway.
    (b) Classification. Class I (general controls). The device is exempt 
from the premarket notification procedures in subpart E of part 807 of 
this chapter subject to Sec. 862.9.

[52 FR 16122, May 1, 1987, as amended at 65 FR 2307, Jan. 14, 2000]



Sec. 862.1595  Porphyrins test system.

    (a) Identification. A porphyrins test system is a device intended to 
measure porphyrins (compounds formed during the biosynthesis of heme, a 
constituent of hemoglobin, and related compounds) in urine and feces. 
Measurements obtained by this device are used in the diagnosis and 
treatment of lead poisoning, porphyrias (primarily inherited diseases 
associated with disturbed porphyrin metabolism), and other diseases 
characterized by alterations in the heme pathway.
    (b) Classification. Class I (general controls). The device is exempt 
from the premarket notification procedures in subpart E of part 807 of 
this chapter subject to Sec. 862.9.

[52 FR 16122, May 1, 1987, as amended at 65 FR 2308, Jan. 14, 2000]



Sec. 862.1600  Potassium test system.

    (a) Identification. A potassium test system is a device intended to 
measure potassium in serum, plasma, and urine. Measurements obtained by 
this device are used to monitor electrolyte balance in the diagnosis and 
treatment of diseases conditions characterized by low or high blood 
potassium levels.
    (b) Classification. Class II.



Sec. 862.1605  Pregnanediol test system.

    (a) Identification. A pregnanediol test system is a device intended 
to measure pregnanediol (a major urinary metabolic product of 
progesterone) in urine. Measurements obtained by this device are used in 
the diagnosis and treatment of disorders of the ovaries or placenta.
    (b) Classification. Class I (general controls). The device is exempt 
from the premarket notification procedures in subpart E of part 807 of 
this chapter subject to Sec. 862.9.

[52 FR 16122, May 1, 1987, as amended at 65 FR 2308, Jan. 14, 2000]

[[Page 194]]



Sec. 862.1610  Pregnanetriol test system.

    (a) Identification. A pregnanetriol test system is a device intended 
to measure pregnanetriol (a precursor in the biosynthesis of the adrenal 
hormone cortisol) in urine. Measurements obtained by this device are 
used in the diagnosis and treatment of congenital adrenal hyperplasia 
(congenital enlargement of the adrenal gland).
    (b) Classification. Class I (general controls). The device is exempt 
from the premarket notification procedures in subpart E of part 807 of 
this chapter subject to Sec. 862.9.

[52 FR 16122, May 1, 1987, as amended at 65 FR 2308, Jan. 14, 2000]



Sec. 862.1615  Pregnenolone test system.

    (a) Identification. A pregnenolone test system is a device intended 
to measure pregnenolone (a precursor in the biosynthesis of the adrenal 
hormone cortisol and adrenal androgen) in serum and plasma. Measurements 
obtained by this device are used in the diagnosis and treatment of 
diseases of the adrenal cortex or the gonads.
    (b) Classification. Class I (general controls). The device is exempt 
from the premarket notification procedures in subpart E of part 807 of 
this chapter subject to Sec. 862.9.

[52 FR 16122, May 1, 1987, as amended at 65 FR 2308, Jan. 14, 2000]



Sec. 862.1620  Progesterone test system.

    (a) Identification. A progesterone test system is a device intended 
to measure progesterone (a female hormone) in serum and plasma. 
Measurements obtained by this device are used in the diagnosis and 
treatment of disorders of the ovaries or placenta.
    (b) Classification. Class I (general controls). The device is exempt 
from the premarket notification procedures in subpart E of part 807 of 
this chapter subject to Sec. 862.9.

[52 FR 16122, May 1, 1987, as amended at 65 FR 2308, Jan. 14, 2000]



Sec. 862.1625  Prolactin (lactogen) test system.

    (a) Identification. A prolactin (lactogen) test system is a device 
intended to measure the anterior pituitary polypeptide hormone prolactin 
in serum and plasma. Measurements obtained by this device are used in 
the diagnosis and treatment of disorders of the anterior pituitary gland 
or of the hypothalamus portion of the brain.
    (b) Classification. Class I (general controls). The device is exempt 
from the premarket notification procedures in subpart E of part 807 of 
this chapter subject to Sec. 862.9.

[52 FR 16122, May 1, 1987, as amended at 65 FR 2308, Jan. 14, 2000]



Sec. 862.1630  Protein (fractionation) test system.

    (a) Identification. A protein (fractionation) test system is a 
device intended to measure protein fractions in blood, urine, 
cerebrospinal fluid, and other body fluids. Protein fractionations are 
used as a aid in recognizing abnormal proteins in body fluids and 
genetic variants of proteins produced in diseases with tissue 
destruction.
    (b) Classification. Class I (general controls). The device is exempt 
from the premarket notification procedures in subpart E of part 807 of 
this chapter subject to Sec. 862.9.

[52 FR 16122, May 1, 1987, as amended at 65 FR 2308, Jan. 14, 2000]



Sec. 862.1635  Total protein test system.

    (a) Identification. A total protein test system is a device intended 
to measure total protein(s) in serum or plasma. Measurements obtained by 
this device are used in the diagnosis and treatment of a variety of 
diseases involving the liver, kidney, or bone marrow as well as other 
metabolic or nutritional disorders.
    (b) Classification. Class II (special controls). The device is 
exempt from the premarket notification procedures in subpart E of part 
807 of this chapter subject to Sec. 862.9.

[52 FR 16122, May 1, 1987, as amended at 63 FR 59225, Nov. 3, 1998]



Sec. 862.1640  Protein-bound iodine test system.

    (a) Identification. A protein-bound iodine test system is a device 
intended to measure protein-bound iodine in serum. Measurements of 
protein-bound iodine obtained by this device are used

[[Page 195]]

in the diagnosis and treatment of thyroid disorders.
    (b) Classification. Class I. The device is exempt from the premarket 
notification procedures in subpart E of part 807.

[52 FR 16122, May 1, 1987, as amended at 53 FR 21449, June 8, 1988]



Sec. 862.1645  Urinary protein or albumin (nonquantitative) test system.

    (a) Identification. A urinary protein or albumin (nonquantitative) 
test system is a device intended to identify proteins or albumin in 
urine. Identification of urinary protein or albumin (nonquantitative) is 
used in the diagnosis and treatment of disease conditions such as renal 
or heart diseases or thyroid disorders, which are characterized by 
proteinuria or albuminuria.
    (b) Classification. Class I (general controls). The device is exempt 
from the premarket notification procedures in subpart E of part 807 of 
this chapter subject to Sec. 862.9.

[52 FR 16122, May 1, 1987, as amended at 65 FR 2308, Jan. 14, 2000]



Sec. 862.1650  Pyruvate kinase test system.

    (a) Identification. A pyruvate kinase test system is a device 
intended to measure the activity of the enzyme pyruvate kinase in 
erythrocytes (red blood cells). Measurements obtained by this device are 
used in the diagnosis and treatment of various inherited anemias due to 
pyruvate kinase deficiency or of acute leukemias.
    (b) Classification. Class I (general controls). The device is exempt 
from the premarket notification procedures in subpart E of part 807 of 
this chapter subject to Sec. 862.9.

[52 FR 16122, May 1, 1987, as amended at 65 FR 2308, Jan. 14, 2000]



Sec. 862.1655  Pyruvic acid test system.

    (a) Identification. A pyruvic acid test system is a device intended 
to measure pyruvic acid (an intermediate compound in the metabolism of 
carbohydrate) in plasma. Measurements obtained by this device are used 
in the evaluation of electrolyte metabolism and in the diagnosis and 
treatment of acid-base and electrolyte disturbances or anoxia (the 
reduction of oxygen in body tissues).
    (b) Classification. Class I (general controls). The device is exempt 
from the premarket notification procedures in subpart E of part 807 of 
this chapter subject to Sec. 862.9.

[52 FR 16122, May 1, 1987, as amended at 65 FR 2308, Jan. 14, 2000]



Sec. 862.1660  Quality control material (assayed and unassayed).

    (a) Identification. A quality control material (assayed and 
unassayed) for clinical chemistry is a device intended for medical 
purposes for use in a test system to estimate test precision and to 
detect systematic analytical deviations that may arise from reagent or 
analytical instrument variation. A quality control material (assayed and 
unassayed) may be used for proficiency testing in interlaboratory 
surveys. This generic type of device includes controls (assayed and 
unassayed) for blood gases, electrolytes, enzymes, multianalytes (all 
kinds), single (specified) analytes, or urinalysis controls.
    (b) Classification. Class I (general controls). Except when used in 
donor screening tests, unassayed material is exempt from the premarket 
notification procedures in subpart E of part 807 of this chapter subject 
to Sec. 862.9.

[52 FR 16122, May 1, 1987, as amended at 65 FR 2308, Jan. 14, 2000]



Sec. 862.1665  Sodium test system.

    (a) Identification. A sodium test system is a device intended to 
measure sodium in serum, plasma, and urine. Measurements obtained by 
this device are used in the diagnosis and treatment of aldosteronism 
(excessive secretion of the hormone aldosterone), diabetes insipidus 
(chronic excretion of large amounts of dilute urine, accompanied by 
extreme thirst), adrenal hypertension, Addison's disease (caused by 
destruction of the adrenal glands), dehydration, inappropriate 
antidiuretic hormone secretion, or other diseases involving electrolyte 
imbalance.
    (b) Classification. Class II.

[[Page 196]]



Sec. 862.1670  Sorbitol dehydrogenase test system.

    (a) Identification. A sorbitol dehydrogenase test system is a device 
intended to measure the activity of the enzyme sorbitol dehydrogenase in 
serum. Measurements obtained by this device are used in the diagnosis 
and treatment of liver disorders such as cirrhosis or acute hepatitis.
    (b) Classification. Class I. The device is exempt from the premarket 
notification procedures in subpart E of part 807.

[52 FR 16122, May 1, 1987, as amended at 53 FR 21449, June 8, 1988]



Sec. 862.1675  Blood specimen collection device.

    (a) Identification. A blood specimen collection device is a device 
intended for medical purposes to collect and to handle blood specimens 
and to separate serum from nonserum (cellular) components prior to 
further testing. This generic type device may include blood collection 
tubes, vials, systems, serum separators, blood collection trays, or 
vacuum sample tubes.
    (b) Classification. Class II.



Sec. 862.1680  Testosterone test system.

    (a) Identification. A testosterone test system is a device intended 
to measure testosterone (a male sex hormone) in serum, plasma, and 
urine. Measurement of testosterone are used in the diagnosis and 
treatment of disorders involving the male sex hormones (androgens), 
including primary and secondary hypogonadism, delayed or precocious 
puberty, impotence in males and, in females hirsutism (excessive hair) 
and virilization (masculinization) due to tumors, polycystic ovaries, 
and adrenogenital syndromes.
    (b) Classification. Class I.

[52 FR 16122, May 1, 1987; 53 FR 11645, Apr. 8, 1988]



Sec. 862.1685  Thyroxine-binding globulin test system.

    (a) Identification. A thyroxine-binding globulin test system is a 
device intended to measure thyroxine (thyroid)-binding globulin (TBG), a 
plasma protein which binds thyroxine, in serum and plasma. Measurements 
obtained by this device are used in the diagnosis and treatment of 
thyroid diseases.
    (b) Classification. Class II.



Sec. 862.1690  Thyroid stimulating hormone test system.

    (a) Identification. A thyroid stimulating hormone test system is a 
device intended to measure thyroid stimulating hormone, also known as 
thyrotrophin and thyrotrophic hormone, in serum and plasma. Measurements 
of thyroid stimulating hormone produced by the anterior pituitary are 
used in the diagnosis of thyroid or pituitary disorders.
    (b) Classification. Class II.



Sec. 862.1695  Free thyroxine test system.

    (a) Identification. A free thyroxine test system is a device 
intended to measure free (not protein bound) thyroxine (thyroid hormone) 
in serum or plasma. Levels of free thyroxine in plasma are thought to 
reflect the amount of thyroxine hormone available to the cells and may 
therefore determine the clinical metabolic status of thyroxine. 
Measurements obtained by this device are used in the diagnosis and 
treatment of thyroid diseases.
    (b) Classification. Class II.



Sec. 862.1700  Total thyroxine test system.

    (a) Identification. A total thyroxine test system is a device 
intended to measure total (free and protein bound) thyroxine (thyroid 
hormone) in serum and plasma. Measurements obtained by this device are 
used in the diagnosis and treatment of thyroid diseases.
    (b) Classification. Class II.



Sec. 862.1705  Triglyceride test system.

    (a) Identification. A triglyceride test system is a device intended 
to measure triglyceride (neutral fat) in serum and plasma. Measurements 
obtained by this device are used in the diagnosis and treatment of 
patients with diabetes mellitus, nephrosis, liver obstruction, other 
diseases involving lipid metabolism, or various endocrine disorders.
    (b)  Classification. Class I (general controls). The device is 
exempt from the premarket notification procedures

[[Page 197]]

in subpart E of part 807 of this chapter subject to Sec. 862.9.

[52 FR 16122, May 1, 1987, as amended at 65 FR 2308, Jan. 14, 2000]



Sec. 862.1710  Total triiodothyronine test system.

    (a) Identification. A total triiodothyronine test system is a device 
intended to measure the hormone triiodothyronine in serum and plasma. 
Measurements obtained by this device are used in the diagnosis and 
treatment of thyroid diseases such as hyperthyroidism.
    (b) Classification. Class II.



Sec. 862.1715  Triiodothyronine uptake test system.

    (a) Identification. A triiodothyronine uptake test system is a 
device intended to measure the total amount of binding sites available 
for binding thyroid hormone on the thyroxine-binding proteins, thyroid-
binding globulin, thyroxine-binding prealbumin, and albumin of serum and 
plasma. The device provides an indirect measurement of thyrkoxine levels 
in serum and plasma. Measurements of triiodothyronine uptake are used in 
the diagnosis and treatment of thyroid disorders.
    (b) Classification. Class II. The device is exempt from the 
premarket notification procedures in subpart E of part 807 of this 
chapter subject to the limitations in Sec. 862.9.

[52 FR 16122, May 1, 1987, as amended at 64 FR 1124, Jan. 8, 1999]



Sec. 862.1720  Triose phosphate isomerase test system.

    (a) Identification. A triose phosphate isomerase test system is a 
device intended to measure the activity of the enzyme triose phosphate 
isomerase in erythrocytes (red blood cells). Triose phosphate isomerase 
is an enzyme important in glycolysis (the energy-yielding conversion of 
glucose to lactic acid in various tissues). Measurements obtained by 
this device are used in the diagnosis and treatment of congenital triose 
phosphate isomerase enzyme deficiency, which causes a type of hemolytic 
anemia.
    (b) Classification. Class I. The device is exempt from the premarket 
notification procedures in subpart E of part 807.

[52 FR 16122, May 1, 1987, as amended at 53 FR 21449, June 8, 1988]



Sec. 862.1725  Trypsin test system.

    (a) Identification. A trypsin test system is a device intended to 
measure the activity of trypsin (a pancreatic enzyme important in 
digestion for the breakdown of proteins) in blood and other body fluids 
and in feces. Measurements obtained by this device are used in the 
diagnosis and treatment of pancreatic disease.
    (b)  Classification. Class I (general controls). The device is 
exempt from the premarket notification procedures in subpart E of part 
807 of this chapter subject to Sec. 862.9.

[52 FR 16122, May 1, 1987, as amended at 65 FR 2308, Jan. 14, 2000]



Sec. 862.1730  Free tyrosine test system.

    (a) Identification. A free tyrosine test system is a device intended 
to measure free tyrosine (an amono acid) in serum and urine. 
Measurements obtained by this device are used in the diagnosis and 
treatment of diseases such as congenital tyrosinemia (a disease that can 
cause liver/kidney disorders) and as an adjunct to the measurement of 
phenylalanine in detecting congenital phenylketonuria (a disease that 
can cause brain damage).
    (b) Classification. Class I.



Sec. 862.1770  Urea nitrogen test system.

    (a) Identification. A urea nitrogen test system is a device intended 
to measure urea nitrogen (an end-product of nitrogen metabolism) in 
whole blood, serum, plasma, and urine. Measurements obtained by this 
device are used in the diagnosis and treatment of certain renal and 
metabolic diseases.
    (b) Classification. Class II.



Sec. 862.1775  Uric acid test system.

    (a) Identification. A uric acid test system is a device intended to 
measure uric acid in serum, plasma, and urine. Measurements obtained by 
this device are used in the diagnosis and treatment of numerous renal 
and metabolic disorders, including renal failure, gout, leukemia, 
psoriasis, starvation or

[[Page 198]]

other wasting conditions, and of patients receiving cytotoxic drugs.
    (b) Classification. Class I.



Sec. 862.1780  Urinary calculi (stones) test system.

    (a) Identification. A urinary calculi (stones) test system is a 
device intended for the analysis of urinary calculi. Analysis of urinary 
calculi is used in the diagnosis and treatment of calculi of the urinary 
tract.
    (b)  Classification. Class I (general controls). The device is 
exempt from the premarket notification procedures in subpart E of part 
807 of this chapter subject to Sec. 862.9.

[52 FR 16122, May 1, 1987, as amended at 65 FR 2308, Jan. 14, 2000]



Sec. 862.1785  Urinary urobilinogen (nonquantitative) test system.

    (a) Identification. A urinary urobilinogen (nonquantitative) test 
system is a device intended to detect and estimate urobilinogen (a bile 
pigment degradation product of red cell hemoglobin) in urine. 
Estimations obtained by this device are used in the diagnosis and 
treatment of liver diseases and hemolytic (red cells) disorders.
    (b)  Classification. Class I (general controls). The device is 
exempt from the premarket notification procedures in subpart E of part 
807 of this chapter subject to Sec. 862.9.

[52 FR 16122, May 1, 1987, as amended at 65 FR 2308, Jan. 14, 2000]



Sec. 862.1790  Uroporphyrin test system.

    (a) Identification. A uroporphyrin test system is a device intended 
to measure uroporphyrin in urine. Measurements obtained by this device 
are used in the diagnosis and treatment of porphyrias (primarily 
inherited diseases associated with disturbed porphyrin metabolism), lead 
poisoning, and other diseases characterized by alterations in the heme 
pathway.
    (b) Classification. Class I (general controls). The device is exempt 
from the premarket notification procedures in subpart E of part 807 of 
this chapter subject to Sec. 862.9.

[52 FR 16122, May 1, 1987, as amended at 65 FR 2308, Jan. 14, 2000]



Sec. 862.1795  Vanilmandelic acid test system.

    (a) Identification. A vanilmandelic acid test system is a device 
intended to measure vanilmandelic acid in urine. Measurements of 
vanilmandelic acid obtained by this device are used in the diagnosis and 
treatment of neuroblastoma, pheochromocytoma, and certain hypertensive 
conditions.
    (b) Classification. Class I (general controls). The device is exempt 
from the premarket notification procedures in subpart E of part 807 of 
this chapter subject to Sec. 862.9.

[52 FR 16122, May 1, 1987, as amended at 65 FR 2308, Jan. 14, 2000]



Sec. 862.1805  Vitamin A test system.

    (a) Identification. A vitamin A test system is a device intended to 
measure vitamin A in serum or plasma. Measurements obtained by this 
device are used in the diagnosis and treatment of vitamin A deficiency 
conditions, including night blindness, or skin, eye, or intestinal 
disorders.
    (b) Classification. Class I (general controls). The device is exempt 
from the premarket notification procedures in subpart E of part 807 of 
this chapter subject to Sec. 862.9.

[52 FR 16122, May 1, 1987, as amended at 65 FR 2308, Jan. 14, 2000]



Sec. 862.1810  Vitamin B12 test system.

    (a) Identification. A vitamin B12 test system is a device 
intended to measure vitamin B12 in serum, plasma, and urine. 
Measurements obtained by this device are used in the diagnosis and 
treatment of anemias of gastrointestinal malabsorption.
    (b) Classification. Class II.



Sec. 862.1815  Vitamin E test system.

    (a) Identification. A vitamin E test system is a device intended to 
measure vitamin E (tocopherol) in serum. Measurements obtained by this 
device are used in the diagnosis and treatment of infants with vitamin E 
deficiency syndrome.

[[Page 199]]

    (b) Classification. Class I. The device is exempt from the premarket 
notification procedures in subpart E of part 807.

[52 FR 16122, May 1, 1987, as amended at 53 FR 21449, June 8, 1988]



Sec. 862.1820  Xylose test system.

    (a) Identification. A xylose test system is a device intended to 
measure xylose (a sugar) in serum, plasma, and urine. Measurements 
obtained by this device are used in the diagnosis and treatment of 
gastrointestinal malabsorption syndrome (a group of disorders in which 
there is subnormal absorption of dietary constituents and thus excessive 
loss from the body of the nonabsorbed substances).
    (b) Classification. Class I (general controls). The device is exempt 
from the premarket notification procedures in subpart E of part 807 of 
this chapter subject to Sec. 862.9.

[52 FR 16122, May 1, 1987, as amended at 65 FR 2308, Jan. 14, 2000]



Sec. 862.1825  Vitamin D test system.

     (a) Identification. A vitamin D test system is a device intended 
for use in clinical laboratories for the quantitative determination of 
25-hydroxyvitamin D (25-OH-D) and other hydroxylated metabolites of 
vitamin D in serum or plasma to be used in the assessment of vitamin D 
sufficiency.
     (b) Classification. Class II (special controls). Vitamin D test 
systems must comply with the following special controls:
    (1) Labeling in conformance with 21 CFR 809.10 and
    (2) Compliance with existing standards of the National Committee on 
Clinical Laboratory Standards.

[63 FR 40366, July 29, 1998]



               Subpart C--Clinical Laboratory Instruments



Sec. 862.2050  General purpose laboratory equipment labeled or promoted for a specific medical use.

    (a) Identification. General purpose laboratory equipment labeled or 
promoted for a specific medical use is a device that is intended to 
prepare or examine specimens from the human body and that is labeled or 
promoted for a specific medical use.
    (b) Classification. Class I. The device identified in paragraph (a) 
of this section is exempt from the premarket notification procedures in 
subpart E of part 807 and is exempt from the current good manufacturing 
practice regulations in part 820, with the exception of Sec. 820.180, 
with respect to general requirements concerning records, and 
Sec. 820.198, with respect to complaint files.



Sec. 862.2100  Calculator/data processing module for clinical use.

    (a) Identification. A calculator/data processing module for clinical 
use is an electronic device intended to store, retrieve, and process 
laboratory data.
    (b) Classification. Class I. The device is exempt from the premarket 
notification procedures in subpart E of part 807.

[52 FR 16122, May 1, 1987, as amended at 53 FR 21449, June 8, 1988]



Sec. 862.2140  Centrifugal chemistry analyzer for clinical use.

    (a) Identification. A centrifugal chemistry analyzer for clinical 
use is an automatic device intended to centrifugally mix a sample and a 
reagent and spectrophotometrically measure concentrations of the sample 
constituents. This device is intended for use in conjunction with 
certain materials to measure a variety of analytes.
    (b) Classification. Class I (general controls). The device is exempt 
from the premarket notification procedures in subpart E of part 807 of 
this chapter subject to Sec. 862.9.

[52 FR 16122, May 1, 1987, as amended at 65 FR 2308, Jan. 14, 2000]



Sec. 862.2150  Continuous flow sequential multiple chemistry analyzer for clinical use.

    (a) Identification. A continuous flow sequential multiple chemistry 
analyzer for clinical use is a modular analytical instrument intended to 
simultaneously perform multiple chemical procedures using the principles 
of automated continuous flow systems. This device is intended for use in 
conjunction with certain materials to measure a variety of analytes.

[[Page 200]]

    (b)  Classification. Class I (general controls). The device is 
exempt from the premarket notification procedures in subpart E of part 
807 of this chapter subject to Sec. 862.9.

[52 FR 16122, May 1, 1987, as amended at 65 FR 2308, Jan. 14, 2000]



Sec. 862.2160  Discrete photometric chemistry analyzer for clinical use.

    (a) Identification. A discrete photometric chemistry analyzer for 
clinical use is a device intended to duplicate manual analytical 
procedures by performing automatically various steps such as pipetting, 
preparing filtrates, heating, and measuring color intensity. This device 
is intended for use in conjunction with certain materials to measure a 
variety of analytes. Different models of the device incorporate various 
instrumentation such as micro analysis apparatus, double beam, single, 
or dual channel photometers, and bichromatic 2-wavelength photometers. 
Some models of the device may include reagent-containing components that 
may also serve as reaction units.
    (b) Classification. Class I (general controls). The device is exempt 
from the premarket notification procedures in subpart E of part 807 of 
this chapter subject to Sec. 862.9.

[52 FR 16122, May 1, 1987, as amended at 65 FR 2309, Jan. 14, 2000]



Sec. 862.2170  Micro chemistry analyzer for clinical use.

    (a) Identification. A micro chemistry analyzer for clinical use is a 
device intended to duplicate manual analytical procedures by performing 
automatically various steps such as pipetting, preparing filtrates, 
heating, and measuring color intensity. The distinguishing 
characteristic of the device is that it requires only micro volume 
samples obtainable from pediatric patients. This device is intended for 
use in conjunction with certain materials to measure a variety of 
analytes.
    (b) Classification. Class I (general controls). The device is exempt 
from the premarket notification procedures in subpart E of part 807 of 
this chapter subject to Sec. 862.9.

[52 FR 16122, May 1, 1987, as amended at 65 FR 2309, Jan. 14, 2000]



Sec. 862.2230  Chromatographic separation material for clinical use.

    (a) Identification. A chromatographic separation material for 
clinical use is a device accessory (e.g., ion exchange absorbents, ion 
exchagne resins, and ion papers) intended for use in ion exchange 
chromatography, a procedure in which a compound is separated from a 
solution.
    (b) Classification. Class I. The device is exempt from the premarket 
notification procedures in subpart E of part 807 of this chapter.

[52 FR 16122, May 1, 1987, as amended at 61 FR 1119, Jan. 16, 1996]



Sec. 862.2250  Gas liquid chromatography system for clinical use.

    (a) Identification. A gas liquid chromatography system for clinical 
use is a device intended to separate one or more drugs or compounds from 
a mixture. Each of the constituents in a vaporized mixture of compounds 
is separated according to its vapor pressure. The device may include 
accessories such as columns, gases, column supports, and liquid coating.
    (b) Classification. Class I (general controls). The device is exempt 
from the premarket notification procedures in subpart E of part 807 of 
this chapter subject to Sec. 862.9.

[52 FR 16122, May 1, 1987, as amended at 65 FR 2309, Jan. 14, 2000]



Sec. 862.2260  High pressure liquid chromatography system for clinical use.

    (a) Identification. A high pressure liquid chromatography system for 
clinical use is a device intended to separate one or more drugs or 
compounds from a solution by processing the mixture of compounds 
(solutes) through a column packed with materials of uniform size 
(stationary phase) under the influence of a high pressure liquid (mobile 
phase). Separation of the solutes occurs either by absorption, sieving, 
partition, or selective affinity.
    (b) Classification. Class I (general controls). The device is exempt 
from the

[[Page 201]]

premarket notification procedures in subpart E of part 807 of this 
chapter subject to Sec. 862.9.

[52 FR 16122, May 1, 1987, as amended at 65 FR 2309, Jan. 14, 2000]



Sec. 862.2270  Thin-layer chromatography system for clinical use.

    (a) Identification. A thin-layer chromatography (TLC) system for 
clinical use is a device intended to separate one or more drugs or 
compounds from a mixture. The mixture of compounds is absorbed onto a 
stationary phase or thin layer of inert material (e.g., cellulose, 
alumina, etc.) and eluted off by a moving solvent (moving phase) until 
equilibrium occurs between the two phases.
    (b) Classification. Class I (general controls). The device is exempt 
from the premarket notification procedures in subpart E of part 807 of 
this chapter subject to Sec. 862.9. Particular components of TLC 
systems, i.e., the thin-layer chromatography apparatus, TLC atomizer, 
TLC developing tanks, and TLC ultraviolet light, are exempt from the 
current good manufacturing practice regulations in part 820 of this 
chapter, with the exception of Sec. 820.180 of this chapter, with 
respect to general requirements concerning records, and Sec. 820.198 of 
this chapter, with respect to complaint files.

[52 FR 16122, May 1, 1987, as amended at 65 FR 2309, Jan. 14, 2000]



Sec. 862.2300  Colorimeter, photometer, or spectrophotometer for clinical use.

    (a) Identification. A colorimeter, a photometer, or a 
spectrophotometer for clinical use is an instrument intended to measure 
radiant energy emitted, transmitted, absorbed, or reflected under 
controlled conditions. The device may include a monochromator to produce 
light of a specific wavelength.
    (b) Classification. Class I (general controls). The device is exempt 
from the premarket notification procedures in subpart E of part 807 of 
this chapter subject to Sec. 862.9.

[52 FR 16122, May 1, 1987, as amended at 65 FR 2309, Jan. 14, 2000]



Sec. 862.2310  Clinical sample concentrator.

    (a) Identification. A clinical sample concentrator is a device 
intended to concentrate (by dialysis, evaporation, etc.) serum, urine, 
cerebrospinal fluid, and other body fluids before the fluids are 
analyzed.
    (b) Classification. Class I. The device is exempt from the premarket 
notification procedures in subpart E of part 807 of this chapter.

[52 FR 16122, May 1, 1987, as amended at 60 FR 38899, July 28, 1995]



Sec. 862.2320  Beta or gamma counter for clinical use.

    (a) Identification. A beta or gamma counter for clinical use is a 
device intended to detect and count beta or gamma radiation emitted by 
clinical samples. Clinical samples are prepared by addition of a 
radioactive reagent to the sample. These measurements are useful in the 
diagnosis and treatment of various disorders.
    (b) Classification. Class I. The device is exempt from the premarket 
notification procedures in subpart E of part 807 of this chapter.

[52 FR 16122, May 1, 1987, as amended at 60 FR 38900, July 28, 1995]



Sec. 862.2400  Densitometer/scanner (integrating, reflectance, TLC, or radiochromatogram) for clinical use.

    (a) Identification. A densitometer/scanner (integrating, 
reflectance, thin-layer chromatography, or radiochromatogram) for 
clinical use is device intended to measure the concentration of a 
substance on the surface of a film or other support media by either a 
photocell measurement of the light transmission through a given area of 
the medium or, in the case of the radiochromatogram scanner, by 
measurement of the distribution of a specific radio-active element on a 
radiochromatogram.
    (b) Classification. Class I (general controls). The device is exempt 
from the premarket notification procedures in subpart E of part 807 of 
this chapter subject to Sec. 862.9.

[52 FR 16122, May 1, 1987, as amended at 65 FR 2309, Jan. 14, 2000]

[[Page 202]]



Sec. 862.2485  Electrophoresis apparatus for clinical use.

    (a) Identification. An electrophoresis apparatus for clinical use is 
a device intended to separate molecules or particles, including plasma 
proteins, lipoproteins, enzymes, and hemoglobulins on the basis of their 
net charge in specified buffered media. This device is used in 
conjunction with certain materials to measure a variety of analytes as 
an aid in the diagnosis and treatment of certain disorders.
    (b) Classification. Class I. The device is exempt from the premarket 
notification procedures in subpart E of part 807 of this chapter.

[52 FR 16122, May 1, 1987, as amended at 60 FR 38900, July 28, 1995]



Sec. 862.2500  Enzyme analyzer for clinical use.

    (a) Identification. An enzyme analyzer for clinical use is a device 
intended to measure enzymes in plasma or serum by nonkinetic or kinetic 
measurement of enzyme-catalyzed reactions. This device is used in 
conjunction with certain materials to measure a variety of enzymes as an 
aid in the diagnosis and treatment of certain enzyme-related disorders.
    (b) Classification. Class I (general controls). The device is exempt 
from the premarket notification procedures in subpart E of part 807 of 
this chapter subject to Sec. 862.9.

[52 FR 16122, May 1, 1987, as amended at 65 FR 2309, Jan. 14, 2000]



Sec. 862.2540  Flame emission photometer for clinical use.

    (a) Identification. A flame emission photometer for clinical use is 
a device intended to measure the concentration of sodium, potassium, 
lithium, and other metal ions in body fluids. Abnormal variations in the 
concentration of these substances in the body are indicative of certain 
disorders (e.g., electrolyte imbalance and heavy metal intoxication) and 
are, therefore, useful in diagnosis and treatment of those disorders.
    (b) Classification. Class I (general controls). The device is exempt 
from the premarket notification procedures in subpart E of part 807 of 
this chapter subject to Sec. 862.9.

[52 FR 16122, May 1, 1987, as amended at 65 FR 2309, Jan. 14, 2000]



Sec. 862.2560  Fluorometer for clinical use.

    (a) Identification. A fluorometer for clinical use is a device 
intended to measure by fluorescence certain analytes. Fluorescence is 
the property of certain substances of radiating, when illuminated, a 
light of a different wavelength. This device is used in conjunction with 
certain materials to measure a variety of analytes.
    (b) Classification. Class I (general controls). The device is exempt 
from the premarket notification procedures in subpart E of part 807 of 
this chapter subject to Sec. 862.9.

[52 FR 16122, May 1, 1987, as amended at 65 FR 2309, Jan. 14, 2000]



Sec. 862.2680  Microtitrator for clinical use.

    (a) Identification. A microtitrator for clinical use is a device 
intended for use in micronanalysis to measure the concentration of a 
substance by reacting it with a measure ``micro'' volume of a known 
standardized solution.
    (b) Classification. Class I (general controls). The device is exempt 
from the premarket notification procedures in subpart E of part 807 of 
this chapter subject to Sec. 862.9.

[52 FR 16122, May 1, 1987, as amended at 65 FR 2309, Jan. 14, 2000]



Sec. 862.2700  Nephelometer for clinical use.

    (a) Identification. A nephelometer for clinical use is a device 
intended to estimate the concentration of particles in a suspension by 
measuring their light scattering properties (the deflection of light 
rays by opaque particles in their path). The device is used in 
conjunction with certain materials to measure the concentration of a 
variety of analytes.
    (b) Classification. Class I (general controls). The device is exempt 
from the premarket notification procedures in subpart E of part 807 of 
this chapter subject to Sec. 862.9.

[52 FR 16122, May 1, 1987, as amended at 65 FR 2309, Jan. 14, 2000]

[[Page 203]]



Sec. 862.2720  Plasma oncometer for clinical use.

    (a) Identification. A plasma oncometer for clinical use is a device 
intended to measure plasma oncotic pressure, which is that portion of 
the total plasma osmotic pressure contributed by protein and other 
molecules too large to pass through a specified semipermeable membrane. 
Because variations in plasma oncotic pressure are indications of certain 
disorders, measurements of the variations are useful in the diagnosis 
and treatment of these disorders.
    (b) Classification. Class I. The device is exempt from the premarket 
notification procedures in subpart E of part 807 of this chapter.

[52 FR 16122, May 1, 1987, as amended at 60 FR 38900, July 28, 1995]



Sec. 862.2730  Osmometer for clinical use.

    (a) Identification. An osmometer for clinical use is a device 
intended to measure the osmotic pressure of body fluids. Osmotic 
pressure is the pressure required to prevent the passage of a solution 
with a lesser solute concentration into a solution with greater solute 
concentration when the two solutions are separated by a semipermeable 
membrane. The concentration of a solution affects its osmotic pressure, 
freezing point, and other physiochemical properties. Osmometers 
determine osmotic pressure by methods such as the measurement of the 
freezing point. Measurements obtained by this device are used in the 
diagnosis and treatment of body fluid disorders.
    (b) Classification. Class I (general controls). The device is exempt 
from the premarket notification procedures in subpart E of part 807 of 
this chapter subject to Sec. 862.9.

[52 FR 16122, May 1, 1987, as amended at 65 FR 2309, Jan. 14, 2000]



Sec. 862.2750  Pipetting and diluting system for clinical use.

    (a) Identification. A pipetting and diluting system for clinical use 
is a device intended to provide an accurately measured volume of liquid 
at a specified temperature for use in certain test procedures. This 
generic type of device system includes serial, manual, automated, and 
semi-automated dilutors, pipettors, dispensers, and pipetting stations.
    (b) Classification. Class I (general controls). The device is exempt 
from the premarket notification procedures in subpart E of part 807 of 
this chapter subject to Sec. 862.9.

[52 FR 16122, May 1, 1987, as amended at 65 FR 2309, Jan. 14, 2000]



Sec. 862.2800  Refractometer for clinical use.

    (a) Identification. A refractometer for clinical use is a device 
intended to determine the amount of solute in a solution by measuring 
the index of refraction (the ratio of the velocity of light in a vacuum 
to the velocity of light in the solution). The index of refraction is 
used to measure the concentration of certain analytes (solutes), such a 
plasma total proteins and urinary total solids. Measurements obtained by 
this device are used in the diagnosis and treatment of certain 
conditions.
    (b) Classification. Class I. The device is exempt from the premarket 
notification procedures in subpart E of part 807 of this chapter.

[52 FR 16122, May 1, 1987, as amended at 60 FR 38900, July 28, 1995]



Sec. 862.2850  Atomic absorption spectrophotometer for clinical use.

    (a) Identification. An atomic absorption spectrophotometer for 
clinical use is a device intended to identify and measure elements and 
metals (e.g., lead and mercury) in human specimens. The metal elements 
are identified according to the wavelength and intensity of the light 
that is absorbed when the specimen is converted to the atomic vapor 
phase. Measurements obtained by this device are used in the diagnosis 
and treatment of certain conditions.
    (b) Classification. Class I (general controls). The device is exempt 
from the premarket notification procedures in subpart E of part 807 of 
this chapter subject to Sec. 862.9.

[52 FR 16122, May 1, 1987, as amended at 65 FR 2309, Jan. 14, 2000]

[[Page 204]]



Sec. 862.2860  Mass spectrometer for clinical use.

    (a) Identification. A mass spectrometer for clinical use is a device 
intended to identify inorganic or organic compounds (e.g., lead, 
mercury, and drugs) in human specimens by ionizing the compound under 
investigation and separating the resulting ions by means of an 
electrical and magnetic field according to their mass.
    (b) Classification. Class I (general controls). The device is exempt 
from the premarket notification procedures in subpart E of part 807 of 
this chapter subject to Sec. 862.9.

[52 FR 16122, May 1, 1987, as amended at 65 FR 2309, Jan. 14, 2000]



Sec. 862.2900  Automated urinalysis system.

    (a) Identification. An automated urinalysis system is a device 
intended to measure certain of the physical properties and chemical 
constituents of urine by procedures that duplicate manual urinalysis 
systems. This device is used in conjunction with certain materials to 
measure a variety of urinary analytes.
    (b) Classification. Class I (general controls). The device is exempt 
from the premarket notification procedures in subpart E of part 807 of 
this chapter subject to Sec. 862.9.

[52 FR 16122, May 1, 1987, as amended at 65 FR 2309, Jan. 14, 2000]



Sec. 862.2920  Plasma viscometer for clinical use.

    (a) Identification. A plasma viscometer for clinical use is a device 
intended to measure the viscosity of plasma by determining the time 
period required for the plasma to flow a measured distance through a 
calibrated glass tube. Measurements obtained by this device are used to 
monitor changes in the amount of solids present in plasma in various 
disorders.
    (b) Classification. Class I. The device is exempt from the premarket 
notification procedures in subpart E of part 807 of this chapter.

[52 FR 16122, May 1, 1987, as amended at 60 FR 38900, July 28, 1995]



               Subpart D--Clinical Toxicology Test Systems



Sec. 862.3030  Acetaminophen test system.

    (a) Identification. An acetaminophen test system is a device 
intended to measure acetaminophen, an analgestic and fever reducing 
drug, in serum. Measurements obtained by this device are used in the 
diagnosis and treatment of acetaminophen overdose.
    (b) Classification. Class II.



Sec. 862.3035  Amikacin test system.

    (a) Identification. An amikacin test system is a device intended to 
measure amikacin, an aminoglycoside antibiotic drug, in serum and 
plasma. Measurements obtained by this device are used in the diagnosis 
and treatment of amikacin overdose and in monitoring levels of amikacin 
to ensure appropriate therapy.
    (b) Classification. Class II.



Sec. 862.3040  Alcohol test system.

    (a) Identification. An alcohol test system is a device intented to 
measure alcohol (e.g., ethanol, methanol, isopropanol, etc.) in human 
body fluids (e.g., serum, whole blood, and urine). Measurements obtained 
by this device are used in the diagnosis and treatment of alcohol 
intoxication and poisoning.
    (b) Classification. Class II.



Sec. 862.3050  Breath-alcohol test system.

    (a) Identification. A breath-alcohol test system is a device intened 
to measure alcohol in the human breath. Measurements obtained by this 
device are used in the diagnosis of alcohol intoxication.
    (b) Classification. Class I.



Sec. 862.3100  Amphetamine test system.

    (a) Identification. An amphetamine test system is a device intended 
to measure amphetamine, a central nervous system stimulating drug, in 
plasma and urine. Measurements obtained by this device are used in the 
diagnosis and treatment of amphetamine use or overdose and in monitoring 
levels of amphetamine to ensure appropriate therapy.
    (b) Classification. Class II.

[[Page 205]]



Sec. 862.3110  Antimony test system.

    (a) Identification. An antimony test system is a device intended to 
measure antimony, a heavy metal, in urine, blood, vomitus, and stomach 
contents. Measurements obtained by this device are used in the diagnosis 
and treatment of antimony poisoning.
    (b) Classification. Class I.



Sec. 862.3120  Arsenic test system.

    (a) Identification. An arsenic test system is a device intended to 
measure arsenic, a poisonous heavy metal, in urine, vomitus, stomach 
contents, nails, hair, and blood. Measurements obtained by this device 
are used in the diagnosis and treatment of arsenic poisoning.
    (b) Classification. Class I.



Sec. 862.3150  Barbiturate test system.

    (a) Identification. A barbiturate test system is a device intended 
to measure barbiturates, a class of hypnotic and sedative drugs, in 
serum, urine, and gastric contents. Measurements obtained by this device 
are used in the diagnosis and treatment of barbiturate use or overdose 
and in monitoring levels of barbiturate to ensure appropriate therapy.
    (b) Classification. Class II.



Sec. 862.3170  Benzodiazepine test system.

    (a) Identification. A benzodiazepine test system is a device 
intended to measure any of the benzodiazepine compounds, sedative and 
hypnotic drugs, in blood, plasma, and urine. The benzodiazepine 
compounds include chlordiazepoxide, diazepam, oxazepam, chlorzepate, 
flurazepam, and nitrazepam. Measurements obtained by this device are 
used in the diagnosis and treatment of benzodiazepine use or overdose 
and in monitoring levels of benzodiazepines to ensure appropriate 
therapy.
    (b) Classification. Class II.



Sec. 862.3200  Clinical toxicology calibrator.

    (a) Identification. A clinical toxicology calibrator is a device 
intended for medical purposes for use in a test system to establish 
points of reference that are used in the determination of values in the 
measurement of substances in human specimens. A clinical toxicology 
calibrator can be a mixture of drugs or a specific material for a 
particular drug (e.g., ethanol, lidocaine, etc.). (See also Sec. 862.2 
in this part.)
    (b) Classification. Class II.



Sec. 862.3220  Carbon monoxide test system.

    (a) Identification. A carbon monoxide test system is a device 
intended to measure carbon monoxide or carboxyhemoglobin (carbon 
monoxide bound to the hemoglobin in the blood) in blood. Measurements 
obtained by this device are used in the diagnosis and treatment of or 
confirmation of carbon monoxide poisoning.
    (b) Classification. Class I.



Sec. 862.3240  Cholinesterase test system.

    (a) Identification. A cholinesterase test system is a device 
intended to measure cholinesterase (an enzyme that catalyzes the 
hydrolysis of acetylcholine to choline) in human specimens. There are 
two principal types of cholinesterase in human tissues. True 
cholinesterase is present at nerve endings and in erythrocytes (red 
blood cells) but is not present in plasma. Pseudo cholinesterase is 
present in plasma and liver but is not present in erythrocytes. 
Measurements obtained by this device are used in the diagnosis and 
treatment of cholinesterase inhibition disorders (e.g., insecticide 
poisoning and succinylcholine poisoning).
    (b) Classification. Class I.



Sec. 862.3250  Cocaine and cocaine metabolite test system.

    (a) Identification. A cocaine and cocaine metabolite test system is 
a device intended to measure cocaine and a cocaine metabolite 
(benzoylecgonine) in serum, plasma, and urine. Measurements obtained by 
this device are used in the diagnosis and treatment of cocaine use or 
overdose.
    (b) Classification. Class II.



Sec. 862.3270  Codeine test system.

    (a) Identification. A codeine test system is a device intended to 
measure codeine (a narcotic pain-relieving drug)

[[Page 206]]

in serum and urine. Measurements obtained by this device are used in the 
diagnosis and treatment of codeine use or overdose and in monitoring 
levels of codeine to ensure appropriate therapy.
    (b) Classification. Class II.



Sec. 862.3280  Clinical toxicology control material.

    (a) Identification. A clinical toxicology control material is a 
device intended to provide an estimation of the precision of a device 
test system and to detect and monitor systematic deviations from 
accuracy resulting from reagent or instrument defects. This generic type 
of device includes various single, and multi-analyte control materials.
    (b) Classification. Class I (general controls). Except when used in 
donor screening, unassayed material is exempt from the premarket 
notification procedures in subpart E of part 807 of this chapter subject 
to Sec. 862.9.

[52 FR 16122, May 1, 1987, as amended at 65 FR 2309, Jan. 14, 2000]



Sec. 862.3300  Digitoxin test system.

    (a) Identification. A digitoxin test system is a device intended to 
measure digitoxin, a cardiovascular drug, in serum and plasma. 
Measurements obtained by this device are used in the diagnosis and 
treatment of digitoxin overdose and in monitoring levels of digitoxin to 
ensure appropriate therapy.
    (b) Classification. Class II.



Sec. 862.3320  Digoxin test system.

    (a) Identification. A digoxin test system is a device intended to 
measure digoxin, a cardiovascular drug, in serum and plasma. 
Measurements obtained by this device are used in the diagnosis and 
treatment of digoxin overdose and in monitoring levels of digoxin to 
ensure appropriate therapy.
    (b) Classification. Class II.



Sec. 862.3350  Diphenylhydantoin test system.

    (a) Identification. A diphenylhydantoin test system is a device 
intended to measure diphenylhydantoin, an antiepileptic drug, in human 
specimens. Measurements obtained by this device are used in the 
diagnosis and treatment of diphenylhydantoin overdose and in monitoring 
levels of diphenylhydantoin to ensure appropriate therapy.
    (b) Classification. Class II.



Sec. 862.3380  Ethosuximide test system.

    (a) Identification. An ethosuximide test system is a device intended 
to measure ethosuximide, an antiepileptic drug, in human specimens. 
Measurements obtained by this device are used in the diagnosis and 
treatment of ethosuximide overdose and in monitoring levels of 
ethosuximide to ensure appropriate therapy.
    (b) Classification. Class II.



Sec. 862.3450  Gentamicin test system.

    (a) Identification. A gentamicin test system is a device intended to 
measure gentamicin, an antibiotic drug, in human specimens. Measurements 
obtained by this device are used in the diagnosis and treatment of 
gentamicin overdose and in monitoring levels of gentamicin to ensure 
appropriate therapy.
    (b) Classification. Class II.



Sec. 862.3520  Kanamycin test system.

    (a) Identification. A kanamycin test system is a device intended to 
measure kanamycin, an antibiotic drug, in plasma and serum. Measurements 
obtained by this device are used in the diagnosis and treatment of 
kanamycin overdose and in monitoring levels of kanamycin to ensure 
appropriate therapy.
    (b) Classification. Class II.



Sec. 862.3550  Lead test system.

    (a) Identification. A lead test system is a device intended to 
measure lead, a heavy metal, in blood and urine. Measurements obtained 
by this device are used in the diagnosis and treatment of lead 
poisoning.
    (b) Classification. Class II.



Sec. 862.3555  Lidocaine test system.

    (a) Identification. A lidocaine test system is a device intended to 
measure lidocaine, an antiarrythmic and anticonvulsant drug, in serum 
and plasma. Measurements obtained by this device are used in the 
diagnosis and treatment of lidocaine overdose or in

[[Page 207]]

monitoring levels of lidocaine to ensure appropriate therapy.
    (b) Classification. Class II.



Sec. 862.3560  Lithium test system.

    (a) Identification. A lithium test system is a device intended to 
measure lithium (from the drug lithium carbonate) in serum or plasma. 
Measurements of lithium are used to assure that the proper drug dosage 
is administered in the treatment of patients with mental disturbances, 
such as manic-depressive illness (bipolar disorder).
    (b) Classification. Class II.



Sec. 862.3580  Lysergic acid diethylamide (LSD) test system.

    (a) Identification. A lysergic acid diethylamide (LSD) test system 
is a device intended to measure lysergic acid diethylamide, a 
hallucinogenic drug, in serum, urine, and gastric contents. Measurements 
obtained by this device are used in the diagnosis and treatment of LSD 
use or overdose.
    (b) Classification. Class II.



Sec. 862.3600  Mercury test system.

    (a) Identification. A mercury test system is a device intended to 
measure mercury, a heavy metal, in human specimens. Measurements 
obtained by this device are used in the diagnosis and treatment of 
mercury poisoning.
    (b) Classification. Class I.



Sec. 862.3610  Methamphetamine test system.

    (a) Identification. A methamphetamine test system is a device 
intended to measure methamphetamine, a central nervous system 
stimulating drug, in serum, plasma, and urine. Measurements obtained by 
this device are used in the diagnosis and treatment of methamphetamine 
use or overdose.
    (b) Classification. Class II.



Sec. 862.3620  Methadone test system.

    (a) Identification. A methadone test system is a device intended to 
measure methadone, an addictive narcotic pain-relieving drug, in serum 
and urine. Measurements obtained by this device are used in the 
diagnosis and treatment of methadone use or overdose and to determine 
compliance with regulations in methadone maintenance treatment.
    (b) Classification. Class II.



Sec. 862.3630  Methaqualone test system.

    (a) Identification. A methaqualone test system is a device intended 
to measure methaqualone, a hypnotic and sedative drug, in urine. 
Measurements obtained by this device are used in the diagnosis and 
treatment of methaqualone use or overdose.
    (b) Classification. Class II.



Sec. 862.3640  Morphine test system.

    (a) Identification. A morphine test system is a device intended to 
measure morphine, an addictive narcotic pain-relieving drug, and its 
analogs in serum, urine, and gastric contents. Measurements obtained by 
this device are used in the diagnosis and treatment of morphine use or 
overdose and in monitoring levels of morphine and its analogs to ensure 
appropriate therapy.
    (b) Classification. Class II.



Sec. 862.3645  Neuroleptic drugs radioreceptor assay test system.

    (a) Identification. A neuroleptic drugs radioceptor assay test 
system is a device intended to measure in serum or plasma the dopamine 
receptor blocking activity of neuroleptic drugs and their active 
metabolites. A neuroleptic drug has anti-psychotic action affecting 
principally psychomotor activity, is generally without hypnotic effects, 
and is a tranquilizer. Measurements obtained by this device are used to 
aid in determining whether a patient is taking the prescribed dosage 
level of such drugs.
    (b) Classification. Class II.



Sec. 862.3650  Opiate test system.

    (a) Identification. An opiate test system is a device intended to 
measure any of the addictive narcotic pain-relieving opiate drugs in 
blood, serum, urine, gastric contents, and saliva. An opiate is any 
natural or synthetic drug that has morphine-like pharmocological 
actions. The opiates include drugs such as morphine, morphine 
glucoronide, heroin, codeine, nalorphine, and meperedine. Measurements 
obtained by this device are used

[[Page 208]]

in the diagnosis and treatment of opiate use or overdose and in 
monitoring the levels of opiate administration to ensure appropriate 
therapy.
    (b) Classification. Class II.



Sec. 862.3660  Phenobarbital test system.

    (a) Identification. A phenobarbitol test system is a device intended 
to measure phenobarbital, an antiepileptic and sedative-hypnotic drug, 
in human specimens. Measurements obtained by this device are used in the 
diagnosis and treatment of phenobarbital use or overdose and in 
monitoring levels of phenobarbital to ensure appropriate therapy.
    (b) Classification. Class II.



Sec. 862.3670  Phenothiazine test system.

    (a) Identification. A phenothiazine test system is a device intended 
to measure any of the drugs of the phenothiazine class in human 
specimens. Measurements obtained by this device are used in the 
diagnosis and treatment of phenothiazine use or overdose.
    (b) Classification. Class II.



Sec. 862.3680  Primidone test system.

    (a) Identification. A primidone test system is a device intended to 
measure primidone, an antiepileptic drug, in human specimens. 
Measurements obtained by this device are used in the diagnosis and 
treatment of primidone overdose and in monitoring levels of primidone to 
ensure appropriate therapy.
    (b) Classification. Class II.



Sec. 862.3700  Propoxyphene test system.

    (a) Identification. A propoxyphene test system is a device intended 
to measure propoxyphene, a pain-relieving drug, in serum, plasma, and 
urine. Measurements obtained by this device are used in the diagnosis 
and treatment of propoxyphene use or overdose or in monitoring levels of 
propoxyphene to ensure appropriate therapy.
    (b) Classification. Class II.



Sec. 862.3750  Quinine test system.

    (a) Identification. A quinine test system is a device intended to 
measure quinine, a fever-reducing and pain-relieving drug intended in 
the treatment of malaria, in serum and urine. Measurements obtained by 
this device are used in the diagnosis and treatment of quinine overdose 
and malaria.
    (b) Classification. Class I.

[52 FR 16122, May 1, 1987, as amended at 53 FR 21450, June 8, 1988; 65 
FR 2310, Jan. 14, 2000]



Sec. 862.3830  Salicylate test system.

    (a) Identification. A salicylate test system is a device intended to 
measure salicylates, a class of analgesic, antipyretic and anti-
inflammatory drugs that includes aspirin, in human specimens. 
Measurements obtained by this device are used in diagnosis and treatment 
of salicylate overdose and in monitoring salicylate levels to ensure 
appropriate therapy.
    (b) Classification. Class II.



Sec. 862.3850  Sulfonamide test system.

    (a) Identification. A sulfonamide test system is a device intended 
to measure sulfonamides, any of the antibacterial drugs derived from 
sulfanilamide, in human specimens. Measurements obtained by this device 
are used in the diagnosis and treatment of sulfonamide overdose and in 
monitoring sulfonamide levels to ensure appropriate therapy.
    (b) Classification. Class I.

[52 FR 16122, May 1, 1987, as amended at 53 FR 21450, June 8, 1988; 65 
FR 2310, Jan. 14, 2000]



Sec. 862.3870  Cannabinoid test system.

    (a) Identification. A cannabinoid test system is a device intended 
to measure any of the cannabinoids, hallucinogenic compounds endogenous 
to marihuana, in serum, plasma, saliva, and urine. Cannabinoid compounds 
include delta-9-tetrahydrocannabinol, cannabidiol, cannabinol, and 
cannabichromene. Measurements obtained by this device are used in the 
diagnosis and treatment of cannabinoid use or abuse and in monitoring 
levels of cannabinoids during clinical investigational use.
    (b) Classification. Class II.

[[Page 209]]



Sec. 862.3880  Theophylline test system.

    (a) Identification. A theophylline test system is a device intended 
to measure theophylline (a drug used for stimulation of the muscles in 
the cardiovascular, respiratory, and central nervous systems) in serum 
and plasma. Measurements obtained by this device are used in the 
diagnosis and treatment of theophylline overdose or in monitoring levels 
of theophylline to ensure appropriate therapy.
    (b) Classification. Class II.



Sec. 862.3900  Tobramycin test system.

    (a) Identification. A tobramycin test system is a device intended to 
measure tobramycin, an aminoglycoside antibiotic drug, in plasma and 
serum. Measurements obtained by this device are used in the diagnosis 
and treatment of tobramycin overdose and in monitoring levels of 
tobramycin to ensure appropriate therapy.
    (b) Classification. Class II.



Sec. 862.3910  Tricyclic antidepressant drugs test system.

    (a) Identification. A tricyclic antidepressant drugs test system is 
a device intended to measure any of the tricyclic antidepressant drugs 
in serum. The tricyclic antidepressant drugs include imipramine, 
desipramine, amitriptyline, nortriptyline, protriptyline, and doxepin. 
Measurements obtained by this device are used in the diagnosis and 
treatment of chronic depression to ensure appropriate therapy.
    (b) Classification. Class II.



Sec. 862.3950  Vancomycin test system.

    (a) Identification. A vancomycin test system is a device intended to 
measure vancomycin, an antibiotic drug, in serum. Measurements obtained 
by this device are used in the diagnosis and treatment of vancomycin 
overdose and in monitoring the level of vancomycin to ensure appropriate 
therapy.
    (b) Classification. Class II.



PART 864--HEMATOLOGY AND PATHOLOGY DEVICES--Table of Contents




                      Subpart A--General Provisions

Sec.
864.1  Scope.
864.3  Effective dates of requirement for premarket approval.
864.9  Limitations of exemptions from section 510(k) of the Federal 
          Food, Drug, and Cosmetic Act (the act).

                      Subpart B--Biological Stains

864.1850  Dye and chemical solution stains.
864.1860  Immunohistochemistry reagents and kits.

               Subpart C--Cell and Tissue Culture Products

864.2220  Synthetic cell and tissue culture media and components.
864.2240  Cell and tissue culture supplies and equipment.
864.2260  Chromosome culture kit.
864.2280  Cultured animal and human cells.
864.2360  Mycoplasma detection media and components.
864.2800  Animal and human sera.
864.2875  Balanced salt solutions or formulations.

          Subpart D--Pathology Instrumentation and Accessories

864.3010  Tissue processing equipment.
864.3250  Specimen transport and storage container.
864.3300  Cytocentrifuge.
864.3400  Device for sealing microsections.
864.3600  Microscopes and accessories.
864.3800  Automated slide stainer.
864.3875  Automated tissue processor.

                Subpart E--Specimen Preparation Reagents

864.4010  General purpose reagent.
864.4020  Analyte specific reagents.
864.4400  Enzyme preparations.

       Subpart F--Automated and Semi-Automated Hematology Devices

864.5200  Automated cell counter.
864.5220  Automated differential cell counter.
864.5240  Automated blood cell diluting apparatus.
864.5260  Automated cell-locating device.
864.5300  Red cell indices device.

[[Page 210]]

864.5350  Microsedimentation centrifuge.
864.5400  Coagulation instrument.
864.5425  Multipurpose system for in vitro coagulation studies.
864.5600  Automated hematocrit instrument.
864.5620  Automated hemoglobin system.
864.5680  Automated heparin analyzer.
864.5700  Automated platelet aggregation system.
864.5800  Automated sedimentation rate device.
864.5850  Automated slide spinner.
864.5950  Blood volume measuring device.

                  Subpart G--Manual Hematology Devices

864.6100  Bleeding time device.
864.6150  Capillary blood collection tube.
864.6160  Manual blood cell counting device.
864.6400  Hematocrit measuring device.
864.6550  Occult blood test.
864.6600  Osmotic fragility test.
864.6650  Platelet adhesion test.
864.6675  Platelet aggregometer.
864.6700  Erythrocyte sedimentation rate test.

                 Subpart H--Hematology Kits and Packages

864.7040  Adenosine triphosphate release assay.
864.7060  Antithrombin III assay.
864.7100  Red blood cell enzyme assay.
864.7140  Activated whole blood clotting time tests.
864.7250  Erythropoietin assay.
864.7275  Euglobulin lysis time tests.
864.7290  Factor deficiency test.
864.7300  Fibrin monomer paracoagulation test.
864.7320  Fibrinogen/fibrin degradation products assay.
864.7340  Fibrinogen determination system.
864.7360  Erythrocytic glucose-6-phosphate dehydrogenase assay.
864.7375  Glutathione reductase assay.
864.7400  Hemoglobin A2 assay.
864.7415  Abnormal hemoglobin assay.
864.7425  Carboxyhemoglobin assay.
864.7440  Electrophoretic hemoglobin analysis system.
864.7455  Fetal hemoglobin assay.
864.7470  Glycosylated hemoglobin assay.
864.7490  Sulfhemoglobin assay.
864.7500  Whole blood hemoglobin assays.
864.7525  Heparin assay.
864.7660  Leukocyte alkaline phosphatase test.
864.7675  Leukocyte peroxidase test.
864.7695  Platelet factor 4 radioimmunoassay.
864.7720  Prothrombin consumption test.
864.7735  Prothrombin-proconvertin test and thrombotest.
864.7750  Prothrombin time test.
864.7825  Sickle cell test.
864.7875  Thrombin time test.
864.7900  Thromboplastin generation test.
864.7925  Partial thromboplastin time tests.

                     Subpart I--Hematology Reagents

864.8100  Bothrops atrox reagent.
864.8150  Calibrator for cell indices.
864.8165  Calibrator for hemoglobin or hematocrit measurement.
864.8175  Calibrator for platelet counting.
864.8185  Calibrator for red cell and white cell counting.
864.8200  Blood cell diluent.
864.8500  Lymphocyte separation medium.
864.8540  Red cell lysing reagent.
864.8625  Hematology quality control mixture.
864.8950  Russell viper venom reagent.

 Subpart J--Products Used In Establishments That Manufacture Blood and 
                             Blood Products

864.9050  Blood bank supplies.
864.9100  Empty container for the collection and processing of blood and 
          blood components.
864.9125  Vacuum-assisted blood collection system.
864.9145  Processing system for frozen blood.
864.9160  Blood group substances of nonhuman origin for in vitro 
          diagnostic use.
864.9175  Automated blood grouping and antibody test system.
864.9185  Blood grouping view box.
864.9195  Blood mixing devices and blood weighing devices.
864.9205  Blood and plasma warming device.
864.9225  Cell-freezing apparatus and reagents for in vitro diagnostic 
          use.
864.9245  Automated blood cell separator.
864.9275  Blood bank centrifuge for in vitro diagnostic use.
864.9285  Automated cell-washing centrifuge for immuno-hematology.
864.9300  Automated Coombs test systems.
864.9320  Copper sulfate solution for specific gravity determinations.
864.9400  Stabilized enzyme solution.
864.9550  Lectins and protectins.
864.9575  Environmental chamber for storage of platelet concentrate.
864.9600  Potentiating media for in vitro diagnostic use.
864.9650  Quality control kit for blood banking reagents.
864.9700  Blood storage refrigerator and blood storage freezer.
864.9750  Heat-sealing device.
864.9875  Transfer set.

    Authority: 21 U.S.C. 351, 360, 360c, 360e, 360j, 371.

[[Page 211]]



                      Subpart A--General Provisions



Sec. 864.1  Scope.

    (a) This part sets forth the classification of hematology and 
pathology devices intended for human use that are in commercial 
distribution.
    (b) The identification of a device in a regulation in this part is 
not a precise description of every device that is, or will be, subject 
to the regulation. A manufacturer who submits a premarket notification 
submission for a device under part 807 may not show merely that the 
device is accurately described by the section title and identification 
provisions of a regulation in this part, but shall state why the device 
is substantially equivalent to other devices, as required by 
Sec. 807.87.
    (c) References in this part to regulatory sections of the Code of 
Federal Regulations are to chapter I of title 21, unless otherwise 
noted.

[52 FR 17732, May 11, 1987]



Sec. 864.3  Effective dates of requirement for premarket approval.

    A device included in this part that is classified into class III 
(premarket approval) shall not be commercially distributed after the 
date shown in the regulation classifying the device unless the 
manufacturer has an approval under section 515 of the act (unless an 
exemption has been granted under section 520(g)(2) of the act). An 
approval under section 515 of the act consists of FDA's issuance of an 
order approving an application for premarket approval (PMA) for the 
device or declaring completed a product development protocol (PDP) for 
the device.
    (a) Before FDA requires that a device commercially distributed 
before the enactment date of the amendments, or a device that has been 
found substantially equivalent to such a device, has an approval under 
section 515 of the act FDA must promulgate a regulation under section 
515(b) of the act requiring such approval, except as provided in 
paragraph (b) of this section. Such a regulation under section 515(b) of 
the act shall not be effective during the grace period ending on the 
90th day after its promulgation or on the last day of the 30th full 
calendar month after the regulation that classifies the device into 
class III is effective, whichever is later. See section 501(f)(2)(B) of 
the act. Accordingly, unless an effective date of the requirement for 
premarket approval is shown in the regulation for a device classified 
into class III in this part, the device may be commercially distributed 
without FDA's issuance of an order approving a PMA or declaring 
completed a PDP for the device. If FDA promulgates a regulation under 
section 515(b) of the act requiring premarket approval for a device, 
section 501(f)(1)(A) of the act applies to the device.
    (b) Any new, not substantially equivalent, device introduced into 
commercial distribution on or after May 28, 1976, including a device 
formerly marketed that has been substantially altered, is classified by 
statute (section 513(f) of the act) into class III without any grace 
period and FDA must have issued an order approving a PMA or declaring 
completed a PDP for the device before the device is commercially 
distributed unless it is reclassified. If FDA knows that a device being 
commercially distributed may be a ``new'' device as defined in this 
section because of any new intended use or other reasons, FDA may codify 
the statutory classification of the device into class III for such new 
use. Accordingly, the regulation for such a class III device states that 
as of the enactment date of the amendments, May 28, 1976, the device 
must have an approval under section 515 of the act before commercial 
distribution.

[52 FR 17732, May 11, 1987]



Sec. 864.9  Limitations of exemptions from section 510(k) of the Federal Food, Drug, and Cosmetic Act (the act).

    The exemption from the requirement of premarket notification 
(section 510(k) of the act) for a generic type of class I or II device 
is only to the extent that the device has existing or reasonably 
foreseeable characteristics of commercially distributed devices within 
that generic type or, in the case of in vitro diagnostic devices, only 
to the extent that misdiagnosis as a result of using the device would 
not be associated with high morbidity or mortality. Accordingly, 
manufacturers of any

[[Page 212]]

commercially distributed class I or II device for which FDA has granted 
an exemption from the requirement of premarket notification must still 
submit a premarket notification to FDA before introducing or delivering 
for introduction into interstate commerce for commercial distribution 
the device when:
    (a) The device is intended for a use different from the intended use 
of a legally marketed device in that generic type of device; e.g., the 
device is intended for a different medical purpose, or the device is 
intended for lay use where the former intended use was by health care 
professionals only;
    (b) The modified device operates using a different fundamental 
scientific technology than a legally marketed device in that generic 
type of device; e.g., a surgical instrument cuts tissue with a laser 
beam rather than with a sharpened metal blade, or an in vitro diagnostic 
device detects or identifies infectious agents by using deoxyribonucleic 
acid (DNA) probe or nucleic acid hybridization technology rather than 
culture or immunoassay technology; or
    (c) The device is an in vitro device that is intended:
    (1) For use in the diagnosis, monitoring, or screening of neoplastic 
diseases with the exception of immunohistochemical devices;
    (2) For use in screening or diagnosis of familial or acquired 
genetic disorders, including inborn errors of metabolism;
    (3) For measuring an analyte that serves as a surrogate marker for 
screening, diagnosis, or monitoring life-threatening diseases such as 
acquired immune deficiency syndrome (AIDS), chronic or active hepatitis, 
tuberculosis, or myocardial infarction or to monitor therapy;
    (4) For assessing the risk of cardiovascular diseases;
    (5) For use in diabetes management;
    (6) For identifying or inferring the identity of a microorganism 
directly from clinical material;
    (7) For detection of antibodies to microorganisms other than 
immunoglobulin G (IgG) or IgG assays when the results are not 
qualitative, or are used to determine immunity, or the assay is intended 
for use in matrices other than serum or plasma;
    (8) For noninvasive testing as defined in Sec. 812.3(k) of this 
chapter; and
    (9) For near patient testing (point of care).

[65 FR 2310, Jan. 14, 2000]



                      Subpart B--Biological Stains



Sec. 864.1850  Dye and chemical solution stains.

    (a) Identification. Dye and chemical solution stains for medical 
purposes are mixtures of synthetic or natural dyes or nondye chemicals 
in solutions used in staining cells and tissues for diagnostic 
histopathology, cytopathology, or hematology.
    (b) Classification. Class I. These devices are exempt from the 
premarket notification procedures in subpart E of part 807. The devices 
are also exempt from the current good manufacturing practice regulations 
in part 820 of this chapter, with the exception of Sec. 820.180, with 
respect to general requirements concerning records, and Sec. 820.198, 
with respect to complaint files.

[45 FR 60583, Sept. 12, 1980, as amended at 54 FR 25044, June 12, 1989]



Sec. 864.1860  Immunohistochemistry reagents and kits.

    (a) Identification. Immunohistochemistry test systems (IHC's) are in 
vitro diagnostic devices consisting of polyclonal or monoclonal 
antibodies labeled with directions for use and performance claims, which 
may be packaged with ancillary reagents in kits. Their intended use is 
to identify, by immunological techniques, antigens in tissues or 
cytologic specimens. Similar devices intended for use with flow 
cytometry devices are not considered IHC's.
    (b) Classification of immunohistochemistry devices. (1) Class I 
(general controls). Except as described in paragraphs (b)(2) and (b)(3) 
of this section, these devices are exempt from the premarket 
notification requirements in part 807, subpart E of this chapter. This 
exemption applies to IHC's that provide the pathologist with adjunctive 
diagnostic information that

[[Page 213]]

may be incorporated into the pathologist's report, but that is not 
ordinarily reported to the clinician as an independent finding. These 
IHC's are used after the primary diagnosis of tumor (neoplasm) has been 
made by conventional histopathology using nonimmunologic histochemical 
stains, such as hematoxylin and eosin. Examples of class I IHC's are 
differentiation markers that are used as adjunctive tests to subclassify 
tumors, such as keratin.
    (2) Class II (special control, guidance document: ``FDA Guidance for 
Submission of Immunohistochemistry Applications to the FDA,'' Center for 
Devices and Radiologic Health, 1998). These IHC's are intended for the 
detection and/or measurement of certain target analytes in order to 
provide prognostic or predictive data that are not directly confirmed by 
routine histopathologic internal and external control specimens. These 
IHC's provide the pathologist with information that is ordinarily 
reported as independent diagnostic information to the ordering 
clinician, and the claims associated with these data are widely accepted 
and supported by valid scientific evidence. Examples of class II IHC's 
are those intended for semiquantitative measurement of an analyte, such 
as hormone receptors in breast cancer.
    (3) Class III (premarket approval). IHC's intended for any use not 
described in paragraphs (b)(1) or (b)(2) of this section.
    (c) Date of PMA or notice of completion of a PDP is required. As of 
May 28, 1976, an approval under section 515 of the Federal Food, Drug, 
and Cosmetic Act is required for any device described in paragraph 
(b)(3) of this section before this device may be commercially 
distributed. See Sec. 864.3.

[63 FR 30142, June 3, 1998]



               Subpart C--Cell And Tissue Culture Products



Sec. 864.2220  Synthetic cell and tissue culture media and components.

    (a) Identification. Synthetic cell and tissue culture media and 
components are substances that are composed entirely of defined 
components (e.g., amino acids, vitamins, inorganic salts, etc.) that are 
essential for the survival and development of cell lines of humans and 
other animals.
    (b) Classification. Class I. These devices are exempt from the 
premarket notification procedures in subpart E of part 807 of this 
chapter.

[45 FR 60583, Sept. 12, 1980, as amended at 54 FR 25044, June 12, 1989]



Sec. 864.2240  Cell and tissue culture supplies and equipment.

    (a) Identification. Cell and tissue culture supplies and equipment 
are devices that are used to examine, propagate, nourish, or grow cells 
and tissue cultures. These include such articles as slide culture 
chambers, perfusion and roller apparatus, cell culture suspension 
systems, and tissue culture flasks, disks, tubes, and roller bottles.
    (b) Classification. Class I. These devices are exempt from the 
premarket notification procedures in subpart E of part 807 of this 
chapter. If the devices are not labeled or otherwise represented as 
sterile, they are exempt from the current good manufacturing practice 
regulations in part 820 of this chapter, with the exception of 
Sec. 820.180, with respect to general requirements concerning records, 
and Sec. 820.198, with respect to complaint files.

[45 FR 60584, Sept. 12, 1980, as amended at 54 FR 25044, June 12, 1989]



Sec. 864.2260  Chromosome culture kit.

    (a) Identification. A chromosome culture kit is a device containing 
the necessary ingredients (e.g., Minimum Essential Media (MEM) of 
McCoy's 5A culture media, phytohemagglutinin, fetal calf serum, 
antibiotics, and heparin) used to culture tissues for diagnosis of 
congenital chromosome abnormalities.
    (b) Classification. Class I. The device is exempt from the premarket 
notification procedures in subpart E of part 807 of this chapter.

[45 FR 60585, Sept. 12, 1980, as amended at 54 FR 25044, June 12, 1989]



Sec. 864.2280  Cultured animal and human cells.

    (a) Identification. Cultured animal and human cells are in vitro 
cultivated

[[Page 214]]

cell lines from the tissue of humans or other animals which are used in 
various diagnostic procedures, particularly diagnostic virology and 
cytogenetic studies.
    (b) Classification. Class I (general controls). The device is exempt 
from the premarket notification procedures in subpart E of part 807 of 
this chapter subject to Sec. 864.9.

[45 FR 60585, Sept. 12, 1980, as amended at 65 FR 2310, Jan. 14, 2000]



Sec. 864.2360  Mycoplasma detection media and components.

    (a) Identification. Mycoplasma detection media and components are 
used to detect and isolate mycoplasma pleuropneumonia-like organisms 
(PPLO), a common microbial contaminant in cell cultures.
    (b) Classification. Class I. These devices are exempt from the 
premarket notification procedures in subpart E of part 807 of this 
chapter.

[45 FR 60586, Sept. 12, 1980, as amended at 54 FR 25044, June 12, 1989]



Sec. 864.2800  Animal and human sera.

    (a) Identification. Animal and human sera are biological products, 
obtained from the blood of humans or other animals, that provide the 
necessary growth-promoting nutrients in a cell culture system.
    (b) Classification. Class I. The devices are exempt from the 
premarket notification procedures in subpart E of part 807 of this 
chapter.

[45 FR 60586, Sept. 12, 1980, as amended at 54 FR 25044, June 12, 1989]



Sec. 864.2875  Balanced salt solutions or formulations.

    (a) Identification. A balanced salt solution or formulation is a 
defined mixture of salts and glucose in a simple medium. This device is 
included as a necessary component of most cell culture systems. This 
media component controls for pH, osmotic pressure, energy source, and 
inorganic ions.
    (b) Classification. Class I. These devices are exempt from the 
premarket notification procedures in subpart E of part 807 of this 
chapter.

[45 FR 60586, Sept. 12, 1980, as amended at 54 FR 25044, June 12, 1989]



          Subpart D--Pathology Instrumentation and Accessories



Sec. 864.3010  Tissue processing equipment.

    (a) Identification. Tissue processing equipment consists of devices 
used to prepare human tissue specimens for diagnostic histological 
examination by processing specimens through the various stages of 
decalcifying, infiltrating, sectioning, and mounting on microscope 
slides.
    (b) Classification. Class I. The device is exempt from the premarket 
notification procedures in subpart E of part 807 of this chapter. The 
device is also exempt from the current good manufacturing practice 
regulations in part 820 of this chapter, with the exception of 
Sec. 820.180, with respect to general requirements concerning records, 
and Sec. 820.198, with respect to complaint files.

[45 FR 60587, Sept. 12, 1980, as amended at 54 FR 25044, June 12, 1989]



Sec. 864.3250  Specimen transport and storage container.

    (a) Identification. A specimen transport and storage container, 
which may be empty or prefilled, is a device intended to contain 
biological specimens, body waste, or body exudate during storage and 
transport in order that the matter contained therein can be destroyed or 
used effectively for diagnostic examination. If prefilled, the device 
contains a fixative solution or other general purpose reagent to 
preserve the condition of a biological specimen added to the container.
    (b) Classification. Class I (general controls). The device is exempt 
from the premarket notification procedures in subpart E of part 807 of 
this chapter subject to Sec. 864.9. If the device is not labeled or 
otherwise represented as sterile, it is exempt from the current good 
manufacturing practice regulations in part 820 of this chapter, with the 
exception of Sec. 820.180 of this chapter, with respect to general 
requirements concerning records, and Sec. 820.198 of this chapter, with 
respect to complaint files.

[54 FR 47206, Nov. 13, 1989, as amended at 65 FR 2310, Jan. 14, 2000]

[[Page 215]]



Sec. 864.3300  Cytocentrifuge.

    (a) Identification. A cytocentrifuge is a centrifuge used to 
concentrate cells from biological cell suspensions (e.g., cerebrospinal 
fluid) and to deposit these cells on a glass microscope slide for 
cytological examination.
    (b) Classification. Class I. The device is exempt from the premarket 
notification procedures in subpart E of part 807 of this chapter.

[45 FR 60588, Sept. 12, 1980, as amended at 54 FR 25044, June 12, 1989]



Sec. 864.3400  Device for sealing microsections.

    (a) Identification. A device for sealing microsections is an 
automated instrument used to seal stained cells and microsections for 
histological and cytological examination.
    (b) Classification. Class I. The device is exempt from the premarket 
notification procedures in subpart E of part 807 of this chapter.

[45 FR 60589, Sept. 12, 1980, as amended at 54 FR 25044, June 12, 1989]



Sec. 864.3600  Microscopes and accessories.

    (a) Identification. Microscopes and accessories are optical 
instruments used to enlarge images of specimens, preparations, and 
cultures for medical purposes. Variations of microscopes and accessories 
(through a change in the light source) used for medical purposes include 
the following:
    (1) Phase contrast microscopes, which permit visualization of 
unstained preparations by altering the phase relationship of light that 
passes around the object and through the object.
    (2) Fluorescense microscopes, which permit examination of specimens 
stained with fluorochromes that fluoresce under ultraviolet light.
    (3) Inverted stage microscopes, which permit examination of tissue 
cultures or other biological specimens contained in bottles or tubes 
with the light source mounted above the specimen.
    (b) Classification. Class I. These devices are exempt from the 
premarket notification procedures in subpart E of part 807 of this 
chapter. The devices are also exempt from the current good manufacturing 
practice regulations in part 820 of this chapter, with the exception of 
Sec. 820.180, with respect to general requirements concerning records, 
and Sec. 820.198, with respect to complaint files.

[45 FR 60590, Sept. 12, 1980, as amended at 54 FR 25044, June 12, 1989]



Sec. 864.3800  Automated slide stainer.

    (a) Identification. An automated slide stainer is a device used to 
stain histology, cytology, and hematology slides for diagnosis.
    (b) Classification. Class I. The device is exempt from the premarket 
notification procedures in subpart E of part 807 of this chapter.

[45 FR 60591, Sept. 12, 1980, as amended at 54 FR 25044, June 12, 1989]



Sec. 864.3875  Automated tissue processor.

    (a) Identification. An automated tissue processor is an automated 
system used to process tissue specimens for examination through 
fixation, dehydration, and infiltration.
    (b) Classification. Class I. The device is exempt from the premarket 
notification procedures in subpart E of part 807 of this chapter.

[45 FR 60591, Sept. 12, 1980, as amended at 54 FR 25045, June 12, 1989]



                Subpart E--Specimen Preparation Reagents



Sec. 864.4010  General purpose reagent.

    (a) A general purpose reagent is a chemical reagent that has general 
laboratory application, that is used to collect, prepare, and examine 
specimens from the human body for diagnostic purposes, and that is not 
labeled or otherwise intended for a specific diagnostic application. It 
may be either an individual substance, or multiple substances 
reformulated, which, when combined with or used in conjunction with an 
appropriate analyte specific reagent (ASR) and other general purpose 
reagents, is part of a diagnostic test procedure or system constituting 
a finished in vitro diagnostic (IVD) test. General purpose reagents are 
appropriate for combining with one or more

[[Page 216]]

than one ASR in producing such systems and include labware or disposable 
constituents of tests; but they do not include laboratory machinery, 
automated or powered systems. General purpose reagents include 
cytological preservatives, decalcifying reagents, fixative and 
adhesives, tissue processing reagents, isotonic solutions and pH 
buffers. Reagents used in tests for more than one individual chemical 
substance or ligand are general purpose reagents (e.g., Thermus 
aquaticus (TAQ) polymerase, substrates for enzyme immunoassay (EIA)).
    (b) Classification. Class I. The device is exempt from the premarket 
notification procedures in subpart E of part 807 of this chapter. If the 
device is not labeled or otherwise represented as sterile, it is exempt 
from the current good manufacturing practice regulations in part 820 of 
this chapter, with the exception of Sec. 820.180, with respect to 
general requirements concerning records, and Sec. 820.198, with respect 
to complaint files.

[45 FR 60592, Sept. 12, 1980, as amended at 54 FR 25045, June 12, 1989; 
62 FR 62260, Nov. 21, 1997]



Sec. 864.4020  Analyte specific reagents.

    (a) Identification. Analyte specific reagents (ASR's) are 
antibodies, both polyclonal and monoclonal, specific receptor proteins, 
ligands, nucleic acid sequences, and similar reagents which, through 
specific binding or chemical reaction with substances in a specimen, are 
intended for use in a diagnostic application for identification and 
quantification of an individual chemical substance or ligand in 
biological specimens. ASR's that otherwise fall within this definition 
are not within the scope of subpart E of this part when they are sold 
to:
    (1) In vitro diagnostic manufacturers; or
    (2) Organizations that use the reagents to make tests for purposes 
other than providing diagnostic information to patients and 
practitioners, e.g., forensic, academic, research, and other nonclinical 
laboratories.
    (b) Classification. (1) Class I (general controls). Except as 
described in paragraphs (b)(2) and (b)(3) of this section, these devices 
are exempt from the premarket notification requirements in part 807, 
subpart E of this chapter.
    (2) Class II (special controls/guidance documents), when the analyte 
is used in blood banking tests that have been classified as class II 
devices (e.g., certain cytomegalovirus serological and treponema 
pallidum nontreponemal test reagents). Guidance Documents:

    1. ``Specifications for Immunological Testing for Infectious 
Disease; Approved Guideline,'' NCCLS Document I/LA18-A, December 1994.
    2. ``Assessment of the Clinical Accuracy of Laboratory Tests Using 
Receiver Operating Characteristic (ROC) Plots; Tentative Guideline,'' 
NCCLS Document KGP10-T, December 1993.
    3. ``Review Criteria for Assessment of In Vitro Diagnostic Devices 
for Direct Detection of Mycobacterium spp,'' FDA, July 6, 1993, and its 
``Attachment 1,'' February 28, 1994.
    4. ``Draft Review Criteria for Nucleic Acid Amplification-Based In 
Vitro Diagnostic Devices for Direct Detection of Infectious 
Microorganisms,'' FDA, July 6, 1993.
    5. The Center for Biologics Evaluation and Research, FDA, ``Points 
to Consider in the Manufacture and Clinical Evaluation of In Vitro Tests 
to Detect Antibodies to the Human Immunodeficiency Virus, Type I'' (54 
FR 48943, November 28, 1989).

    (3) Class III (premarket approval), when:
    (i) The analyte is intended as a component in a test intended for 
use in the diagnosis of a contagious condition that is highly likely to 
result in a fatal outcome and prompt, accurate diagnosis offers the 
opportunity to mitigate the public health impact of the condition (e.g., 
human immunodeficiency virus (HIV/AIDS)or tuberculosis (TB)); or
    (ii) The analyte is intended as a component in a test intended for 
use in donor screening for conditions for which FDA has recommended or 
required testing in order to safeguard the blood supply or establish the 
safe use of blood and blood products (e.g., tests for hepatitis or tests 
for identifying blood groups).
    (c) Date of 510(k), or date of PMA or notice of completion of a 
product development protocol is required. (1) Preamendments ASR's; No 
effective date has been established for the requirement for premarket 
approval for

[[Page 217]]

the device described in paragraph (b)(3) of this section. See 
Sec. 864.3.
    (2) For postamendments ASR's; November 23, 1998.
    (d) Restrictions. Restrictions on the sale, distribution and use of 
ASR's are set forth in Sec. 809.30 of this chapter.

[62 FR 62260, Nov. 21, 1997]



Sec. 864.4400  Enzyme preparations.

    (a) Identification. Enzyme preparations are products that are used 
in the histopathology laboratory for the following purposes:
    (1) To disaggregate tissues and cells already in established 
cultures for preparation into subsequent cultures (e.g., trypsin);
    (2) To disaggregate fluid specimens for cytological examination 
(e.g., papain for gastric lavage or trypsin for sputum liquefaction);
    (3) To aid in the selective staining of tissue specimens (e.g., 
diastase for glycogen determination).
    (b) Classification. Class I. These devices are exempt from the 
premarket notification procedures in subpart E of part 807 of this 
chapter.

[45 FR 60592, Sept. 12, 1980, as amended at 54 FR 25045, June 12, 1989]



       Subpart F--Automated and Semi-Automated Hematology Devices



Sec. 864.5200  Automated cell counter.

    (a) Identification. An automated cell counter is a fully-automated 
or semi-automated device used to count red blood cells, white blood 
cells, or blood platelets using a sample of the patient's peripheral 
blood (blood circulating in one of the body's extremities, such as the 
arm). These devices may also measure hemoglobin or hematocrit and may 
also calculate or measure one or more of the red cell indices (the 
erythrocyte mean corpuscular volume, the mean corpuscular hemoglobin, or 
the mean corpuscular hemoglobin concentration). These devices may use 
either an electronic particle counting method or an optical counting 
method.
    (b) Classification. Class II (performance standards).

[45 FR 60593, Sept. 12, 1980]



Sec. 864.5220  Automated differential cell counter.

    (a) Identification. An automated differential cell counter is a 
device used to identify and classify one or more of the formed elements 
of the blood.
    (b) Classification. (1) Class II (performance standards) when the 
device is intended to flag or identify specimens containing abnormal 
blood cells.
    (2) Class III (premarket approval) when the device is intended for 
other uses, including to count or classify abnormal cells of the blood.
    (c) Date PMA or notice of completion of a PDP is required. No 
effective date has been established of the requirement for premarket 
approval for the device identified in paragraph (b)(2) of this section. 
See Sec. 864.3.

[45 FR 60596, Sept. 12, 1980, as amended at 55 FR 23511, June 8, 1990]



Sec. 864.5240  Automated blood cell diluting apparatus.

    (a) Identification. An automated blood cell diluting apparatus is a 
fully automated or semi-automated device used to make appropriate 
dilutions of a blood sample for further testing.
    (b) Classification. Class I (general controls). The device is exempt 
from the premarket notification procedures in subpart E of part 807 of 
this chapter subject to Sec. 864.9.

[45 FR 60596, Sept. 12, 1980, as amended at 65 FR 2310, Jan. 14, 2000]



Sec. 864.5260  Automated cell-locating device.

    (a) Identification. An automated cell-locating device is a device 
used to locate blood cells on a peripheral blood smear, allowing the 
operator to identify and classify each cell according to type. 
(Peripheral blood is blood circulating in one of the body's extremities, 
such as the arm.)
    (b) Classification. Class II (performance standards).

[45 FR 60597, Sept. 12, 1980]



Sec. 864.5300  Red cell indices device.

    (a) Identification. A red cell indices device, usually part of a 
larger system, calculates or directly measures the erythrocyte mean 
corpuscular volume

[[Page 218]]

(MCV), the mean corpuscular hemoglobin (MCH), and the mean corpuscular 
hemoglobin concentration (MCHC). The red cell indices are used for the 
differential diagnosis of anemias.
    (b) Classification. Class II (performance standards).

[45 FR 60597, Sept. 12, 1980]



Sec. 864.5350  Microsedimentation centrifuge.

    (a) Identification. A microsedimentation centrifuge is a device used 
to sediment red cells for the microsedimentation rate test.
    (b) Classification. Class I. The device is exempt from the premarket 
notification procedures in subpart E of part 807 of this chapter.

[45 FR 60598, Sept. 12, 1980, as amended at 59 FR 63007, Dec. 7, 1994]



Sec. 864.5400  Coagulation instrument.

    (a) Identification. A coagulation instrument is an automated or 
semiautomated device used to determine the onset of clot formation for 
in vitro coagulation studies.
    (b) Classification. Class II (performance standards).

[45 FR 60598, Sept. 12, 1980]



Sec. 864.5425  Multipurpose system for in vitro coagulation studies.

    (a) Identification. A multipurpose system for in vitro coagulation 
studies is a device consisting of one automated or semiautomated 
instrument and its associated reagents and controls. The system is used 
to perform a series of coagulation studies and coagulation factor 
assays.
    (b) Classification. Class II (performance standards).

[45 FR 60599, Sept. 12, 1980]



Sec. 864.5600  Automated hematocrit instrument.

    (a) Identification. An automated hematocrit instrument is a fully 
automated or semi-automated device which may or may not be part of a 
larger system. This device measures the packed red cell volume of a 
blood sample to distinguish normal from abnormal states, such as anemia 
and erythrocytosis (an increase in the number of red cells).
    (b) Classification. Class II (performance standards).

[45 FR 60600, Sept. 12, 1980]



Sec. 864.5620  Automated hemoglobin system.

    (a) Identification. An automated hemoglobin system is a fully 
automated or semi-automated device which may or may not be part of a 
larger system. The generic type of device consists of the reagents, 
calibrators, controls, and instrumentation used to determine the 
hemoglobin content of human blood.
    (b) Classification. Class II (performance standards).

[45 FR 60601, Sept. 12, 1980]



Sec. 864.5680  Automated heparin analyzer.

    (a) Identification. An automated heparin analyzer is a device used 
to determine the heparin level in a blood sample by mixing the sample 
with protamine (a heparin-neutralizing substance) and determining 
photometrically the onset of air-activated clotting. The analyzer also 
determines the amount of protamine necessary to neutralize the heparin 
in the patient's circulation.
    (b) Classification. Class II (special controls).

[45 FR 60601, Sept. 12, 1980, as amended at 52 FR 17733, May 11, 1987; 
58 FR 51571, Oct. 4, 1993]



Sec. 864.5700  Automated platelet aggregation system.

    (a) Identification. An automated platelet aggregation system is a 
device used to determine changes in platelet shape and platelet 
aggregation following the addition of an aggregating reagent to a 
platelet-rich plasma.
    (b) Classification. Class II (performance standards).

[45 FR 60602, Sept. 12, 1980]



Sec. 864.5800  Automated sedimentation rate device.

    (a) Identification. An automated sedimentation rate device is an 
instrument that measures automatically the erythrocyte sedimentation 
rate in

[[Page 219]]

whole blood. Because an increased sedimentation rate indicates tissue 
damage or inflammation, the erythrocyte sedimentation rate device is 
useful in monitoring treatment of a disease.
    (b) Classification. Class I. The device is exempt from the premarket 
notification procedures in subpart E of part 807 of this chapter.

[45 FR 60602, Sept. 12, 1980, as amended at 54 FR 25045, June 12, 1989]



Sec. 864.5850  Automated slide spinner.

    (a) Identification. An automated slide spinner is a device that 
prepares automatically a blood film on a microscope slide using a small 
amount of peripheral blood (blood circulating in one of the body's 
extremities, such as the arm).
    (b) Classification. Class I. The device is exempt from the premarket 
notification procedures in subpart E of part 807 of this chapter.

[45 FR 60603, Sept. 12, 1980, as amended at 54 FR 25045, June 12, 1989]



Sec. 864.5950  Blood volume measuring device.

    (a) Identification. A blood volume measuring device is a manual, 
semiautomated, or automated system that is used to calculate the red 
cell mass, plasma volume, and total blood volume.
    (b) Classification. Class II (performance standards).

[45 FR 60603, Sept. 12, 1980]



                  Subpart G--Manual Hematology Devices



Sec. 864.6100  Bleeding time device.

    (a) Identification. A bleeding time device is a device, usually 
employing two spring-loaded blades, that produces two small incisions in 
the patient's skin. The length of time required for the bleeding to stop 
is a measure of the effectiveness of the coagulation system, primarily 
the platelets.
    (b) Classification. Class II (special controls). The device is 
exempt from the premarket notification procedures in subpart E of part 
807 of this chapter subject to Sec. 864.9.

[45 FR 60604, Sept. 12, 1980, as amended at 63 FR 59225, Nov. 3, 1998]



Sec. 864.6150  Capillary blood collection tube.

    (a) Identification. A capillary blood collection tube is a plain or 
heparinized glass tube of very small diameter used to collect blood by 
capillary action.
    (b) Classification. Class I (general controls). The device is exempt 
from the premarket notification procedures in subpart E of part 807 of 
this chapter subject to Sec. 864.9.

[45 FR 60604, Sept. 12, 1980, as amended at 54 FR 25045, June 12, 1989; 
65 FR 2310, Jan. 14, 2000]



Sec. 864.6160  Manual blood cell counting device.

    (a) Identification. A manual blood cell counting device is a device 
used to count red blood cells, white blood cells, or blood platelets.
    (b) Classification. Class I. The device is exempt from the premarket 
notification procedures in subpart E of part 807 of this chapter.

[45 FR 60605, Sept. 12, 1980, as amended at 54 FR 25045, June 12, 1989]



Sec. 864.6400  Hematocrit measuring device.

    (a) Identification. A hematocrit measuring device is a system 
consisting of instruments, tubes, racks, and a sealer and a holder. The 
device is used to measure the packed red cell volume in blood to 
determine whether the patient's total red cell volume is normal or 
abnormal. Abnormal states include anemia (an abnormally low total red 
cell volume) and erythrocytosis (an abnormally high total red cell 
mass). The packed red cell volume is produced by centrifuging a given 
volume of blood.
    (b) Classification. Class II (special controls). The device is 
exempt from the premarket notification procedures in subpart E of part 
807 of this chapter subject to Sec. 864.9.

[45 FR 60606, Sept. 12, 1980, as amended at 63 FR 59225, Nov. 3, 1998]

[[Page 220]]



Sec. 864.6550  Occult blood test.

    (a) Identification. An occult blood test is a device used to detect 
occult blood in urine or feces. (Occult blood is blood present in such 
small quantities that it can be detected only by chemical tests of 
suspected material, or by microscopic or spectroscopic examination.)
    (b) Classification. Class II (performance standards).

[45 FR 60606, Sept. 12, 1980]



Sec. 864.6600  Osmotic fragility test.

    (a) Identification. An osmotic fragility test is a device used to 
determine the resistance of red blood cells to hemolysis (destruction) 
in varying concentrations of hypotonic saline solutions.
    (b) Classification. Class I. The device is exempt from the premarket 
notification procedures in subpart E of part 807 of this chapter.

[45 FR 60607, Sept. 12, 1980, as amended at 54 FR 25045, June 12, 1989]



Sec. 864.6650  Platelet adhesion test.

    (a) Identification. A platelet adhesion test is a device used to 
determine in vitro platelet function.
    (b) Classification. Class II (performance standards).

[45 FR 60608, Sept. 12, 1980]



Sec. 864.6675  Platelet aggregometer.

    (a) Identification. A platelet aggregometer is a device, used to 
determine changes in platelet shape and platelet aggregation following 
the addition of an aggregating reagent to a platelet rich plasma.
    (b) Classification. Class II (performance standards).

[45 FR 60608, Sept. 12, 1980]



Sec. 864.6700  Erythrocyte sedimentation rate test.

    (a) Identification. An erythrocyte sedimentation rate test is a 
device that measures the length of time required for the red cells in a 
blood sample to fall a specified distance or a device that measures the 
degree of sedimentation taking place in a given length of time. An 
increased rate indicates tissue damage or inflammation.
    (b) Classification. Class I. The device is exempt from the premarket 
notification procedures in subpart E of part 807 of this chapter.

[45 FR 60608, Sept. 12, 1980, as amended at 54 FR 25045, June 12, 1989]



                 Subpart H--Hematology Kits and Packages



Sec. 864.7040  Adenosine triphosphate release assay.

    (a) Identification. An adenosine triphosphate release assay is a 
device that measures the release of adenosine triphosphate (ATP) from 
platelets following aggregation. This measurement is made on platelet-
rich plasma using a photometer and a luminescent firefly extract. 
Simultaneous measurements of platelet aggregation and ATP release are 
used to evaluate platelet function disorders.
    (b) Classification. Class I (general controls).

[45 FR 60609, Sept. 12, 1980]



Sec. 864.7060  Antithrombin III assay.

    (a) Identification. An antithrombin III assay is a device that is 
used to determine the plasma level of antithrombin III (a substance 
which acts with the anticoagulant heparin to prevent coagulation). This 
determination is used to monitor the administration of heparin in the 
treatment of thrombosis. The determination may also be used in the 
diagnosis of thrombophilia (a congenital deficiency of antithrombin 
III).
    (b) Classification. Class II (performance standards).

[45 FR 60609, Sept. 12, 1980]



Sec. 864.7100  Red blood cell enzyme assay.

    (a) Identification. Red blood cell enzyme assay is a device used to 
measure the activity in red blood cells of clinically important 
enzymatic reactions and their products, such as pyruvate kinase or 2,3-
diphosphoglycerate. A red blood cell enzyme assay is used to determine 
the enzyme defects responsible for a patient's hereditary hemolytic 
anemia.

[[Page 221]]

    (b) Classification. Class II (performance standards).

[45 FR 60610, Sept. 12, 1980]



Sec. 864.7140  Activated whole blood clotting time tests.

    (a) Identification. An activated whole blood clotting time tests is 
a device, used to monitor heparin therapy for the treatment of venous 
thrombosis or pulmonary embolism by measuring the coagulation time of 
whole blood.
    (b) Classification. Class II (performance standards).

[45 FR 60611, Sept. 12, 1980]



Sec. 864.7250  Erythropoietin assay.

    (a) Identification. A erythropoietin assay is a device that measures 
the concentration of erythropoietin (an enzyme that regulates the 
production of red blood cells) in serum or urine. This assay provides 
diagnostic information for the evaluation of erythrocytosis (increased 
total red cell mass) and anemia.
    (b) Classification. Class II. The special control for this device is 
FDA's ``Document for Special Controls for Erythropoietin Assay Premarket 
Notification (510(k)s).''

[45 FR 60612, Sept. 12, 1980, as amended at 52 FR 17733, May 11, 1987; 
65 FR 17144, Mar. 31, 2000]

    Effective Date Note: At 65 FR 17144, Mar. 31, 2000, Sec. 864.7250 
was amended by revising paragraph (b) and by removing paragraph (c), 
effective May 1, 2000. For the convenience of the user, the superseded 
text follows.

Sec. 864.7250  Erythropoietin assay.

                                * * * * *

    (b) Classification. Class III (premarket approval).
    (c) Date PMA or notice of completion of a PDP is required. No 
effective date has been established of the requirement for premarket 
approval. See Sec. 864.3.



Sec. 864.7275  Euglobulin lysis time tests.

    (a) Identification. A euglobulin lysis time test is a device that 
measures the length of time required for the lysis (dissolution) of a 
clot formed from fibrinogen in the euglobulin fraction (that fraction of 
the plasma responsible for the formation of plasmin, a clot lysing 
enzyme). This test evaluates natural fibrinolysis (destruction of a 
blood clot after bleeding has been arrested). The test also will detect 
accelerated fibrinolysis.
    (b) Classification. Class II (performance standards).

[45 FR 60612, Sept. 12, 1980]



Sec. 864.7290  Factor deficiency test.

    (a) Identification. A factor deficiency test is a device used to 
diagnose specific coagulation defects, to monitor certain types of 
therapy, to detect coagulation inhibitors, and to detect a carrier state 
(a person carrying both a recessive gene for a coagulation factor 
deficiency such as hemophilia and the corresponding normal gene).
    (b) Classification. Class II (performance standards).

[45 FR 60613, Sept. 12, 1980]



Sec. 864.7300  Fibrin monomer paracoagulation test.

    (a) Identification. A fibrin monomer paracoagulation test is a 
device used to detect fibrin monomer in the diagnosis of disseminated 
intravascular coagulation (nonlocalized clotting within a blood vessel) 
or in the differential diagnosis between disseminated intravascular 
coagulation and primary fibrinolysis (dissolution of the fibrin in a 
blood clot).
    (b) Classification. Class II. The special control for this device is 
FDA's ``In Vitro Diagnostic Fibrin Monomer Paracoagulation Test.''

[45 FR 60614, Sept. 12, 1980, as amended at 52 FR 17733, May 11, 1987; 
65 FR 17144, Mar. 31, 2000]

    Effective Date Note: At 65 FR 17144, Mar. 31, 2000, Sec. 864.7300 
was amended by revising paragraph (b) and by removing paragraph (c), 
effective May 1, 2000. For the convenience of the user, the superseded 
text follows.

Sec. 864.7300  Fibrin monomer paracoagulation test.

                                * * * * *

    (b) Classification. Class III (premarket approval).
    (c) Date PMA or notice of completion of a PDP is required. No 
effective date has been established of the requirement for premarket 
approval. See Sec. 864.3.

[[Page 222]]



Sec. 864.7320  Fibrinogen/fibrin degradation products assay.

    (a) Identification. A fibrinogen/fibrin degradation products assay 
is a device used to detect and measure fibrinogen degradation products 
and fibrin degradation products (protein fragments produced by the 
enzymatic action of plasmin on fibrinogen and fibrin) as an aid in 
detecting the presence and degree of intravascular coagulation and 
fibrinolysis (the dissolution of the fibrin in a blood clot) and in 
monitoring therapy for disseminated intravascular coagulation 
(nonlocalized clotting in the blood vessels).
    (b) Classification. Class II (performance standards).

[45 FR 60615, Sept. 12, 1980]



Sec. 864.7340  Fibrinogen determination system.

    (a) Identification. A fibrinogen determination system is a device 
that consists of the instruments, reagents, standards, and controls used 
to determine the fibrinogen levels in disseminated intravascular 
coagulation (nonlocalized clotting within the blood vessels) and primary 
fibrinolysis (the dissolution of fibrin in a blood clot).
    (b) Classification. Class II (performance standards).

[45 FR 60615, Sept. 12, 1980]



Sec. 864.7360  Erythrocytic glucose-6-phosphate dehydrogenase assay.

    (a) Identification. An erythrocytic glucose-6-phosphate 
dehydrogenase assay is a device used to measure the activity of the 
enzyme glucose-6-phosphate dehydrogenase or of glucose-6-phosphate 
dehydrogenase isoenzymes. The results of this assay are used in the 
diagnosis and treatment of nonspherocytic congenital hemolytic anemia or 
drug-induced hemolytic anemia associated with a glucose-6-phosphate 
dehydrogenase deficiency. This generic device includes assays based on 
fluorescence, electrophoresis, methemoglobin reduction, catalase 
inhibition, and ultraviolet kinetics.
    (b) Classification. Class II (performance standards).

[45 FR 60616, Sept. 12, 1980]



Sec. 864.7375  Glutathione reductase assay.

    (a) Identification. A glutathione reductase assay is a device used 
to determine the activity of the enzyme glutathione reductase in serum, 
plasma, or erythrocytes by such techniques as fluorescence and 
photometry. The results of this assay are used in the diagnosis of liver 
disease, glutathione reductase deficiency, or riboflavin deficiency.
    (b) Classification. Class II (performance standards).

[45 FR 60616, Sept. 12, 1980]



Sec. 864.7400  Hemoglobin A2 assay.

    (a) Identification. A hemoglobin A2 assay is a device 
used to determine the hemoglobin A2 content of human blood. 
The measurement of hemoglobin A2 is used in the diagnosis of 
the thalassemias (hereditary hemolytic anemias characterized by 
decreased synthesis of one or more types of hemoglobin polypeptide 
chains).
    (b) Classification. Class II (performance standards).

[45 FR 60617, Sept. 12, 1980]



Sec. 864.7415  Abnormal hemoglobin assay.

    (a) Identification. An abnormal hemoglobin assay is a device 
consisting of the reagents, apparatus, instrumentation, and controls 
necessary to isolate and identify abnormal genetically determined 
hemoglobin types.
    (b) Classification. Class II (performance standards).

[45 FR 60618, Sept. 12, 1980]



Sec. 864.7425  Carboxyhemoglobin assay.

    (a) Identification. A carboxyhemoglobin assay is a device used to 
determine the carboxyhemoglobin (the compound formed when hemoglobin is 
exposed to carbon monoxide) content of human blood as an aid in the 
diagnosis of carbon monoxide poisoning. This measurement may be made 
using methods such as spectroscopy, colorimetry, spectrophotometry, and 
gasometry.
    (b) Classification. Class II (performance standards).

[45 FR 60619, Sept. 12, 1980]

[[Page 223]]



Sec. 864.7440  Electrophoretic hemoglobin analysis system.

    (a) Identification. An electrophoretic hemoglobin analysis system is 
a device that electrophoretically separates and identifies normal and 
abnormal hemoglobin types as an aid in the diagnosis of anemia or 
erythrocytosis (increased total red cell mass) due to a hemoglobin 
abnormality.
    (b) Classification. Class II (performance standards).

[45 FR 60620, Sept. 12, 1980]



Sec. 864.7455  Fetal hemoglobin assay.

    (a) Identification. A fetal hemoglobin assay is a device that is 
used to determine the presence and distribution of fetal hemoglobin 
(hemoglobin F) in red cells or to measure the amount of fetal hemoglobin 
present. The assay may be used to detect fetal red cells in the maternal 
circulation or to detect the elevated levels of fetal hemoglobin 
exhibited in cases of hemoglobin abnormalities such as thalassemia (a 
hereditary hemolytic anemia characterized by a decreased synthesis of 
one or more types of hemoglobin polypeptide chains). The hemoglobin 
determination may be made by methods such as electrophoresis, alkali 
denaturation, column chromatography, or radial immunodiffusion.
    (b) Classification. Class II (performance standards).

[45 FR 60620, Sept. 12, 1980]



Sec. 864.7470  Glycosylated hemoglobin assay.

    (a) Identification. A glycosylated hemoglobin assay is a device used 
to measure the glycosylated hemoglobins (A1a, A1b, 
and A1c) in a patient's blood by a column chromatographic 
procedure. Measurement of glycosylated hemoglobin is used to assess the 
level of control of a patient's diabetes and to determine the proper 
insulin dosage for a patient. Elevated levels of glycosylated hemoglobin 
indicate uncontrolled diabetes in a patient.
    (b) Classification. Class II (performance standards).

[45 FR 60621, Sept. 12, 1980]



Sec. 864.7490  Sulfhemoglobin assay.

    (a) Identification. A sulfhemoglobin assay is a device consisting of 
the reagents, calibrators, controls, and instrumentation used to 
determine the sulfhemoglobin (a compound of sulfur and hemoglobin) 
content of human blood as an aid in the diagnosis of sulfhemoglobinemia 
(presence of sulfhemoglobin in the blood due to drug administration or 
exposure to a poison). This measurement may be made using methods such 
as spectroscopy, colorimetry, spectrophotometry, or gasometry.
    (b) Classification. Class II (performance standards).

[45 FR 60621, Sept. 12, 1980]



Sec. 864.7500  Whole blood hemoglobin assays.

    (a) Identification. A whole blood hemoglobin assay is a device 
consisting or reagents, calibrators, controls, or photometric or 
spectrophotometric instrumentation used to measure the hemoglobin 
content of whole blood for the detection of anemia. This generic device 
category does not include automated hemoglobin systems.
    (b) Classification. Class II (performance standards).

[45 FR 60622, Sept. 12, 1980]



Sec. 864.7525  Heparin assay.

    (a) Identification. A heparin assay is a device used to determine 
the level of the anticoagulant heparin in the patient's circulation. 
These assays are quantitative clotting time procedures using the effect 
of heparin on activated coagulation factor X (Stuart factor) or 
procedures based on the neutralization of heparin by protamine sulfate 
(a protein that neutralizes heparin).
    (b) Classification. Class II (performance standards).

[45 FR 60623, Sept. 12, 1980]



Sec. 864.7660  Leukocyte alkaline phosphatase test.

    (a) Identification. A leukocyte alkaline phosphatase test is a 
device used to identify the enzyme leukocyte alkaline phosphatase in 
neutrophilic granulocytes (granular leukocytes stainable by neutral 
dyes). The

[[Page 224]]

cytochemical identification of alkaline phosphatase depends on the 
formation of blue granules in cells containing alkaline phosphatase. The 
results of this test are used to differentiate chronic granulocytic 
leukemia (a malignant disease characterized by excessive overgrowth of 
granulocytes in the bone marrow) and reactions that resemble true 
leukemia, such as those occuring in severe infections and polycythemia 
(increased total red cell mass).
    (b) Classification. Class I. The device is exempt from the premarket 
notification procedures in subpart E of part 807 of this chapter.

[45 FR 60623, Sept. 12, 1980, as amended at 59 FR 63007, Dec. 7, 1994]



Sec. 864.7675  Leukocyte peroxidase test.

    (a) Identification. A leukocyte peroxidase test is a device used to 
distinguish certain myeloid cells derived from the bone marrow, i.e., 
neutrophils, eosinophils, and monocytes, from lymphoid cells of the 
lymphatic system and erythroid cells of the red blood cell series on the 
basis of their peroxidase activity as evidenced by staining. The results 
of this test are used in the differential diagnosis of the leukemias.
    (b) Classification. Class I. The device is exempt from the premarket 
notification procedures in subpart E of part 807 of this chapter.

[45 FR 60624, Sept. 12, 1980, as amended at 59 FR 63007, Dec. 7, 1994]



Sec. 864.7695  Platelet factor 4 radioimmunoassay.

    (a) Identification. A platelet factor 4 radioimmunoassay is a device 
used to measure the level of platelet factor 4, a protein released 
during platelet activation by radioimmunoassay. This device measures 
platelet activiation, which may indicate a coagulation disorder, such as 
myocardial infarction or coronary artery disease.
    (b) Classification. Class II (performance standards).

[45 FR 60625, Sept. 12, 1980; 46 FR 14890, Mar. 3, 1981]



Sec. 864.7720  Prothrombin consumption test.

    (a) Identification. A prothrombin consumption tests is a device that 
measures the patient's capacity to generate thromboplastin in the 
coagulation process. The test also is an indirect indicator of 
qualitative or quantitative platelet abnormalities. It is a screening 
test for thrombocytopenia (decreased number of blood platelets) and 
hemophilia A and B.
    (b) Classification. Class II (performance standards).

[45 FR 60625, Sept. 12, 1980]



Sec. 864.7735  Prothrombin-proconvertin test and thrombotest.

    (a) Identification. The prothrombin-proconvertin test and 
thrombotest are devices used in the regulation of coumarin therapy 
(administration of a coumarin anticoagulant such as sodium warfarin in 
the treatment of venous thrombosis and pulmonary embolism) and as a 
diagnostic test in conjunction with, or in place of, the Quick 
prothrombin time test to detect coagulation disorders.
    (b) Classification. Class II (performance standards).

[45 FR 60626, Sept. 12, 1980]



Sec. 864.7750  Prothrombin time test.

    (a) Identification. A prothrombin time test is a device used as a 
general screening procedure for the detection of possible clotting 
factor deficiencies in the extrinsic coagulation pathway, which involves 
the reaction between coagulation factors III and VII, and to monitor 
patients receiving coumarin therapy (the administration of one of the 
coumarin anticoagulants in the treatment of venous thrombosis or 
pulmonary embolism).
    (b) Classification. Class II (performance standards).

[45 FR 60626, Sept. 12, 1980]



Sec. 864.7825  Sickle cell test.

    (a) Identification. A sickle cell test is a device used to determine 
the sickle cell hemoglobin content of human blood to detect sickle cell 
trait or sickle cell diseases.
    (b) Classification. Class II (performance standards).

[45 FR 60627, Sept. 12, 1980]

[[Page 225]]



Sec. 864.7875  Thrombin time test.

    (a) Identification. A thrombin time test is a device used to measure 
fibrinogen concentration and detect fibrin or fibrinogen split products 
for the evaluation of bleeding disorders.
    (b) Classification. Class II (performance standards).

[45 FR 60628, Sept. 12, 1980]



Sec. 864.7900  Thromboplastin generation test.

    (a) Identification. A thromboplastin generation test is a device 
used to detect and identify coagulation factor deficiencies and 
coagulation inhibitors.
    (b) Classification. Class I. The device is exempt from the premarket 
notification procedures in subpart E of part 807 of this chapter.

[45 FR 60628, Sept. 12, 1980, as amended at 59 FR 63007, Dec. 7, 1994]



Sec. 864.7925  Partial thromboplastin time tests.

    (a) Identification. A partial thromboplastin time test is a device 
used for primary screening for coagulation abnormalities, for evaluation 
of the effect of therapy on procoagulant disorders, and as an assay for 
coagulation factor deficiencies of the intrinsic coagulation pathway.
    (b) Classification. Class II (performance standards).

[45 FR 60629, Sept. 12, 1980]



                     Subpart I--Hematology Reagents



Sec. 864.8100  Bothrops atrox reagent.

    (a) Identification. A Bothrops atrox reagent is a device made from 
snake venom and used to determine blood fibrinogen levels to aid in the 
evaluation of disseminated intravascular coagulation (nonlocalized 
clotting in the blood vessels) in patients receiving heparin therapy 
(the administration of the anticoagulant heparin in the treatment of 
thrombosis) or as an aid in the classification of dysfibrinogenemia 
(presence in the plasma of functionally defective fibrinogen).
    (b) Classification. Class II (performance standards).

[45 FR 60629, Sept. 12, 1980]



Sec. 864.8150  Calibrator for cell indices.

    (a) Identification. A calibrator for cell indices is a device that 
approximates whole blood or certain blood cells and that is used to set 
an instrument intended to measure mean cell volume (MCV), mean 
corpuscular hemoglobin (MCH), and mean corpuscular hemoglobin 
concentration (MCHC), or other cell indices. It is a suspension of 
particles or cells whose size, shape, concentration, and other 
characteristics have been precisely and accurately determined.
    (b) Classification. Class II (performance standards).

[45 FR 60631, Sept. 12, 1980]



Sec. 864.8165  Calibrator for hemoglobin or hematocrit measurement.

    (a) Identification. A calibrator for hemoglobin or hematocrit 
measurement is a device that approximates whole blood, red blood cells, 
or a hemoglobin derivative and that is used to set instruments intended 
to measure hemoglobin, the hematocrit, or both. It is a material whose 
characteristics have been precisely and accurately determined.
    (b) Classification. Class II (performance standards).

[45 FR 60632, Sept. 12, 1980]



Sec. 864.8175  Calibrator for platelet counting.

    (a) Identification. A calibrator for platelet counting is a device 
that resembles platelets in plasma or whole blood and that is used to 
set a platelet counting instrument. It is a suspension of particles or 
cells whose size, shape concentration, and other characteristics have 
been precisely and accurately determined.
    (b) Classification. Class II (performance standards).

[45 FR 60633, Sept. 12, 1980]



Sec. 864.8185  Calibrator for red cell and white cell counting.

    (a) Identification. A calibrator for red cell and white cell 
counting is a device that resembles red or white blood cells and that is 
used to set instruments intended to count red cells, white cells, or 
both. It is a suspension of particles

[[Page 226]]

or cells whose size, shape, concentration, and other characteristics 
have been precisely and accurately determined.
    (b) Classification. Class II (performance standards).

[45 FR 60634, Sept. 12, 1980]



Sec. 864.8200  Blood cell diluent.

    (a) Identification. A blood cell diluent is a device used to dilute 
blood for further testing, such as blood cell counting.
    (b) Classification. Class I. The device is exempt from the premarket 
notification procedures in subpart E of part 807 of this chapter.

[45 FR 60635, Sept. 12, 1980, as amended at 54 FR 25045, June 12, 1989]



Sec. 864.8500  Lymphocyte separation medium.

    (a) Identification. A lymphocyte separation medium is a device used 
to isolate lymphocytes from whole blood.
    (b) Classification. Class I. The device is exempt from the premarket 
notification procedures in subpart E of part 807 of this chapter.

[45 FR 60636, Sept. 12, 1980, as amended at 59 FR 63007, Dec. 7, 1994]



Sec. 864.8540  Red cell lysing reagent.

    (a) Identification. A red cell lysing reagent is a device used to 
lyse (destroy) red blood cells for hemoglobin determinations or aid in 
the counting of white blood cells.
    (b) Classification. Class I. The device is exempt from the premarket 
notification procedures in subpart E of part 807 of this chapter.

[45 FR 60636, Sept. 12, 1980, as amended at 54 FR 25045, June 12, 1989]



Sec. 864.8625  Hematology quality control mixture.

    (a) Identification. A hematology quality control mixture is a device 
used to ascertain the accuracy and precision of manual, semiautomated, 
and automated determinations of cell parameters such as white cell count 
(WBC), red cell count (RBC), platelet count (PLT), hemoglobin, 
hematocrit (HCT), mean corpuscular volume (MCV), mean corpuscular 
hemoglobin (MCH), and mean corpuscular hemoglobin concentration (MCHC).
    (b) Classification. Class II (performance standards).

[45 FR 60637, Sept. 12, 1980]



Sec. 864.8950  Russell viper venom reagent.

    (a) Identification. Russell viper venom reagent is a device used to 
determine the cause of an increase in the prothrombin time.
    (b) Classification. Class I (general controls).

[45 FR 60637, Sept. 12, 1980]



 Subpart J--Products Used In Establishments That Manufacture Blood and 
                             Blood Products



Sec. 864.9050  Blood bank supplies.

    (a) Identification. Blood bank supplies are general purpose devices 
intended for in vitro use in blood banking. This generic type of device 
includes products such as blood bank pipettes, blood grouping slides, 
blood typing tubes, blood typing racks, and cold packs for antisera 
reagents. The device does not include articles that are licensed by the 
Center for Biologics Evaluation and Research of the Food and Drug 
Administration.
    (b) Classification. Class I (general controls).

[45 FR 60638, Sept. 12, 1980, as amended at 53 FR 11253, Apr. 6, 1988]



Sec. 864.9100  Empty container for the collection and processing of blood and blood components.

    (a) Identification. An empty container for the collection and 
processing of blood and blood components is a device intended for 
medical purposes that is an empty plastic bag or plastic or glass bottle 
used to collect, store, or transfer blood and blood components for 
further processing.
    (b) Classification. Class II (performance standards).

[45 FR 60638, Sept. 12, 1980]

[[Page 227]]



Sec. 864.9125  Vacuum-assisted blood collection system.

    (a) Identification. A vacuum-assisted blood collection system is a 
device intended for medical purposes that uses a vacuum to draw blood 
for subsequent reinfusion.
    (b) Classification. Class I (general controls). The manual device is 
exempt from the premarket notification procedures in subpart E of part 
807 of this chapter subject to Sec. 864.9.

[45 FR 60639, Sept. 12, 1980, as amended at 65 FR 2310, Jan. 14, 2000]



Sec. 864.9145  Processing system for frozen blood.

    (a) Identification. A processing system for frozen blood is a device 
used to glycerolize red blood cells prior to freezing to minimize 
hemolysis (disruption of the red cell membrane accompanied by the 
release of hemoglobin) due to freezing and thawing of red blood cells 
and to deglycerolize and wash thawed cells for subsequent reinfusion.
    (b) Classification. Class II (performance standards).

[45 FR 60639, Sept. 12, 1980]



Sec. 864.9160  Blood group substances of nonhuman origin for in vitro diagnostic use.

    (a) Identification. Blood group substances of nonhuman origin for in 
vitro diagnostic use are materials, such as blood group specific 
substances prepared from nonhuman sources (e.g., pigs, cows, and horses) 
used to detect, identify, or neutralize antibodies to various human 
blood group antigens. This generic type of device does not include 
materials that are licensed by the Center for Biologics Evaluation and 
Research of the Food and Drug Administration.
    (b) Classification. Class II (special controls). The device is 
exempt from the premarket notification procedures in subpart E of part 
807 of this chapter subject to Sec. 864.9.

[45 FR 60640, Sept. 12, 1980, as amended at 53 FR 11253, Apr. 6, 1988; 
63 FR 59225, Nov. 3, 1998]



Sec. 864.9175  Automated blood grouping and antibody test system.

    (a) Identification. An automated blood grouping and antibody test 
system is a device used to group erythrocytes (red blood cells) and to 
detect antibodies to blood group antigens.
    (b) Classification. Class II (performance standards).

[45 FR 60641, Sept. 12, 1980]



Sec. 864.9185  Blood grouping view box.

    (a) Identification. A blood grouping view box is a device with a 
glass or plastic viewing surface, which may be illuminated and heated, 
that is used to view cell reactions in antigen-antibody testing.
    (b) Classification. Class I (general controls). The device is exempt 
from the premarket notification procedures in subpart E of part 807 of 
this chapter subject to Sec. 864.9.

[45 FR 60641, Sept. 12, 1980, as amended at 65 FR 2310, Jan. 14, 2000]



Sec. 864.9195  Blood mixing devices and blood weighing devices.

    (a) Identification. A blood mixing device is a device intended for 
medical purposes that is used to mix blood or blood components by 
agitation. A blood weighing device is a device intended for medical 
purposes that is used to weigh blood or blood components as they are 
collected.
    (b) Classification. Class I (general controls). The manual device is 
exempt from the premarket notification procedures in subpart E of part 
807 of this chapter subject to Sec. 864.9.

[45 FR 60642, Sept. 12, 1980, as amended at 65 FR 2310, Jan. 14, 2000]



Sec. 864.9205  Blood and plasma warming device.

    (a) Nonelectromagnetic blood or plasma warming device--(1) 
Identification. A nonelectromagnetic blood and plasma warming device is 
a device that warms blood or plasma, by means other than electromagnetic 
radiation, prior to administration.
    (2) Classification. Class II (performance standards).
    (b) Electromagnetic blood and plasma warming device--(1) 
Identification. An electromagnetic blood and plasma

[[Page 228]]

warming device is a device that employs electromagnetic radiation 
(radiowaves or microwaves) to warm a bag or bottle of blood or plasma 
prior to administration.
    (2) Classfication. Class III (premarket approval).
    (c) Date PMA or notice of completion of a PDP is required. No 
effective date has been established of the requirement for premarket 
approval for the device described in paragraph (b)(1). See Sec. 864.3.

[45 FR 60642, Sept. 12, 1980, as amended at 52 FR 17733, May 11, 1987]



Sec. 864.9225  Cell-freezing apparatus and reagents for in vitro diagnostic use.

    (a) Identification. Cell-freezing apparatus and reagents for in 
vitro diagnostic use are devices used to freeze human red blood cells 
for in vitro diagnostic use.
    (b) Classification. Class I (general controls). The device is exempt 
from the premarket notification procedures in subpart E of part 807 of 
this chapter subject to Sec. 864.9.

[45 FR 60643, Sept. 12, 1980, as amended at 65 FR 2310, Jan. 14, 2000]



Sec. 864.9245  Automated blood cell separator.

    (a) Identification. An automated blood cell separator is a device 
that automatically removes whole blood from a donor, separates the blood 
into components (red blood cells, white blood cells, plasma, and 
platelets), retains one or more of the components, and returns the 
remainder of the blood to the donor. The components obtained are 
transfused or used to prepare blood products for administration. These 
devices operate on either a centrifugal separation principle or a 
filtration principle. The separation bowls of centrifugal blood cell 
separators may be reusable or disposable.
    (b) Classification. Class III (premarket approval).
    (c) Date PMA or notice of completion of a PDP is required. No 
effective date has been established of the requirement for premarket 
approval. See Sec. 864.3.

[45 FR 60645, Sept. 12, 1980, as amended at 52 FR 17733, May 11, 1987]



Sec. 864.9275  Blood bank centrifuge for in vitro diagnostic use.

    (a) Identification. A blood bank centrifuge for in vitro diagnostic 
use is a device used only to separate blood cells for further diagnostic 
testing.
    (b) Classification. Class I (general controls). The device is exempt 
from the premarket notification procedures in subpart E of part 807 of 
this chapter subject to Sec. 864.9.

[45 FR 60645, Sept. 12, 1980, as amended at 65 FR 2310, Jan. 14, 2000]



Sec. 864.9285  Automated cell-washing centrifuge for immuno-hematology.

    (a) Identification. An automated cell-washing centrifuge for immuno-
hematology is a device used to separate and prepare cells and sera for 
further in vitro diagnostic testing.
    (b) Classification. Class II (performance standards).

[45 FR 60646, Sept. 12, 1980]



Sec. 864.9300  Automated Coombs test systems.

    (a) Identification. An automated Coombs test system is a device used 
to detect and identify antibodies in patient sera or antibodies bound to 
red cells. The Coombs test is used for the diagnosis of hemolytic 
disease of the newborn, and autoimmune hemolytic anemia. The test is 
also used in crossmatching and in investigating transfusion reactions 
and drug-induced red cell sensitization.
    (b) Classification. Class II (performance standards).

[45 FR 60646, Sept. 12, 1980]



Sec. 864.9320  Copper sulfate solution for specific gravity determinations.

    (a) Identification. A copper sulfate solution for specific gravity 
determinations is a device used to determine whether the hemoglobin 
content of a potential donor's blood meets the required level (12.5 
grams per 100 milliliters of blood for women and 13.5 grams per 100 
milliliters of blood for men).
    (b) Classification. Class I (general controls). The device is exempt 
from the premarket notification procedures in

[[Page 229]]

subpart E of part 807 of this chapter subject to Sec. 864.9.

[45 FR 60647, Sept. 12, 1980, as amended at 65 FR 2310, Jan. 14, 2000]



Sec. 864.9400  Stabilized enzyme solution.

    (a) Identification. A stabilized enzyme solution is a reagent 
intended for medical purposes that is used to enhance the reactivity of 
red blood cells with certain antibodies, including antibodies that are 
not detectable by other techniques. These enzyme solutions include 
papain, bromelin, ficin, and trypsin.
    (b) Classification. Class II (performance standards).

[45 FR 60647, Sept. 12, 1980]



Sec. 864.9550  Lectins and protectins.

    (a) Identification. Lectins and protectins are proteins derived from 
plants and lower animals that cause cell agglutination in the presence 
of certain antigens. These substances are used to detect blood group 
antigens for in vitro diagnostic purposes.
    (b) Classification. Class II (special controls). The device is 
exempt from the premarket notification procedures in subpart E of part 
807 of this chapter subject to Sec. 864.9.

[45 FR 60648, Sept. 12, 1980, as amended at 63 FR 59226, Nov. 3, 1998]



Sec. 864.9575  Environmental chamber for storage of platelet concentrate.

    (a) Identification. An environmental chamber for storage of platelet 
concentrate is a device used to hold platelet-rich plasma within a 
preselected temperature range.
    (b) Classification. Class II (special controls). The device is 
exempt from the premarket notification procedures in subpart E of part 
807 of this chapter subject to Sec. 864.9.

[45 FR 60648, Sept. 12, 1980, as amended at 63 FR 59226, Nov. 3, 1998]



Sec. 864.9600  Potentiating media for in vitro diagnostic use.

    (a) Identification. Potentiating media for in vitro diagnostic use 
are media, such as bovine albumin, that are used to suspend red cells 
and to enhance cell reactions for antigen-antibody testing.
    (b) Classification. Class II (special controls). The device is 
exempt from the premarket notification procedures in subpart E of part 
807 of this chapter subject to Sec. 864.9.

[45 FR 60649, Sept. 12, 1980, as amended at 63 FR 59226, Nov. 3, 1998]



Sec. 864.9650  Quality control kit for blood banking reagents.

    (a) Identification. A quality control kit for blood banking reagents 
is a device that consists of sera, cells, buffers, and antibodies used 
to determine the specificity, potency, and reactivity of the cells and 
reagents used for blood banking.
    (b) Classification. Class II (performance standards).

[45 FR 60649, Sept. 12, 1980]



Sec. 864.9700  Blood storage refrigerator and blood storage freezer.

    (a) Identification. A blood storage refrigerator and a blood storage 
freezer are devices intended for medical purposes that are used to 
preserve blood and blood products by storing them at cold or freezing 
temperatures.
    (b) Classification. Class II (special controls). The device is 
exempt from the premarket notification procedures in subpart E of part 
807 of this chapter subject to Sec. 864.9.

[45 FR 60650, Sept. 12, 1980, as amended at 63 FR 59226, Nov. 3, 1998]



Sec. 864.9750  Heat-sealing device.

    (a) Identification. A heat-sealing device is a device intended for 
medical purposes that uses heat to seal plastic bags containing blood or 
blood components.
    (b) Classification. Class I (general controls). The device is exempt 
from the premarket notification procedures in subpart E of part 807 of 
this chapter subject to Sec. 864.9.

[45 FR 60650, Sept. 12, 1980, as amended at 65 FR 2311, Jan. 14, 2000]



Sec. 864.9875  Transfer set.

    (a) Identification. A transfer set is a device intended for medical 
purposes that consists of a piece of tubing with suitable adaptors used 
to transfer blood or plasma from one container to another.

[[Page 230]]

    (b) Classification. Class II (performance standards).

[45 FR 60651, Sept. 12, 1980]



PART 866--IMMUNOLOGY AND MICROBIOLOGY DEVICES--Table of Contents




                      Subpart A--General Provisions

Sec.
866.1  Scope.
866.3  Effective dates of requirement for premarket approval.
866.9  Limitations of exemptions from section 510(k) of the Federal 
          Food, Drug, and Cosmetic Act (the act).

                      Subpart B--Diagnostic Devices

866.1620  Antimicrobial susceptibility test disc.
866.1640  Antimicrobial susceptibility test powder.
866.1700  Culture medium for antimicrobial susceptibility tests.

                     Subpart C--Microbiology Devices

866.2050  Staphylococcal typing bacteriophage.
866.2120  Anaerobic chamber.
866.2160  Coagulase plasma.
866.2170  Automated colony counter.
866.2180  Manual colony counter.
866.2300  Multipurpose culture medium.
866.2320  Differential culture medium.
866.2330  Enriched culture medium.
866.2350  Microbiological assay culture medium.
866.2360  Selective culture medium.
866.2390  Transport culture medium.
866.2410  Culture medium for pathogenic Neisseria spp.
866.2420  Oxidase screening test for gonorrhea.
866.2440  Automated medium dispensing and stacking device.
866.2450  Supplement for culture media.
866.2480  Quality control kit for culture media.
866.2500  Microtiter diluting and dispensing device.
866.2540  Microbiological incubator.
866.2560  Microbial growth monitor.
866.2580  Gas-generating device.
866.2600  Wood's fluorescent lamp.
866.2660  Microorganism differentiation and identification device.
866.2850  Automated zone reader.
866.2900  Microbiological specimen collection and transport device.

                     Subpart D--Serological Reagents

866.3010  Acinetobacter calcoaceticus serological reagents.
866.3020  Adenovirus serological reagents.
866.3035  Arizona spp. serological reagents.
866.3040  Aspergillus spp. serological reagents.
866.3060  Blastomyces dermatitidis serological reagents.
866.3065  Bordetella spp. serological reagents.
866.3085  Brucella spp. serological reagents.
866.3110  Campylobacter fetus serological reagents.
866.3120  Chlamydia serological reagents.
866.3125  Citrobacter spp. serological reagents.
866.3135  Coccidioides immitis serological reagents.
866.3140  Corynebacterium spp. serological reagents.
866.3145  Coxsackievirus serological reagents.
866.3165  Cryptococcus neoformans serological reagents.
866.3175  Cytomegalovirus serological reagents.
866.3200  Echinococcus spp. serological reagents.
866.3205  Echovirus serological reagents.
866.3220  Entamoeba histolytica serological reagents.
866.3235  Epstein-Barr virus serological reagents.
866.3240  Equine encephalomyelitis virus serological reagents.
866.3250  Erysipelothrix rhusiopathiae serological reagents.
866.3255  Escherichia coli serological reagents.
866.3270  Flavobacterium spp. serological reagents.
866.3280  Francisella tularensis serological reagents.
866.3290  Gonococcal antibody test (GAT).
866.3300  Haemophilus spp. serological reagents.
866.3305  Herpes simplex virus serological reagents.
866.3320  Histoplasma capsulatum serological reagents.
866.3330  Influenza virus serological reagents.
866.3340  Klebsiella spp. serological reagents.
866.3350  Leptospira spp. serological reagents.
866.3355  Listeria spp. serological reagents.
866.3360  Lymphocytic choriomeningitis virus serological reagents.
866.3370  Mycobacterium tuberculosis immunofluorescent reagents.
866.3375  Mycoplasma spp. serological reagents.
866.3380  Mumps virus serological reagents.
866.3390  Neisseria spp. direct serological test reagents.
866.3400  Parainfluenza virus serological reagents.
866.3405  Poliovirus serological reagents.
866.3410  Proteus spp. (Weil-Felix) serological reagents.
866.3415  Pseudomonas spp. serological reagents.
866.3460  Rabiesvirus immunofluorescent reagents.

[[Page 231]]

866.3470  Reovirus serological reagents.
866.3480  Respiratory syncytial virus serological reagents.
866.3490  Rhinovirus serological reagents.
866.3500  Rickettsia serological reagents.
866.3510  Rubella virus serological reagents.
866.3520  Rubeola (measles) virus serological reagents.
866.3550  Salmonella spp. serological reagents.
866.3600  Schistosoma spp. serological reagents.
866.3630  Serratia spp. serological reagents.
866.3660  Shigella spp. serological reagents.
866.3680  Sporothrix schenckii serological reagents.
866.3700  Staphylococcus aureus serological reagents.
866.3720  Streptococcus spp. exoenzyme reagents.
866.3740  Streptococcus spp. serological reagents.
866.3780  Toxoplasma gondii serological reagents.
866.3820  Treponema pallidum nontreponemal test reagents.
866.3830  Treponema pallidum treponemal test reagents.
866.3850  Trichinella spiralis serological reagents.
866.3870  Trypanosoma spp. serological reagents.
866.3900  Varicella-zoster virus serological reagents.
866.3930  Vibrio cholerae serological reagents.

         Subpart E--Immunology Laboratory Equipment and Reagents

866.4100  Complement reagent.
866.4500  Immunoelectrophoresis equipment.
866.4520  Immunofluorometer equipment.
866.4540  Immunonephelometer equipment.
866.4600  Ouchterlony agar plate.
866.4800  Radial immunodiffusion plate.
866.4830  Rocket immunoelectrophoresis equipment.
866.4900  Support gel.

                  Subpart F--Immunological Test Systems

866.5040  Albumin immunological test system.
866.5060  Prealbumin immunological test system.
866.5065  Human allotypic marker immunological test system.
866.5080  Alpha-1-antichymotrypsin immunological test system.
866.5090  Antimitochondrial antibody immunological test system.
866.5100  Antinuclear antibody immunological test system.
866.5110  Antiparietal antibody immunological test system.
866.5120  Antismooth muscle antibody immunological test system.
866.5130  Alpha-1-antitrypsin immunological test system.
866.5150  Bence-Jones proteins immunological test system.
866.5160  Beta-globulin immunological test system.
866.5170  Breast milk immunological test system.
866.5200  Carbonic anhydrase B and C immunological test system.
866.5210  Ceruloplasmin immunological test system.
866.5220  Cohn fraction II immunological test system.
866.5230  Colostrum immunological test system.
866.5240  Complement components immunological test system.
866.5250  Complement C1 inhibitor (inactivator) immunological 
          test system.
866.5260  Complement C3b inactivator immunological test 
          system.
866.5270  C-reactive protein immunological test system.
866.5320  Properidin factor B immunological test system.
866.5330  Factor XIII, A, S, immunological test system.
866.5340  Ferritin immunological test system.
866.5350  Fibrinopeptide A immunological test system.
866.5360  Cohn fraction IV immunological test system.
866.5370  Cohn fraction V immunological test system.
866.5380  Free secretory component immunological test system.
866.5400  Alpha-globulin immunological test system.
866.5420  Alpha-1-glycoproteins immunological test system.
866.5425  Alpha-2-glycoproteins immunological test system.
866.5430  Beta-2-glycoprotein I immunological test system.
866.5440  Beta-2-glycoprotein III immunological test system.
866.5460  Haptoglobin immunological test system.
866.5470  Hemoglobin immunological test system.
866.5490  Hemopexin immunological test system.
866.5500  Hypersensitivity pneumonitis immunological test system.
866.5510  Immunoglobulins A, G, M, D, and E immunological test system.
866.5520  Immunoglobulin G (Fab fragment specific) immunological test 
          system.
866.5530  Immunoglobulin G (Fc fragment specific) immunological test 
          system.
866.5540  Immunoglobulin G (Fd fragment specific) immunological test 
          system.
866.5550  Immunoglobulin (light chain specific) immunological test 
          system.
866.5560  Lactic dehydrogenase immunological test system.

[[Page 232]]

866.5570  Lactoferrin immunological test system.
866.5580  Alpha-1-lipoprotein immunological test system.
866.5590  Lipoprotein X immunological test system.
866.5600  Low-density lipoprotein immunological test system.
866.5620  Alpha-2-macroglobulin immunological test system.
866.5630  Beta-2-microglobulin immunological test system.
866.5640  Infectious mononucleosis immunological test system.
866.5660  Multiple autoantibodies immunological test system.
866.5680  Myoglobin immunological test system.
866.5700  Whole human plasma or serum immunological test system.
866.5715  Plasminogen immunological test system.
866.5735  Prothrombin immunological test system.
866.5750  Radioallergosorbent (RAST) immunological test system.
866.5765  Retinol-binding protein immunological test system.
866.5775  Rheumatoid factor immunological test system.
866.5800  Seminal fluid (sperm) immunological test system.
866.5820  Systemic lupus erythematosus immunological test system.
866.5860  Total spinal fluid immunological test system.
866.5870  Thyroid autoantibody immunological test system.
866.5880  Transferrin immunological test system.
866.5890  Inter-alpha trypsin inhibitor immunological test system.

     Subpart G--Tumor Associated Antigen Immunological Test Systems

866.6010  Tumor associated antigen immunological test system.

    Authority: 21 U.S.C. 351, 360, 360c, 360e, 360j, 371.

    Source: 47 FR 50823, Nov. 9, 1982, unless otherwise noted.



                      Subpart A--General Provisions



Sec. 866.1  Scope.

    (a) This part sets forth the classification of immunology and 
microbiology devices intended for human use that are in commercial 
distribution.
    (b) The indentification of a device in a regulation in this part is 
not a precise description of every device that is, or will be, subject 
to the regulation. A manufacturer who submits a premarket notification 
submission for a device under part 807 may not show merely that the 
device is accurately described by the section title and identification 
provisions of a regulation in this part, but shall state why the device 
is substantially equivalent to other devices, as required by 
Sec. 807.87.
    (c) To avoid duplicative listings, an immunology and microbiology 
device that has two or more types of uses (e.g., used both as a 
diagnostic device and as a microbiology device) is listed only in one 
subpart.
    (d) References in this part to regulatory sections of the Code of 
Federal Regulations are to chapter I of title 21, unless otherwise 
noted.

[52 FR 17733, May 11, 1987]



Sec. 866.3  Effective dates of requirement for premarket approval.

    A device included in this part that is classified into class III 
(Premarket approval) shall not be commercially distributed after the 
date shown in the regulation classifying the device unless the 
manufacturer has an approval under section 515 of the act (unless an 
exemption has been granted under section 520(g)(2) of the act). An 
approval under section 515 of the act consists of FDA's issuance of an 
order approving an application for premarket approval (PMA) for the 
device or declaring completed a product development protocol (PDP) for 
the device.
    (a) Before FDA requires that a device commercially distributed 
before the enactment date of the amendments, or a device that has been 
found substantially equivalent to such a device, has an approval under 
section 515 of the act FDA must promulgate a regulation under section 
515(b) of the act requiring such approval, except as provided in 
paragraphs (b) and (c) of this section. Such a regulation under section 
515(b) of the act shall not be effective during the grace period ending 
on the 90th day after its promulgation or on the last day of the 30th 
full calendar month after the regulation that classifies the device into 
class III is effective, whichever is later. See section 501(f)(2)(B) of 
the act. Accordingly, unless an effective date of the requirement for 
premarket approval is shown

[[Page 233]]

in the regulation for a device classified into class III in this part, 
the device may be commercially distributed without FDA's issuance of an 
order approving a PMA or declaring completed a PDP for the device. If 
FDA promulgates a regulation under section 515(b) of the act requiring 
premarket approval for a device, section 501(f)(1)(A) of the act applies 
to the device.
    (b) Any new, not substantially equivalent, device introduced into 
commercial distribution on or after May 28, 1976, including a device 
formerly marketed that has been substantially altered, is classified by 
statute (section 513(f) of the act) into class III without any grace 
period and FDA must have issued an order approving a PMA or declaring 
completed a PDP for the device before the device is commercially 
distributed unless it is reclassified. If FDA knows that a device being 
commercially distributed may be a ``new'' device as defined in this 
section because of any new intended use or other reasons, FDA may codify 
the statutory classification of the device into class III for such new 
use. Accordingly, the regulation for such a class III device states that 
as of the enactment date of the amendments, May 28, 1976, the device 
must have an approval under section 515 of the act before commercial 
distribution.
    (c) A device identified in a regulation in this part that is 
classified into class III and that is subject to the transitional 
provisions of section 520(l) of the act is automatically classified by 
statute into class III and must have an approval under section 515 of 
the act before being commercially distributed. Accordingly, the 
regulation for such a class III transitional device states that as of 
the enactment date of the amendments, May 28, 1976, the device must have 
an approval under section 515 of the act before commercial distribution.

[52 FR 17733, May 11, 1987; 52 FR 22577, June 12, 1987]



Sec. 866.9  Limitations of exemptions from section 510(k) of the Federal Food, Drug, and Cosmetic Act (the act).

    The exemption from the requirement of premarket notification 
(section 510(k) of the act) for a generic type of class I or II device 
is only to the extent that the device has existing or reasonably 
foreseeable characteristics of commercially distributed devices within 
that generic type or, in the case of in vitro diagnostic devices, only 
to the extent that misdiagnosis as a result of using the device would 
not be associated with high morbidity or mortality. Accordingly, 
manufacturers of any commercially distributed class I or II device for 
which FDA has granted an exemption from the requirement of premarket 
notification must still submit a premarket notification to FDA before 
introducing or delivering for introduction into interstate commerce for 
commercial distribution the device when:
    (a) The device is intended for a use different from the intended use 
of a legally marketed device in that generic type of device; e.g., the 
device is intended for a different medical purpose, or the device is 
intended for lay use where the former intended use was by health care 
professionals only;
    (b) The modified device operates using a different fundamental 
scientific technology than a legally marketed device in that generic 
type of device; e.g., a surgical instrument cuts tissue with a laser 
beam rather than with a sharpened metal blade, or an in vitro diagnostic 
device detects or identifies infectious agents by using deoxyribonucleic 
acid (DNA) probe or nucleic acid hybridization technology rather than 
culture or immunoassay technology; or
    (c) The device is an in vitro device that is intended:
    (1) For use in the diagnosis, monitoring, or screening of neoplastic 
diseases with the exception of immunohistochemical devices;
    (2) For use in screening or diagnosis of familial or acquired 
genetic disorders, including inborn errors of metabolism;
    (3) For measuring an analyte that serves as a surrogate marker for 
screening, diagnosis, or monitoring life-threatening diseases such as 
acquired immune deficiency syndrome (AIDS), chronic or active hepatitis, 
tuberculosis, or myocardial infarction or to monitor therapy;
    (4) For assessing the risk of cardiovascular diseases;

[[Page 234]]

    (5) For use in diabetes management;
    (6) For identifying or inferring the identity of a microorganism 
directly from clinical material;
    (7) For detection of antibodies to microorganisms other than 
immunoglobulin G (IgG) or IgG assays when the results are not 
qualitative, or are used to determine immunity, or the assay is intended 
for use in matrices other than serum or plasma;
    (8) For noninvasive testing as defined in Sec. 812.3(k) of this 
chapter; and
    (9) For near patient testing (point of care).

[65 FR 2311, Jan. 14, 2000]



                      Subpart B--Diagnostic Devices



Sec. 866.1620  Antimicrobial susceptibility test disc.

    (a) Identification. An antimicrobial susceptibility test disc is a 
device that consists of antimicrobic-impregnated paper discs used to 
measure by a disc-agar diffusion technique or a disc-broth elution 
technique the in vitro susceptibility of most clinically important 
bacterial pathogens to antimicrobial agents. In the disc-agar diffusion 
technique, bacterial susceptibility is ascertained by directly measuring 
the magnitude of a zone of bacterial inhibition around the disc on an 
agar surface. The disc-broth elution technique is associated with an 
automated rapid susceptibility test system and employs a fluid medium in 
which susceptibility is ascertained by photometrically measuring changes 
in bacterial growth resulting when antimicrobial material is eluted from 
the disc into the fluid medium. Test results are used to determine the 
antimicrobial agent of choice in the treatment of bacterial diseases.
    (b) Classification. Class II (performance standards).



Sec. 866.1640  Antimicrobial susceptibility test powder.

    (a) Identification. An antimicrobial susceptibility test powder is a 
device that consists of an antimicrobial drug powder packaged in vials 
in specified amounts and intended for use in clinical laboratories for 
determining in vitro susceptibility of bacterial pathogens to these 
therapeutic agents. Test results are used to determine the antimicrobial 
agent of choice in the treatment of bacterial diseases.
    (b) Classification. Class II (performance standards).



Sec. 866.1700  Culture medium for antimicrobial susceptibility tests.

    (a) Identification. A culture medium for antimicrobial 
susceptibility tests is a device intended for medical purposes that 
consists of any medium capable of supporting the growth of many of the 
bacterial pathogens that are subject to antimicrobial susceptibility 
tests. The medium should be free of components known to be antagonistic 
to the common agents for which susceptibility tests are performed in the 
treatment of disease.
    (b) Classification. Class II (performance standards).



                     Subpart C--Microbiology Devices



Sec. 866.2050  Staphylococcal typing bacteriophage.

    (a) Identification. A staphylococcal typing bacteriophage is a 
device consisting of a bacterial virus intended for medical purposes to 
identify pathogenic staphylococcal bacteria through use of the 
bacteria's susceptibility to destruction by the virus. Test results are 
used principally for the collection of epidemiological information.
    (b) Classification. Class I. The device is exempt from the premarket 
notification procedures in subpart E of part 807 of this chapter.

[47 FR 50823, Nov. 9, 1982, as amended at 54 FR 25045, June 12, 1989]



Sec. 866.2120  Anaerobic chamber.

    (a) Identification. An anaerobic chamber is a device intended for 
medical purposes to maintain an anaerobic (oxygen free) environment. It 
is used to isolate and cultivate anaerobic microorganisms.
    (b) Classification. Class I (general controls). The device is exempt 
from the premarket notification procedures in subpart E of part 807. The 
device also is exempt from the good manufacturing practice regulation in 
part 820, with the exception of Sec. 820.180, with respect to general 
requirements concerning records, and Sec. 820.198, with respect to 
complaint files.

[[Page 235]]



Sec. 866.2160  Coagulase plasma.

    (a) Identification. Coagulase plasma is a device that consists of 
freeze-dried animal or human plasma that is intended for medical 
purposes to perform coagulase tests primarily on staphylococcal 
bacteria. When reconstituted, the fluid plasma is clotted by the action 
of the enzyme coagulase which is produced by pathogenic staphylococci. 
Test results are used primarily as an aid in the diagnosis of disease 
caused by pathogenic bacteria belonging to the genus Staphylococcus and 
provide epidemiological information on disease caused by these 
microorganisms.
    (b) Classification. Class I. The device is exempt from the premarket 
notification procedures in subpart E of part 807 of this chapter.

[47 FR 50823, Nov. 9, 1982, as amended at 61 FR 1119, Jan. 16, 1996]



Sec. 866.2170  Automated colony counter.

    (a) Identification. An automated colony counter is a mechanical 
device intended for medical purposes to determine the number of 
bacterial colonies present on a bacteriological culture medium contained 
in a petri plate. The number of colonies counted is used in the 
diagnosis of disease as a measure of the degree of bacterial infection.
    (b) Classification. Class I. The device is exempt from the premarket 
notification procedures in subpart E of part 807 of this chapter.

[47 FR 50823, Nov. 9, 1982, as amended at 54 FR 25045, June 12, 1989]



Sec. 866.2180  Manual colony counter.

    (a) Identification. A manual colony counter is a device intended for 
medical purposes that consists of a printed grid system superimposed on 
an illuminated screen. Petri plates containing bacterial colonies to be 
counted are placed on the screen for better viewing and ease of 
counting. The number of colonies counted is used in the diagnosis of 
disease as a measure of the degree of bacterial infection.
    (b) Classification. Class I (general controls). The device is exempt 
from the premarket notification procedures in subpart E of part 807. The 
device also is exempt from the good manufacturing practice regulation in 
part 820, with the exception of Sec. 820.180, with respect to general 
requirements concerning records, and Sec. 820.198, with respect to 
complaint files.



Sec. 866.2300  Multipurpose culture medium.

    (a) Identification. A multipurpose culture medium is a device that 
consists primarily of liquid or solid biological materials intended for 
medical purposes for the cultivation and identification of several types 
of pathogenic microorganisms without the need of additional nutritional 
supplements. Test results aid in the diagnosis of disease and also 
provide epidemiological information on diseases caused by these 
microorganisms.
    (b) Classification. Class I. The device is exempt from the premarket 
notification procedures in subpart E of part 807 of this chapter.

[47 FR 50823, Nov. 9, 1982, as amended at 54 FR 25046, June 12, 1989]



Sec. 866.2320  Differential culture medium.

    (a) Identification. A differential culture medium is a device that 
consists primarily of liquid biological materials intended for medical 
purposes to cultivate and identify different types of pathogenic 
microorganisms. The identification of these microorganisms is 
accomplished by the addition of a specific biochemical component(s) to 
the medium. Microorganisms are identified by a visible change (e.g., a 
color change) in a specific biochemical component(s) which indicates 
that specific metabolic reactions have occurred. Test results aid in the 
diagnosis of disease and also provide epidemiological information on 
diseases caused by these microorganisms.
    (b) Classification. Class I. The device is exempt from the premarket 
notification procedures in subpart E of part 807 of this chapter.

[47 FR 50823, Nov. 9, 1982, as amended at 54 FR 25046, June 12, 1989]



Sec. 866.2330  Enriched culture medium.

    (a) Identification. An enriched culture medium is a device that 
consists primarily of liquid or solid biological materials intended for 
medical purposes

[[Page 236]]

to cultivate and identify fastidious microorganisms (those having 
complex nutritional requirements). The device consists of a relatively 
simple basal medium enriched by the addition of such nutritional 
components as blood, blood serum, vitamins, and extracts of plant or 
animal tissues. The device is used in the diagnosis of disease caused by 
pathogenic microorganisms and also provides epidemiological information 
on these diseases.
    (b) Classification. Class I. The device is exempt from the premarket 
notification procedures in subpart E of part 807 of this chapter.

[47 FR 50823, Nov. 9, 1982, as amended at 54 FR 25046, June 12, 1989]



Sec. 866.2350  Microbiological assay culture medium.

    (a) Identification. A microbiological assay culture medium is a 
device that consists primarily of liquid or solid biological materials 
intended for medical purposes to cultivate selected test microorganisms 
in order to measure by microbiological procedures the concentration in a 
patient's serum of certain substances, such as amino acids, 
antimicrobial agents, and vitamins. The concentration of these 
substances is measured by their ability to promote or inhibit the growth 
of the test organism in the innoculated medium. Test results aid in the 
diagnosis of disease resulting from either deficient or excessive 
amounts of these substances in a patient's serum. Tests results may also 
be used to monitor the effects of the administration of certain 
antimicrobial drugs.
    (b) Classification. Class I. The device is exempt from the premarket 
notification procedures in subpart E of part 807 this chapter.

[47 FR 50823, Nov. 9, 1982, as amended at 54 FR 25046, June 12, 1989]



Sec. 866.2360  Selective culture medium.

    (a) Identification. A selective culture medium is a device that 
consists primarily of liquid or solid biological materials intended for 
medical purposes to cultivate and identify certain pathogenic 
microorganisms. The device contains one or more components that suppress 
the growth of certain microorganisms while either promoting or not 
affecting the growth of other microorganisms. The device aids in the 
diagnosis of disease caused by pathogenic microorganisms and also 
provides epidemiological information on these diseases.
    (b) Classification. Class I. The device is exempt from the premarket 
notification procedures in subpart E of part 807 of this chapter.

[47 FR 50823, Nov. 9, 1982, as amended at 54 FR 25046, June 12, 1989]



Sec. 866.2390  Transport culture medium.

    (a) Identification. A transport culture medium is a device that 
consists of a semisolid, usually non-nutrient, medium that maintains the 
viability of suspected pathogens contained in patient specimens while in 
transit from the specimen collection area to the laboratory. The device 
aids in the diagnosis of disease caused by pathogenic microorganisms and 
also provides epidemiological information on these diseases.
    (b) Classification. Class I (general controls).



Sec. 866.2410  Culture medium for pathogenic Neisseria spp.

    (a) Identification. A culture medium for pathogenic Neisseria spp. 
is a device that consists primarily of liquid or solid biological 
materials used to cultivate and identify pathogenic Neisseria spp. The 
identification aids in the diagnosis of disease caused by bacteria 
belonging to the genus Neisseria, such as epidemic cerebrospinal 
meningitis, other meningococcal disease, and gonorrhea, and also 
provides epidemiological information on these microorganisms.
    (b) Classification. Class II (performance standards).



Sec. 866.2420  Oxidase screening test for gonorrhea.

    (a) Identification. An oxidase screening test for gonorrhea is an in 
vitro device that consists of the articles intended to identify by 
chemical reaction, cytochrome oxidase, an oxidizing enzyme that is 
associated with certain bacteria including Neisseria gonorrhoeae. A 
sample of a male's urethral discharge is obtained on a

[[Page 237]]

swab which is placed into a wetting agent containing an ingredient that 
will react with cytochrome oxidase. When cytochrome oxidase is present, 
the swab turns a dark purple color within 3 minutes. Because it is 
unlikely that cytochrome oxidase-positive organisms other than Neisseria 
gonorrhoeae are present in the urethral discharge of males, the 
identification of cytochrome oxidase with this device indicates 
presumptive infection of the patient with the causative agent of 
gonorrhea.
    (b) Classification. Class III (premarket approval) (transitional 
device).
    (c) Date PMA or notice of completion of a PDP is required. As of May 
28, 1976, an approval under section 515 of the act is required before 
this device may be commercially distributed. See Sec. 866.3.

[47 FR 50823, Nov. 9, 1982, as amended at 52 FR 17734, May 11, 1987]



Sec. 866.2440  Automated medium dispensing and stacking device.

    (a) Identification. An automated medium dispensing and stacking 
device is a device intended for medical purposes to dispense a 
microbiological culture medium into petri dishes and then mechanically 
stack the petri dishes.
    (b) Classification. Class I (general controls). This device is 
exempt from the premarket notification procedures in subpart E of part 
807. This device also is exempt from the good manufacturing practice 
regulation in part 820, with the exception of Sec. 820.180, with respect 
to general requirements concerning records, and Sec. 820.198, with 
respect to complaint files.



Sec. 866.2450  Supplement for culture media.

    (a) Identification. A supplement for culture media is a device, such 
as a vitamin or sugar mixture, that is added to a solid or liquid basal 
culture medium to produce a desired formulation and that is intended for 
medical purposes to enhance the growth of fastidious microorganisms 
(those having complex nutritional requirements). This device aids in the 
diagnosis of diseases caused by pathogenic microorganisms.
    (b) Classification. Class I. The device is exempt from the premarket 
notification procedures in subpart E of part 807 of this chapter.

[47 FR 50823, Nov. 9, 1982, as amended at 54 FR 25046, June 12, 1989]



Sec. 866.2480  Quality control kit for culture media.

    (a) Identification. A quality control kit for culture media is a 
device that consists of paper discs (or other suitable materials), each 
impregnated with a specified, freeze-dried, viable microorganism, 
intended for medical purposes to determine if a given culture medium is 
able to support the growth of that microorganism. The device aids in the 
diagnosis of disease caused by pathogenic microorganisms and also 
provides epidemiological information on these diseases.
    (b) Classification. Class I. The device is exempt from the premarket 
notification procedures in subpart E of part 807 of this chapter.

[47 FR 50823, Nov. 9, 1982, as amended at 54 FR 25046, June 12, 1989]



Sec. 866.2500  Microtiter diluting and dispensing device.

    (a) Identification. A microtiter diluting and dispensing device is a 
mechanical device intended for medical purposes to dispense or serially 
dilute very small quantities of biological or chemical reagents for use 
in various diagnostic procedures.
    (b) Classification. Class I. The device is exempt from the premarket 
notification procedures in subpart E of part 807 of this chapter.

[47 FR 50823, Nov. 9, 1982, as amended at 54 FR 25046, June 12, 1989]



Sec. 866.2540  Microbiological incubator.

    (a) Identification. A microbiological incubator is a device with 
various chambers or water-filled compartments in which controlled 
environmental conditions, particularly temperature, are maintained. It 
is intended for medical purposes to cultivate microorganisms and aid in 
the diagnosis of disease.
    (b) Classification. Class I (general controls). This device is 
exempt from premarket notification procedures in subpart E of part 807. 
The device also is exempt from the good manufacturing practice 
regulation in part 820 with the

[[Page 238]]

exception of Sec. 820.180, with respect to general requirements 
concerning records, and Sec. 820.198, with respect to complaint files.



Sec. 866.2560  Microbial growth monitor.

    (a) Identification. A microbial growth monitor is a device intended 
for medical purposes that measures the concentration of bacteria 
suspended in a liquid medium by measuring changes in light scattering 
properties, optical density, electrical impedance, or by making direct 
bacterial counts. The device aids in the diagnosis of disease caused by 
pathogenic microorganisms.
    (b) Classification. Class I. With the exception of automated blood 
culturing system devices that are used in testing for bacteria, fungi, 
and other microorganisms in blood and other normally sterile body 
fluids, this device is exempt from the premarket notification procedures 
in subpart E of part 807 of this chapter.

[47 FR 50823, Nov. 9, 1982, as amended at 60 FR 38482, July 27, 1995]



Sec. 866.2580  Gas-generating device.

    (a) Identification. A gas-generating device is a device intended for 
medical purposes that produces predetermined amounts of selected gases 
to be used in a closed chamber in order to establish suitable 
atmospheric conditions for cultivation of microorganisms with special 
atmospheric requirements. The device aids in the diagnosis of disease.
    (b) Classification. Class I. The device is exempt from the premarket 
notification procedures in subpart E of part 807 of this chapter.

[47 FR 50823, Nov. 9, 1982, as amended at 54 FR 25046, June 12, 1989]



Sec. 866.2600  Wood's fluorescent lamp.

    (a) Identification. A Wood's fluorescent lamp is a device intended 
for medical purposes to detect fluorescent materials (e.g., fluorescein 
pigment produced by certain microorganisms) as an aid in the 
identification of these microorganisms. The device aids in the diagnosis 
of disease.
    (b) Classification. Class I (general controls). The device is exempt 
from the premarket notification procedures in subpart E of part 807. The 
device also is exempt from the good manufacturing practice regulation in 
part 820 with the exception of Sec. 820.180, with respect to general 
requirements concerning records, and Sec. 820.198 with respect to 
complaint files.



Sec. 866.2660  Microorganism differentiation and identification device.

    (a) Identification. A microorganism differentiation and 
identification device is a device intended for medical purposes that 
consists of one or more components, such as differential culture media, 
biochemical reagents, and paper discs or paper strips impregnated with 
test reagents, that are usually contained in individual compartments and 
used to differentiate and identify selected microorganisms. The device 
aids in the diagnosis of disease.
    (b) Classification. Class I (general controls). The device is exempt 
from the premarket notification procedures in subpart E of part 807 of 
this chapter subject to Sec. 866.9.

[47 FR 50823, Nov. 9, 1982, as amended at 65 FR 2311, Jan. 14, 2000]



Sec. 866.2850  Automated zone reader.

    (a) Identification. An automated zone reader is a mechanical device 
intended for medical purposes to measure zone diameters of microbial 
growth inhibition (or exhibition), such as those observed on the surface 
of certain culture media used in disc-agar diffusion antimicrobial 
susceptibility tests. The device aids in decisionmaking respecting the 
treatment of disease.
    (b) Classification. Class I (general controls).



Sec. 866.2900  Microbiological specimen collection and transport device.

    (a) Identification. A microbiological specimen collection and 
transport device is a specimen collecting chamber intended for medical 
purposes to preserve the viability or integrity of microorganisms in 
specimens during storage of specimens after their collection and during 
their transport from the collecting area to the laboratory. The device 
may be labeled or otherwise represented as sterile. The device aids in 
the diagnosis of disease caused by pathogenic microorganisms.

[[Page 239]]

    (b) Classification. Class I (general controls).



                     Subpart D--Serological Reagents



Sec. 866.3010  Acinetobacter calcoaceticus serological reagents.

    (a) Identification. Acinetobacter calcoaceticus serological reagents 
are devices that consist of Acinetobacter calcoaceticus antigens and 
antisera used to identify this bacterium from cultured isolates derived 
from clinical specimens. The identification aids in the diagnosis of 
disease caused by the bacterium Acinetobacter calcoaceticus and provides 
epidemiological information on disease caused by this microorganism. 
This organism becomes pathogenic in patients with burns or with 
immunologic deficiency, and infection can result in sepsis (blood 
poisoning).
    (b) Classification. Class I. These devices are exempt from the 
premarket notification procedures in subpart E of part 807 of this 
chapter.

[47 FR 50823, Nov. 9, 1982, as amended at 54 FR 25046, June 12, 1989]



Sec. 866.3020  Adenovirus serological reagents.

    (a) Identification. Adenovirus serological reagents are devices that 
consist of antigens and antisera used in serological tests to identify 
antibodies to adenovirus in serum. Additionally, some of these reagents 
consist of adenovirus antisera conjugated with a fluorescent dye and are 
used to identify adenoviruses directly from clinical specimens. The 
identification aids in the diagnosis of disease caused by adenoviruses 
and provides epidemiological information on these diseases. Adenovirus 
infections may cause pharyngitis (inflammation of the throat), acute 
respiratory diseases, and certain external diseases of the eye (e.g., 
conjunctivitis).
    (b) Classification. Class I. These devices are exempt from the 
premarket notification procedures in subpart E of part 807 of this 
chapter.

[47 FR 50823, Nov. 9, 1982, as amended at 54 FR 25046, June 12, 1989]



Sec. 866.3035  Arizona spp. serological reagents.

    (a) Identification. Arizona spp. serological reagents are devices 
that consist of antisera and antigens used to identify Arizona spp. in 
cultured isolates derived from clinical specimens. The identification 
aids in the diagnosis of disease caused by bacteria belonging to the 
genus Arizona and provides epidemiological information on diseases 
caused by these microorganisms. Arizona spp. can cause gastroenteritis 
(food poisoning) and sepsis (blood poisoning).
    (b) Classification. Class I. These devices are exempt from the 
premarket notification procedures in subpart E of part 807 of this 
chapter.

[47 FR 50823, Nov. 9, 1982, as amended at 54 FR 25046, June 12, 1989]



Sec. 866.3040  Aspergillus spp. serological reagents.

    (a) Identification. Aspergillus spp. serological reagents are 
devices that consist of antigens and antisera used in various 
serological tests to identify antibodies to Aspergillus spp. in serum. 
The identification aids in the diagnosis of aspergillosis caused by 
fungi belonging to the genus Aspergillus. Aspergillosis is a disease 
marked by inflammatory granulomatous (tumor-like) lessions in the skin, 
ear, eyeball cavity, nasal sinuses, lungs, and occasionally the bones.
    (b) Classification. Class I (general controls). The device is exempt 
from the premarket notification procedures in subpart E of part 807 of 
this chapter subject to Sec. 866.9.

[47 FR 50823, Nov. 9, 1982, as amended at 65 FR 2311, Jan. 14, 2000]



Sec. 866.3060  Blastomyces dermatitidis serological reagents.

    (a) Identification. Blastomyces dermatitidis serological reagents 
are devices that consist of antigens and antisera used in serological 
tests to identify antibodies to Blastomyces determatitidis in serum. The 
identification aids in the diagnosis of blastomycosis caused by the 
fungus Blastomyces dermatitidis. Blastomycosis is a chronic 
granulomatous (tumor-like) disease, which may be limited to

[[Page 240]]

the skin or lung or may be widely disseminated in the body resulting in 
lesions of the bones, liver, spleen, and kidneys.
    (b) Classification. Class II (special controls). The device is 
exempt from the premarket notification procedures in subpart E of part 
807 of this chapter subject to Sec. 866.9.

[47 FR 50823, Nov. 9, 1982, as amended at 63 FR 59226, Nov. 3, 1998]



Sec. 866.3065  Bordetella spp. serological reagents.

    (a) Identification. Bordetella spp. serological reagents are devices 
that consist of antigens and antisera, including antisera conjugated 
with a fluorescent dye, used in serological tests to identify Bordetella 
spp. from cultured isolates or directly from clinical specimens. The 
identification aids in the diagnosis of diseases caused by bacteria 
belonging to the genus Bordetella and provides epidemiological 
information on these diseases. Bordetella spp. cause whooping cough 
(Bordetella pertussis) and other similiarly contagious and acute 
respiratory infections characterized by pneumonitis (inflammation of the 
lungs).
    (b) Classification. Class I. These devices are exempt from the 
premarket notification procedures in subpart E of part 807 of this 
chapter.

[47 FR 50823, Nov. 9, 1982, as amended at 54 FR 25046, June 12, 1989]



Sec. 866.3085  Brucella spp. serological reagents.

    (a) Identification. Brucella spp. serological reagents are devices 
that consist of antigens and antisera used for serological 
identification of Brucella spp. from cultured isolates derived from 
clinical specimens or to identify antibodies to Brucella spp. in serum. 
Additionally, some of these reagents consist of antisera conjugated with 
a fluorescent dye (immunofluorescent reagents) used to identify Brucella 
spp. directly from clinical specimens or cultured isolates derived from 
clinical specimens. The identification aids in the diagnosis of 
brucellosis (e.g., undulant fever, Malta fever) caused by bacteria 
belonging to the genus Brucella and provides epidemiological information 
on diseases caused by these microorganisms.
    (b) Classification. Class II (special controls). The device is 
exempt from the premarket notification procedures in subpart E of part 
807 of this chapter subject to Sec. 866.9.

[47 FR 50823, Nov. 9, 1982, as amended at 63 FR 59226, Nov. 3, 1998]



Sec. 866.3110  Campylobacter fetus serological reagents.

    (a) Identification. Campylobacter fetus serological reagents are 
devices that consist of antisera conjugated with a fluorescent dye used 
to identify Campylobacter fetus from clinical specimens or cultured 
isolates derived from clinical specimens. The identification aids in the 
diagnosis of diseases caused by this bacterium and provides 
epidemiological information on these diseases. Campylobacter fetus is a 
frequent cause of abortion in sheep and cattle and is sometimes 
responsible for endocarditis (inflammation of certain membranes of the 
heart) and enteritis (inflammation of the intestines) in humans.
    (b) Classification. Class I (general controls).



Sec. 866.3120  Chlamydia serological reagents.

    (a) Identification. Chlamydia serological reagents are devices that 
consist of antigens and antisera used in serological tests to identify 
antibodies to chlamydia in serum. Additionally, some of these reagents 
consist of chlamydia antisera conjugated with a fluorescent dye used to 
identify chlamydia directly from clinical specimens or cultured isolates 
derived from clinical specimens. The identification aids in the 
diagnosis of disease caused by bacteria belonging to the genus Chlamydia 
and provides epidemiological information on these diseases. Chlamydia 
are the causative agents of psittacosis (a form of pneumonia), 
lymphogranuloma venereum (a venereal disease), and trachoma (a chronic 
disease of the eye and eyelid).
    (b) Classification. Class I (general controls).

[[Page 241]]



Sec. 866.3125  Citrobacter spp. serological reagents.

    (a) Identification. Citrobacter spp. serological reagents are 
devices that consist of antigens and antisera used in serological tests 
to identify Citrobacter spp. from cultured isolates derived from 
clinical specimens. The identification aids in the diagnosis of disease 
caused by bacteria belonging to the genus Citrobacter and provides 
epidemiological information on diseases caused by these microorganisms. 
Citrobacter spp. have occasionally been associated with urinary tract 
infections.
    (b) Classification. Class I. These devices are exempt from the 
premarket notification procedures in subpart E of part 807 of this 
chapter.

[47 FR 50823, Nov. 9, 1982, as amended at 54 FR 25046, June 12, 1989]



Sec. 866.3135  Coccidioides immitis serological reagents.

    (a) Identification. Coccidioides immitis serological reagents are 
devices that consist of antigens and antisera used in serological tests 
to identify antibodies to Coccidioides immitis in serum. The 
identification aids in the diagnosis of coccidioidomycosis caused by a 
fungus belonging to the genus Coccidioides and provides epidemiological 
information on diseases caused by this microorganism. An infection with 
Coccidioides immitis produces symptoms varying in severity from those 
accompanying the common cold to those of influenza.
    (b) Classification. Class II (special controls). The device is 
exempt from the premarket notification procedures in subpart E of part 
807 of this chapter subject to Sec. 866.9.

[47 FR 50823, Nov. 9, 1982, as amended at 63 FR 59226, Nov. 3, 1998]



Sec. 866.3140  Corynebacterium spp. serological reagents.

    (a) Identification. Corynebacterium spp. serological reagents are 
devices that consist of antisera conjugated with a fluorescent dye used 
to identify Corynebacterium spp. from clinical specimens. The 
identification aids in the diagnosis of disease caused by bacteria 
belonging to the genus Corynebacterium and provides epidemiological 
information on diseases caused by these microorganisms. The principal 
human pathogen of this genus, Corynebacterium diphtheriae, causes 
diphtheria. However, many other types of corynebacteria form part of the 
normal flora of the human respiratory tract, other mucus membranes, and 
skin, and are either nonpathogenic or have an uncertain role.
    (b) Classification. Class I (general controls). The device is exempt 
from the premarket notification procedures in subpart E of part 807 of 
this chapter subject to Sec. 866.9.

[47 FR 50823, Nov. 9, 1982, as amended at 65 FR 2311, Jan. 14, 2000]



Sec. 866.3145  Coxsackievirus serological reagents.

    (a) Identification. Coxsackievirus serological reagents are devices 
that consist of antigens and antisera used in serological tests to 
identify antibodies to coxsackievirus in serum. Additionally, some of 
these reagents consist of coxsackievirus antisera conjugated with a 
fluorescent dye that are used to identify coxsackievirus from clinical 
specimens or from tissue culture isolates derived from clinical 
specimens. The identification aids in the diagnosis of coxsackievirus 
infections and provides epidemiological information on diseases caused 
by these viruses. Coxsackieviruses produce a variety of infections, 
including common colds, meningitis (inflammation of brain and spinal 
cord membranes), herpangina (brief fever accompanied by ulcerated 
lesions of the throat), and myopericarditis (inflammation of heart 
tissue).
    (b) Classification. Class I (general controls). The device is exempt 
from the premarket notification procedures in subpart E of part 807 of 
this chapter subject to Sec. 866.9.

[47 FR 50823, Nov. 9, 1982, as amended at 65 FR 2311, Jan. 14, 2000]



Sec. 866.3165  Cryptococcus neoformans serological reagents.

    (a) Identification. Cryptococcus neoformans serological reagents are 
devices that consist of antigens used in serological tests to identify 
antibodies to Cryptococcus neoformans in serum. Additionally, some of 
these reagents

[[Page 242]]

consist of antisera conjugated with a fluorescent dye (immunofluorescent 
reagents) and are used to identify Cryptococcus neoformans directly from 
clinical specimens or from cultured isolates derived from clinical 
specimens. The identification aids in the diagnosis of cryptococcosis 
and provides epidemiological information on this type of disease. 
Cryptococcosis infections are found most often as chronic meningitis 
(inflammation of brain membranes) and, if not treated, are usually 
fatal.
    (b) Classification. Class II (special controls). The device is 
exempt from the premarket notification procedures in subpart E of part 
807 of this chapter subject to Sec. 866.9.

[47 FR 50823, Nov. 9, 1982, as amended at 63 FR 59226, Nov. 3, 1998]



Sec. 866.3175  Cytomegalovirus serological reagents.

    (a) Identification. Cytomegalovirus serological reagents are devices 
that consist of antigens and antisera used in serological tests to 
identify antibodies to cytomegalovirus in serum. The identification aids 
in the diagnosis of diseases caused by cytomegaloviruses (principally 
cytomegalic inclusion disease) and provides epidemiological information 
on these diseases. Cytomegalic inclusion disease is a generalized 
infection of infants and is caused by intrauterine or early postnatal 
infection with the virus. The disease may cause severe congenital 
abnormalities, such as microcephaly (abnormal smallness of the head), 
motor disability, and mental retardation. Cytomegalovirus infection has 
also been associated with acquired hemolytic anemia, acute and chronic 
hepatitis, and an infectious mononucleosis-like syndrome.
    (b) Classification. Class II (performance standards).



Sec. 866.3200  Echinococcus spp. serological reagents.

    (a) Identification. Echinococcus spp. serological reagents are 
devices that consist of Echinococcus spp. antigens and antisera used in 
serological tests to identify antibodies to Echinococcus spp. in serum. 
The identification aids in the diagnosis of echinococcosis, caused by 
parasitic tapeworms belonging to the genus Echinococcus and provides 
epidemiological information on this disease. Echinococcosis is 
characterized by the development of cysts in the liver, lung, kidneys, 
and other organs formed by the larva of the infecting organisms.
    (b) Classification. Class I (general controls). The device is exempt 
from the premarket notification procedures in subpart E of part 807 of 
this chapter subject to Sec. 866.9.

[47 FR 50823, Nov. 9, 1982, as amended at 65 FR 2311, Jan. 14, 2000]



Sec. 866.3205  Echovirus serological reagents.

    (a) Identification. Echovirus serological reagents are devices that 
consist of antigens and antisera used in serological tests to identify 
antibodies to echovirus in serum. Additionally, some of these reagents 
consist of echovirus antisera conjugated with a fluorescent dye used to 
identify echoviruses from clinical specimens or from tissue culture 
isolates derived from clinical specimens. The identification aids in the 
diagnosis of echovirus infections and provides epidemiological 
information on diseases caused by these viruses. Echoviruses cause 
illnesses such as meningitis (inflammation of the brain and spinal cord 
membranes), febrile illnesses (accompanied by fever) with or without 
rash, and the common cold.
    (b) Classification. Class I. These devices are exempt from the 
premarket notification procedures in subpart E of part 807 of this 
chapter.

[47 FR 50823, Nov. 9, 1982, as amended at 54 FR 25046, June 12, 1989]



Sec. 866.3220  Entamoeba histolytica serological reagents.

    (a) Identification. Entamoeba histolytica serological reagents are 
devices that consist of antigens and antisera used in serological tests 
to identify antibodies to Entamoeba histolytica in serum. Additionally, 
some of these reagents consist of antisera conjugated with a fluorescent 
dye (immunofluorescent reagents) used to identify Entamoeba histolytica 
directly

[[Page 243]]

from clinical specimens. The identification aids in the diagnosis of 
amebiasis caused by the microscopic protozoan parasite Entamoeba 
histolytica and provides epidemiological information on diseases caused 
by this parasite. The parasite may invade the skin, liver, intestines, 
lungs, and diaphragm, causing disease conditions such as indolent 
ulcers, an amebic hepatitis, amebic dysentery, and pulmonary lesions.
    (b) Classification. Class II (special controls). The device is 
exempt from the premarket notification procedures in subpart E of part 
807 of this chapter subject to Sec. 866.9.

[47 FR 50823, Nov. 9, 1982; 47 FR 56846, Dec. 21, 1982, as amended at 63 
FR 59226, Nov. 3, 1998]



Sec. 866.3235  Epstein-Barr virus serological reagents.

    (a) Identification. Epstein-Barr virus serological reagents are 
devices that consist of antigens and antisera used in serological tests 
to identify antibodies to Epstein-Barr virus in serum. The 
identification aids in the diagnosis of Epstein-Barr virus infections 
and provides epidemiological information on diseases caused by these 
viruses. Epstein-Barr viruses are thought to cause infectious 
mononucleosis and have been associated with Burkitt's lymphoma (a tumor 
of the jaw in African children and young adults) and postnasal carcinoma 
(cancer).
    (b) Classification. Class I (general controls).



Sec. 866.3240  Equine encephalomyelitis virus serological reagents.

    (a) Identification. Equine encephalomyelitis virus serological 
reagents are devices that consist of antigens and antisera used in 
serological tests to identify antobodies to equine encephalomyelitis 
virus in serum. The identification aids in the diagnosis of diseases 
caused by equine encephalomyelitis viruses and provides epidemiological 
information on these viruses. Equine encephalomyelitis viruses are 
transmitted to humans by the bite of insects, such as mosquitos and 
ticks, and may cause encephalitis (inflammation of the brain), rash, 
acute arthritis, or hepatitis.
    (b) Classification. Class I (general controls). The device is exempt 
from the premarket notification procedures in subpart E of part 807 of 
this chapter subject to Sec. 866.9.

[47 FR 50823, Nov. 9, 1982, as amended at 65 FR 2311, Jan. 14, 2000]



Sec. 866.3250  Erysipelothrix rhusiopathiae serological reagents.

    (a) Identification. Erysipelothrix rhusiopathiae serological 
reagents are devices that consist of antigens and antisera used in 
serological tests to identify Erysipelothrix rhusiopathiae from cultured 
isolates derived from clinical specimens. The identification aids in the 
diagnosis of disease caused by this bacterium belonging to the genus 
Erysipelothrix. This organism is responsible for a variety of 
inflammations of the skin following skin abrasions from contact with 
fish, shellfish, or poultry.
    (b) Classification. Class I. These devices are exempt from the 
premarket notification procedures in subpart E of part 807 of this 
chapter.

[47 FR 50823, Nov. 9, 1982, as amended at 54 FR 25046, June 12, 1989]



Sec. 866.3255  Escherichia coli serological reagents.

    (a) Identification. Escherichia coli serological reagents are 
devices that consist of antigens and antisera used in serological tests 
to identify Escherichia coli from cultured isolates derived from 
clinical specimens. Additionally, some of these reagents consist of 
Escherichia coli antisera conjugated with a fluorescent dye used to 
identify Escherichia coli directly from clinical specimens or cultured 
isolates derived from clinical specimens. The identification aids in the 
diagnosis of diseases caused by this bacterium belonging to the genus 
Escherichia, and provides epidemiological information on diseases caused 
by this microorganism. Although Escherichia coli constitutes the greater 
part of the microorganisms found in the intestinal tract in humans and 
is usually nonpathogenic, those strains which are pathogenic may cause 
urinary tract infections or epidemic diarrheal disease, especially in 
children.
    (b) Classification. Class I. These devices are exempt from the 
premarket

[[Page 244]]

notification procedures in subpart E of part 807 of this chapter.

[47 FR 50823, Nov. 9, 1982, as amended at 54 FR 25046, June 12, 1989]



Sec. 866.3270  Flavobacterium spp. serological reagents.

    (a) Identification. Flavobacterium spp. serological reagents are 
devices that consist of antigens and antisera used in serological tests 
to identify Flavobacteriuim spp. from cultured isolates derived from 
clinical specimens. The identification aids in the diagnosis of disease 
caused by bacteria belonging to the genus Flavobacterium and provides 
epidemiological information on diseases caused by these microorganisms. 
Most members of this genus are found in soil and water and, under 
certain conditions, may become pathogenic to humans. Flavobacterium 
meningosepticum is highly virulent for the newborn, in whom it may cause 
epidemics of septicemia (blood poisoning) and meningitis (inflammation 
of the membranes of the brain) and is usually attributable to 
contaminated hospital equipment.
    (b) Classification. Class I. These devices are exempt from the 
premarket notification procedures in subpart E of part 807 of this 
chapter.

[47 FR 50823, Nov. 9, 1982, as amended at 54 FR 25046, June 12, 1989]



Sec. 866.3280  Francisella tularensis serological reagents.

    (a) Identification. Francisella tularensis serological reagents are 
devices that consist of antigens and antisera used in serological tests 
to identify antibodies to Francisella tularensis in serum or to identify 
Francisella tularensis in cultured isolates derived from clinical 
specimens. Additionally, some of these reagents consist of antisera 
conjugated with a fluorescent dye (immunofluorescent reagents) used to 
identify Francisella tularensis directly from clinical specimens. The 
identification aids in the diagnosis of tularemia caused by Francisella 
tularensis and provides epidemiological information on this disease. 
Tularemia is a desease principally of rodents, but may be transmitted to 
humans through handling of infected animals, animal products, or by the 
bites of fleas and ticks. The disease takes on several forms depending 
upon the site of infection, such as skin lesions, lymph node 
enlargements, or pulmonary infection.
    (b) Classification. Class II (special controls). The device is 
exempt from the premarket notification procedures in subpart E of part 
807 of this chapter subject to Sec. 866.9.

[47 FR 50823, Nov. 9, 1982, as amended at 63 FR 59226, Nov. 3, 1998]



Sec. 866.3290  Gonococcal antibody test (GAT).

    (a) Identification. A gonococcal antibody test (GAT) is an in vitro 
device that consists of the reagents intended to identify by 
immunochemical techniques, such as latex agglutination, indirect 
fluorescent antibody, or radioimmunoassay, antibodies to Neisseria 
gonorrhoeae in sera of asymptomatic females at low risk of infection. 
Identification of antibodies with this device may indicate past or 
present infection of the patient with Neisseria gonorrhoeae.
    (b) Classification. Class III (premarket approval) (transitional 
device).
    (c) Date PMA or notice of completion of a PDP is required. As of May 
28, 1976, an approval under section 515 of the act is required before 
this device may be commercially distributed. See Sec. 866.3.

[47 FR 50823, Nov. 9, 1982, as amended at 52 FR 17734, May 11, 1987]



Sec. 866.3300  Haemophilus spp. serological reagents.

    (a) Identification. Haemophilus spp. serological reagents are 
devices that consist of antigens and antisera, including antisera 
conjugated with a fluorescent dye, that are used in serological tests to 
identify Haemophilus spp. directly from clinical specimens or tissue 
culture isolates derived from clinical specimens. The identification 
aids in the diagnosis of diseases caused by bacteria belonging to the 
genus Haemophilus and provides epidemiological information on diseases 
cause by these microorganisms. Diseases most often caused by Haemophilus 
spp. include pneumonia, pharyngitis, sinusitis, vaginitis, chancroid 
venereal disease, and a contagious form of conjunctivitis (inflammation 
of eyelid membranes).

[[Page 245]]

    (b) Classification. Class II (special controls). The device is 
exempt from the premarket notification procedures in subpart E of part 
807 of this chapter subject to Sec. 866.9.

[47 FR 50823, Nov. 9, 1982, as amended at 63 FR 59226, Nov. 3, 1998]



Sec. 866.3305  Herpes simplex virus serological reagents.

    (a) Identification. Herpes simplex virus serological reagents are 
devices that consist of antigens and antisera used in various 
serological tests to identify antibodies to herpes simplex virus in 
serum. Additionally, some of the reagents consist of herpes simplex 
virus antisera conjugated with a fluorescent dye (immunofluorescent 
reagents) used to identify herpes simplex virus directly from clinical 
specimens or tissue culture isolates derived from clinical specimens. 
The identification aids in the diagnosis of diseases caused by herpes 
simplex viruses and provides epidemiological information on these 
diseases. Herpes simplex viral infections range from common and mild 
lesions of the skin and mucous membranes to a severe form of 
encephalitis (inflammation of the brain). Neonatal herpes virus 
infections range from an mild infection to a severe generalized disease 
with a fatal outcome.
    (b) Classification. Class III (premarket approval).
    (c) Date PMA or notice of completion of a PDP is required. No 
effective date has been established of the requirement for premarket 
approval. See Sec. 866.3.

[47 FR 50823, Nov. 9, 1982, as amended at 52 FR 17734, May 11, 1987]



Sec. 866.3320  Histoplasma capsulatum serological reagents.

    (a) Identification. Histoplasma capsulatum serological reagents are 
devices that consist of antigens and antisera used in serological tests 
to identify antibodies to Histoplasma capsulatum in serum. Additionally, 
some of these reagents consist of Histoplasma capsulatum antisera 
conjugated with a fluorescent dye (immunofluorescent reagents) used to 
identify Histoplasma capsulatum from clinical specimens or cultured 
isolates derived from clinical specimens. The identification aids in the 
diagnosis of histoplasmosis caused by this fungus belonging to the genus 
Histoplasma and provides epidemiological information on the diseases 
caused by this fungus. Histoplasmosis usually is a mild and often 
asymptomatic respiratory infection, but in a small number of infected 
individuals the lesions may spread to practically all tissues and 
organs.
    (b) Classification. Class II (special controls). The device is 
exempt from the premarket notification procedures in subpart E of part 
807 of this chapter subject to Sec. 866.9.

[47 FR 50823, Nov. 9, 1982, as amended at 63 FR 59227, Nov. 3, 1998]



Sec. 866.3330  Influenza virus serological reagents.

    (a) Identification. Influenza virus serological reagents are devices 
that consist of antigens and antisera used in serological tests to 
identify antibodies to influenza in serum. The identification aids in 
the diagnosis of influenza (flu) and provides epidemiological 
information on influenza. Influenza is an acute respiratory tract 
disease, which is often epidemic.
    (b) Classification. Class I. These devices are exempt from the 
premarket notification procedures in subpart E of part 807 of this 
chapter.

[47 FR 50823, Nov. 9, 1982, as amended at 54 FR 25047, June 12, 1989]



Sec. 866.3340  Klebsiella spp. serological reagents.

    (a) Identification. Klebsiella spp. serological reagents are devices 
that consist of antigens and antisera, including antisera conjugated 
with a fluorescent dye (immunofluorescent reagents), that are used in 
serological tests to identify Klebsiella spp. from cultured isolates 
derived from clinical specimens. The identification aids in the 
diagnosis of diseases caused by bacteria belonging to the genus 
Klebsiella and provides epidemiological information on these diseases. 
These organisms can cause serious urinary tract and pulmonary 
infections, particularly in hospitalized patients.
    (b) Classification. Class I. These devices are exempt from the 
premarket

[[Page 246]]

notification procedures in subpart E of part 807 of this chapter.

[47 FR 50823, Nov. 9, 1982, as amended at 54 FR 25047, June 12, 1989]



Sec. 866.3350  Leptospira spp. serological reagents.

    (a) Identification. Leptospira spp. serological reagents are devices 
that consist of antigens and antisera used in serological tests to 
identify antibodies to Leptospira spp. in serum or identify Leptospira 
spp. from cultured isolates derived from clinical specimens. 
Additionally, some of these antisera are conjugated with a fluorescent 
dye (immunofluorescent reagents) and used to identify Leptospira spp. 
directly from clinical specimens. The identification aids in the 
diagnosis of leptospirosis caused by bacteria belonging to the genus 
Leptospira and provides epidemiological information on this disease. 
Leptospira infections range from mild fever-producing illnesses to 
severe liver and kidney involvement producing hemorrhage and dysfunction 
of these organs.
    (b) Classification. Class II (special controls). The device is 
exempt from the premarket notification procedures in subpart E of part 
807 of this chapter subject to Sec. 866.9.

[47 FR 50823, Nov. 9, 1982, as amended at 63 FR 59227, Nov. 3, 1998]



Sec. 866.3355  Listeria spp. serological reagents.

    (a) Identification. Listeria spp. serological reagents are devices 
that consist of antigens and antisera used in serological tests to 
identify Listeria spp. from cultured isolates derived from clinical 
specimens. Additionally, some of these reagents consist of Listeria spp. 
antisera conjugated with a fluorescent dye (immunofluorescent reagents) 
used to identify Listeria spp. directly from clinical specimens. The 
identification aids in the diagnosis of listeriosis, a disease caused by 
bacteria belonging to the genus Listeria, and provides epidemiological 
information on diseases caused by these microorganisms. Listeria 
monocytogenes, the most common human pathogen of this genus, causes 
meningitis (inflammation of the brain membranes) and meningoencephalitis 
(inflammation of the brain and brain membranes) and is often fatal if 
untreated. A second form of human listeriosis is an intrauterine 
infection in pregnant women that results in a high mortality rate for 
infants before or after birth.
    (b)  Classification. Class I (general controls). The device is 
exempt from the premarket notification procedures in subpart E of part 
807 of this chapter subject to Sec. 866.9.

[47 FR 50823, Nov. 9, 1982, as amended at 65 FR 2311, Jan. 14, 2000]



Sec. 866.3360  Lymphocytic choriomeningitis virus serological reagents.

    (a) Identification. Lymphocytic choriomeningitis virus serological 
reagents are devices that consist of antigens and antisera used in 
serological tests to identify antibodies to lymphocytic choriomeningitis 
virus in serum. The identification aids in the diagnosis of lymphocytic 
choriomeningitis virus infections and provides epidemiological 
information on diseases caused by these viruses. Lymphocytic 
choriomeningitis viruses usually cause a mild cerebral meningitis 
(inflammation of membranes that envelop the brain) and occasionally a 
mild pneumonia, but in rare instances may produce severe and even fatal 
illnesses due to complications from cerebral meningitis and pneumonia.
    (b) Classification. Class I (general controls). The device is exempt 
from the premarket notification procedures in subpart E of part 807 of 
this chapter subject to Sec. 866.9.

[47 FR 50823, Nov. 9, 1982, as amended at 65 FR 2311, Jan. 14, 2000]



Sec. 866.3370  Mycobacterium tuberculosis immunofluorescent reagents.

    (a) Identification. Mycobacterium tuberculosis immunofluorescent 
reagents are devices that consist of antisera conjugated with a 
fluorescent dye used to identify Mycobacterium tuberculosis directly 
from clinical specimens. The identification aids in the diagnosis of 
tuberculosis and provides epidemiological information on this disease. 
Mycobacterium tuberculosis is the common causative organism in human 
tuberculosis, a chronic infectious disease characterized by formation of 
tubercles

[[Page 247]]

(small rounded nodules) and tissue necrosis (destruction), usually 
occurring in the lung.
    (b) Classification. Class I (general controls).



Sec. 866.3375  Mycoplasma spp. serological reagents.

    (a) Identification. Mycoplasma spp. serological reagents are devices 
that consist of antigens and antisera used in serological tests to 
identify antibodies to Mycoplasma spp. in serum. Additionally, some of 
these reagents consist of Mycoplasma spp. antisera conjugated with a 
fluorescent dye (immunofluorescent reagents) used to identify Mycoplasma 
spp. directly from clinical specimens. The identification aids in the 
diagnosis of disease caused by bacteria belonging to the genus 
Mycoplasma and provides epidemiological information on diseases caused 
by these microorganisms. Mycoplasma spp. are associated with 
inflammatory conditions of the urinary and respiratory tracts, the 
genitals, and the mouth. The effects in humans of infection with 
Mycoplasma pneumoniae range from inapparent infection to mild or severe 
upper respiratory disease, ear infection, and bronchial pneumonia.
    (b) Classification. Class I (general controls). The device is exempt 
from the premarket notification procedures in subpart E of part 807 of 
this chapter subject to Sec. 866.9.

[47 FR 50823, Nov. 9, 1982, as amended at 65 FR 2311, Jan. 14, 2000]



Sec. 866.3380  Mumps virus serological reagents.

    (a) Identification. Mumps virus serological reagents consist of 
antigens and antisera used in serological tests to identify antibodies 
to mumps virus in serum. Additionally, some of these reagents consist of 
antisera conjugated with a fluorescent dye (immunofluorescent reagents) 
used in serological tests to identify mumps viruses from tissue culture 
isolates derived from clinical specimens. The identification aids in the 
diagnosis of mumps and provides epidemiological information on mumps. 
Mumps is an acute contagious disease, particularly in children, 
characterized by an enlargement of one or both of the parotid glands 
(glands situated near the ear), although other organs may also be 
involved.
    (b) Classification. Class I (general controls). The device is exempt 
from the premarket notification procedures in subpart E of part 807 of 
this chapter subject to Sec. 866.9.

[47 FR 50823, Nov. 9, 1982, as amended at 65 FR 2311, Jan. 14, 2000]



Sec. 866.3390  Neisseria spp. direct serological test reagents.

    (a) Identification. Neisseria spp. direct serological test reagents 
are devices that consist of antigens and antisera used in serological 
tests to identify Neisseria spp. from cultured isolates. Additionally, 
some of these reagents consist of Neisseria spp. antisera conjugated 
with a fluorescent dye (immunofluorescent reagents) which may be used to 
detect the presence of Neisseria spp. directly from clinical specimens. 
The identification aids in the diagnosis of disease caused by bacteria 
belonging to the genus Neisseria, such as epidemic cerebrospinal 
meningitis, meningococcal disease, and gonorrhea, and also provides 
epidemiological information on diseases caused by these microorganisms. 
The device does not include products for the detection of gonorrhea in 
humans by indirect methods, such as detection of antibodies or of 
oxidase produced by gonococcal organisms.
    (b) Classification. Class II (performance standards).



Sec. 866.3400  Parainfluenza virus serological reagents.

    (a) Identification. Parainfluenza virus serological reagents are 
devices that consist of antigens and antisera used in serological tests 
to identify antibodies to parainfluenza virus in serum. The 
identification aids in the diagnosis of parainfluenza virus infections 
and provides epidemiological information on diseases caused by these 
viruses. Parainfluenza viruses cause a variety of respiratory illnesses 
ranging from the common cold to pneumonia.
    (b) Classification. Class I. These devices are exempt from the 
premarket

[[Page 248]]

notification procedures in subpart E of part 807 of this chapter.

[47 FR 50823, Nov. 9, 1982, as amended at 54 FR 25047, June 12, 1989]



Sec. 866.3405  Poliovirus serological reagents.

    (a) Identification. Poliovirus serological reagents are devices that 
consist of antigens and antisera used in serological tests to identify 
antibodies to poliovirus in serum. Additionally, some of these reagents 
consist of poliovirus antisera conjugated with a fluorescent dye 
(immunofluorescent reagents) used to identify polioviruses from clinical 
specimens or from tissue culture isolates derived from clinical 
specimens. The identification aids in the diagnosis of poliomyelitis 
(polio) and provides epidemiological information on this disease. 
Poliomyelitis is an acute infectious disease which in its serious form 
affects the central nervous system resulting in atrophy (wasting away) 
of groups of muscles, ending in contraction and permanent deformity.
    (b) Classification. Class I (general controls). The device is exempt 
from the premarket notification procedures in subpart E of part 807 of 
this chapter subject to Sec. 866.9.

[47 FR 50823, Nov. 9, 1982, as amended at 65 FR 2312, Jan. 14, 2000]



Sec. 866.3410  Proteus spp. (Weil-Felix) serological reagents.

    (a) Identification. Proteus spp. (Weil-Felix) serological reagents 
are devices that consist of antigens and antisera, including antisera 
conjugated with a fluorescent dye (immunofluorescent reagents), derived 
from the bacterium Proteus vulgaris used in agglutination tests (a 
specific type of antigen-antibody reaction) for the detection of 
antibodies to rickettsia (virus-like bacteria) in serum. Test results 
aid in the diagnosis of diseases caused by bacteria belonging to the 
genus Rickettsiae and provide epidemiological information on these 
diseases. Rickettsia are generally transmitted by arthropods (e.g., 
ticks and mosquitoes) and produce infections in humans characterized by 
rash and fever (e.g., typhus fever, spotted fever, Q fever, and trench 
fever).
    (b) Classification. Class I. These devices are exempt from the 
premarket notification procedures in subpart E of part 807 of this 
chapter.

[47 FR 50823, Nov. 9, 1982, as amended at 54 FR 25047, June 12, 1989]



Sec. 866.3415  Pseudomonas spp. serological reagents.

    (a) Identification. Pseudomonas spp. serological reagents are 
devices that consist of antigens and antisera, including antisera 
conjugated with a fluorescent dye (immunofluorescent reagents), used to 
identify Pseudomonas spp. from clinical specimens or from cultured 
isolates derived from clinical specimens. The identification aids in the 
diagnosis of disease caused by bacteria belonging to the genus 
Pseudomonas. Pseudomonas aeruginosa is a major cause of hospital-
acquired infections, and has been associated with urinary tract 
infections, eye infections, burn and wound infections, blood poisoning, 
abscesses, and meningitis (inflammation of brain membranes). Pseudomonas 
pseudomallei causes melioidosis, a chronic pneumonia.
    (b) Classification. Class II (special controls). The device is 
exempt from the premarket notification procedures in subpart E of part 
807 of this chapter subject to Sec. 866.9.

[47 FR 50823, Nov. 9, 1982, as amended at 63 FR 59227, Nov. 3, 1998]



Sec. 866.3460  Rabiesvirus immunofluorescent reagents.

    (a) Identification. Rabiesvirus immunofluorescent reagents are 
devices that consist of rabiesvirus antisera conjugated with a 
fluorescent dye used to identify rabiesvirus in specimens taken from 
suspected rabid animals. The identification aids in the diagnosis of 
rabies in patients exposed by animal bites and provides epidemiological 
information on rabies. Rabies is an acute infectious disease of the 
central nervous system which, if undiagnosed, may be fatal. The disease 
is commonly transmitted to humans by a bite from a rabid animal.
    (b) Classification. Class II (performance standards).



Sec. 866.3470  Reovirus serological reagents.

    (a) Identification. Reovirus serological reagents are devices that 
consist of

[[Page 249]]

antigens and antisera used in serological tests to identify antibodies 
to reovirus in serum. The identification aids in the diagnosis of 
reovirus infections and provides epidemiological information on diseases 
caused by these viruses. Reoviruses are thought to cause only mild 
respiratory and gastrointestinal illnesses.
    (b) Classification. Class I. These devices are exempt from premarket 
notification procedures in subpart E of part 807 of this chapter.

[47 FR 50823, Nov. 9, 1982, as amended at 54 FR 25047, June 12, 1989]



Sec. 866.3480  Respiratory syncytial virus serological reagents.

    (a) Identification. Respiratory syncytial virus serological reagents 
are devices that consist of antigens and antisera used in serological 
tests to identify antibodies to respiratory syncytial virus in serum. 
Additionally, some of these reagents consist of respiratory syncytial 
virus antisera conjugated with a fluorescent dye (immunofluorescent 
reagents) and used to identify respiratory syncytial viruses from 
clinical specimens or from tissue culture isolates derived from clinical 
specimens. The identification aids in the diagnosis of respiratory 
syncytial virus infections and provides epidemiological information on 
diseases caused by these viruses. Respiratory syncytial viruses cause a 
number of respiratory tract infections, including the common cold, 
pharyngitis, and infantile bronchopneumonia.
    (b) Classification. Class I (general controls). The device is exempt 
from the premarket notification procedures in subpart E of part 807 of 
this chapter subject to Sec. 866.9.

[47 FR 50823, Nov. 9, 1982, as amended at 65 FR 2312, Jan. 14, 2000]



Sec. 866.3490  Rhinovirus serological reagents.

    (a) Identification. Rhinovirus serological reagents are devices that 
consist of antigens and antisera used in serological tests to identify 
antibodies to rhinovirus in serum. The identification aids in the 
diagnosis of rhinovirus infections and provides epidemiological 
information on diseases caused by these viruses. Rhinoviruses cause 
common colds.
    (b) Classification. Class I. These devices are exempt from the 
premarket notification procedures in subpart E of part 807 of this 
chapter.

[47 FR 50823, Nov. 9, 1982, as amended at 54 FR 25047, June 12, 1989]



Sec. 866.3500  Rickettsia serological reagents.

    (a) Identification. Rickettsia serological reagents are devices that 
consist of antigens and antisera used in serological tests to identify 
antibodies to rickettsia in serum. Additionally, some of these reagents 
consist of rickettsial antisera conjugated with a fluorescent dye 
(immunofluorescent reagents) used to identify rickettsia directly from 
clinical specimens. The identification aids in the diagnosis of diseases 
caused by virus-like bacteria belonging to the genus Rickettsiae and 
provides epidemiological information on these diseases. Rickettsia are 
generally transmitted by arthropods (e.g., ticks and mosquitoes) and 
produce infections in humans characterized by rash and fever (e.g., 
typhus fever, spotted fever, Q fever, and trench fever).
    (b) Classification. Class I (general controls). The device is exempt 
from the premarket notification procedures in subpart E of part 807 of 
this chapter subject to Sec. 866.9.

[47 FR 50823, Nov. 9, 1982, as amended at 65 FR 2312, Jan. 14, 2000]



Sec. 866.3510  Rubella virus serological reagents.

    (a) Identification. Rubella virus serological reagents are devices 
that consist of antigens and antisera used in serological tests to 
identify antibodies to rubella virus in serum. The identification aids 
in the diagnosis of rubella (German measles) or confirmation of a 
person's immune status from past infections or immunizations and 
provides epidemiological information on German measles. Newborns 
infected in the uterus with rubella virus may be born with multiple 
congenital defects (rubella syndrome).
    (b) Classification. Class II. The special controls for this device 
are:
    (1) National Committee for Clinical Laboratory Standards':

[[Page 250]]

    (i) 1/LA6 ``Detection and Quantitation of Rubella IgG Antibody: 
Evaluation and Performance Criteria for Multiple Component Test 
Products, Speciment Handling, and Use of the Test Products in the 
Clinical Laboratory, October 1997,''
    (ii) 1/LA18 ``Specifications for Immunological Testing for 
Infectious Diseases, December 1994,''
    (iii) D13 ``Agglutination Characteristics, Methodology, Limitations, 
and Clinical Validation, October 1993,''
    (iv) EP5 ``Evaluation of Precision Performance of Clinical Chemistry 
Devices, February 1999,'' and
    (v) EP10 ``Preliminary Evaluation of the Linearity of Quantitive 
Clinical Laboratory Methods, May 1998,''
    (2) Centers for Disease Control's:
    (i) Low Titer Rubella Standard,
    (ii) Reference Panel of Well Characterized Rubella Sera, and
    (3) World Health Organization's International Rubella Standard.

[47 FR 50823, Nov. 9, 1982, as amended at 52 FR 17734, May 11, 1987; 65 
FR 17144, Mar. 31, 2000]

    Effective Date Note: At 65 FR 17144, Mar. 31, 2000, Sec. 866.3510 
was amended by revising paragraph (b) and by removing paragraph (c), 
effective May 1, 2000. For the convenience of the user, the superseded 
text follows.

Sec. 866.3510  Rubella virus serological reagents.

                                * * * * *

    (b) Classification. Class III (premarket approval).
    (c) Date PMA or notice of completion of a PDP is required. No 
effective date has been established of the requirement for premarket 
approval. See Sec. 866.3.



Sec. 866.3520  Rubeola (measles) virus serological reagents.

    (a) Identification. Rubeola (measles) virus serological reagents are 
devices that consist of antigens and antisera used in serological tests 
to identify antibodies to rubeola virus in serum. The identification 
aids in the diagnosis of measles and provides epidemiological 
information on the disease. Measles is an acute, highly infectious 
disease of the respiratory and reticuloendothelial tissues, particularly 
in children, characterized by a confluent and blotchy rash.
    (b) Classification. Class I. These devices are exempt from the 
premarket notification procedures in subpart E of part 807 of this 
chapter.

[47 FR 50823, Nov. 9, 1982, as amended at 54 FR 25047, June 12, 1989]



Sec. 866.3550  Salmonella spp. serological reagents.

    (a) Identification. Salmonella spp. serological reagents are devices 
that consist of antigens and antisera used in serological tests to 
identify Salmonella spp. from cultured isolates derived from clinical 
specimens. Additionally, some of these reagents consist of antisera 
conjugated with a fluorescent dye (immunofluorescent reagents) used to 
identify Salmonella spp. directly from clinical specimens or cultured 
isolates derived from clinical specimens. The identification aids in the 
diagnosis of salmonellosis caused by bacteria belonging to the genus 
Salmonella and provides epidemiological information on this disease. 
Salmonellosis is characterized by high grade fever (``enteric fever''), 
severe diarrhea, and cramps.
    (b) Classification. Class II (special controls). The device is 
exempt from the premarket notification procedures in subpart E of part 
807 of this chapter subject to Sec. 866.9.

[47 FR 50823, Nov. 9, 1982, as amended at 63 FR 59227, Nov. 3, 1998]



Sec. 866.3600  Schistosoma spp. serological reagents.

    (a) Identification. Schistosoma spp. serological reagents are 
devices that consist of antigens and antisera used in serological tests 
to identify antibodies to Schistosoma spp. in serum. The identification 
aids in the diagnosis of schistosomiasis caused by parasitic flatworms 
of the genus Schistosoma. Schistosomiasis is characterized by a variety 
of acute and chronic infections. Acute infection is marked by fever, 
allergic symptoms, and diarrhea. Chronic effects are usually severe and 
are caused by fibrous degeneration of tissue around deposited eggs of 
the parasite in the liver, lungs, and central nervous system. 
Schistosomes can also cause schistosome dermatitis (e.g., swimmer's 
itch), a skin disease marked by intense itching.

[[Page 251]]

    (b) Classification. Class I (general controls). The device is exempt 
from the premarket notification procedures in subpart E of part 807 of 
this chapter subject to Sec. 866.9.

[47 FR 50823, Nov. 9, 1982, as amended at 65 FR 2312, Jan. 14, 2000]



Sec. 866.3630  Serratia spp. serological reagents.

    (a) Identification. Serratia spp. serological reagents are devices 
that consist of antigens and antisera used in serological tests to 
identify Serratia spp. from cultured isolates. The identification aids 
in the diagnosis of disease caused by bacteria belonging to the genus 
Serratia and provides epidemiological information on these diseases. 
Serratia spp. are occasionally associated with gastroenteritis (food 
poisoning) and wound infections.
    (b) Classification. Class I. These devices are exempt from the 
premarket notification procedures in subpart E of part 807 of this 
chapter.

[47 FR 50823, Nov. 9, 1982 as amended at 54 FR 25047, June 12, 1989]



Sec. 866.3660  Shigella spp. serological reagents.

    (a) Identification. Shigella spp. serological reagents are devices 
that consist of antigens and antisera, including antisera conjugated 
with a fluorescent dye (immunofluorescent reagents), used in serological 
tests to identify Shigella spp. from cultured isolates. The 
identification aids in the diagnosis of shigellosis caused by bacteria 
belonging to the genus Shigella and provides epidemiological information 
on this disease. Shigellosis is characterized by abdominal pain, cramps, 
diarrhea, and fever.
    (b) Classification. Class II (special controls). The device is 
exempt from the premarket notification procedures in subpart E of part 
807 of this chapter subject to Sec. 866.9.

[47 FR 50823, Nov. 9, 1982, as amended at 63 FR 59227, Nov. 3, 1998]



Sec. 866.3680  Sporothrix schenckii serological reagents.

    (a) Identification. Sporothrix schenckii serological reagents are 
devices that consist of antigens and antisera used in serological tests 
to identify antibodies to Sporothrix schenckii in serum. The 
identification aids in the diagnosis of sporothrichosis caused by a 
fungus belonging to the genus Sporothrix and provides epidemiological 
information on this disease. Sporothrichosis is a chronic tumorlike 
infection primarily of the skin.
    (b) Classification. Class I (general controls). The device is exempt 
from the premarket notification procedures in subpart E of part 807 of 
this chapter subject to Sec. 866.9.

[47 FR 50823, Nov. 9, 1982, as amended at 65 FR 2312, Jan. 14, 2000]



Sec. 866.3700  Staphylococcus aureus serological reagents.

    (a) Identification. Staphylococcus aureus serological reagents are 
devices that consist of antigens and antisera used in serological tests 
to identify enterotoxin (toxin affecting the intestine) producing 
staphylococci from cultured isolates. The identification aids in the 
diagnosis of disease caused by this bacterium belonging to the genus 
Staphylococcus and provides epidemiological information on these 
diseases. Certain strains of Staphylococcus aureus produce an 
enterotoxin while growing in meat, dairy, or bakery products. After 
ingestion, this enterotoxin is absorbed in the gut and causes 
destruction of the intestinal lining (gastroenteritis).
    (b) Classification. Class I. These devices are exempt from the 
premarket notification procedures in subpart E of part 807 of this 
chapter.

[47 FR 50823, Nov. 9, 1982, as amended at 54 FR 25047, June 12, 1989]



Sec. 866.3720  Streptococcus spp. exoenzyme reagents.

    (a) Identification. Streptococcus spp. exoenzyme reagents are 
devices used to identify antibodies to Streptococcus spp. exoenzyme in 
serum. The identification aids in the diagnosis of disease caused by 
bacteria belonging to the genus Streptococcus and provides 
epidemiological information on these diseases. Pathogenic streptococci 
are associated with infections, such as sore throat, impetigo (an 
infection characterized by small pustules on the skin),

[[Page 252]]

urinary tract infections, rheumatic fever, and kidney disease.
    (b) Classification. Class I. The device is exempt from the premarket 
notification procedures in subpart E of part 807 of this chapter.

[47 FR 50823, Nov. 9, 1982, as amended at 61 FR 1119, Jan. 16, 1996]



Sec. 866.3740  Streptococcus spp. serological reagents.

    (a) Identification. Streptococcus spp. serological reagents are 
devices that consist of antigens and antisera (excluding streptococcal 
exoenzyme reagents made from enzymes secreted by streptococci) used in 
serological tests to identify Streptococcus spp. from cultured isolates 
derived from clinical specimens. The identification aids in the 
diagnosis of diseases caused by bacteria belonging to the genus 
Streptococcus and provides epidemiological information on these 
diseases. Pathogenic streptococci are associated with infections, such 
as sore throat, impetigo (an infection characterized by small pustules 
on the skin), urinary tract infections, rheumatic fever, and kidney 
disease.
    (b) Classification. Class I (general controls). The device is exempt 
from the premarket notification procedures in subpart E of part 807 of 
this chapter subject to Sec. 866.9.

[47 FR 50823, Nov. 9, 1982, as amended at 65 FR 2312, Jan. 14, 2000]



Sec. 866.3780  Toxoplasma gondii serological reagents.

    (a) Identification. Toxoplasma gondii serological reagents are 
devices that consist of antigens and antisera used in serological tests 
to identify antibodies to Toxoplasma gondii in serum. Additionally, some 
of these reagents consist of antisera conjugated with a fluorescent dye 
(immunofluorescent reagents) used to identify Toxoplasma gondii from 
clinical specimens. The identification aids in the diagnosis of 
toxoplasmosis caused by the parasitic protozoan Toxoplasma gondii and 
provides epidemiological information on this disease. Congenital 
toxoplasmosis is characterized by lesions of the central nervous system, 
which if undetected and untreated may lead to brain defects, blindness, 
and death of an unborn fetus. The disease is characterized in children 
by inflammation of the brain and spinal cord.
    (b) Classification. Class II (performance standards).



Sec. 866.3820  Treponema pallidum nontreponemal test reagents.

    (a) Identification. Treponema pallidum nontreponemal test reagents 
are devices that consist of antigens derived from nontreponemal sources 
(sources not directly associated with treponemal organisms) and control 
sera (standardized sera with which test results are compared) used in 
serological tests to identify reagin, an antibody-like agent, which is 
produced from the reaction of treponema microorganisms with body 
tissues. The identification aids in the diagnosis of syphilis caused by 
microorganisms belonging to the genus Treponema and provides 
epidemiological information on syphilis.
    (b) Classification. Class II (performance standards).



Sec. 866.3830  Treponema pallidum treponemal test reagents.

    (a) Identification. Treponema pallidum treponemal test reagents are 
devices that consist of the antigens, antisera and all control reagents 
(standardized reagents with which test results are compared) which are 
derived from treponemal sources and that are used in the fluorescent 
treponemal antibody absorption test (FTA-ABS), the Treponema pallidum 
immobilization test (T.P.I.), and other treponemal tests used to 
identify antibodies to Treponema pallidum directly from infecting 
treponemal organisms in serum. The identification aids in the diagnosis 
of syphilis caused by bacteria belonging to the genus Treponema and 
provides epidemiological information on syphilis.
    (b) Classification. Class II (performance standards).



Sec. 866.3850  Trichinella spiralis serological reagents.

    (a) Identification. Trichinella spiralis serological reagents are 
devices that consist of antigens and antisera used in serological tests 
to identify antibodies to Trichinella spiralis in serum. The

[[Page 253]]

identification aids in the diagnosis of trichinosis caused by parasitic 
roundworms belonging to the genus Trichinella and provides 
epidemiological information on trichinosis. Trichinosis is caused by 
ingestion of undercooked, infested meat, especially pork, and 
characterized by fever, muscle weakness, and diarrhea.
    (b) Classification. Class I (general controls). The device is exempt 
from the premarket notification procedures in subpart E of part 807 of 
this chapter subject to Sec. 866.9.

[47 FR 50823, Nov. 9, 1982, as amended at 65 FR 2312, Jan. 14, 2000]



Sec. 866.3870  Trypanosoma spp. serological reagents.

    (a) Identification. Trypanosoma spp. serological reagents are 
devices that consist of antigens and antisera used in serological tests 
to identify antibodies to Trypanosoma spp. in serum. The identification 
aids in the diagnosis of trypanosomiasis, a disease caused by parasitic 
protozoans belonging to the genus Trypanosoma. Trypanosomiasis in adults 
is a chronic disease characterized by fever, chills, headache, and 
vomiting. Central nervous system involvement produces typical sleeping 
sickness syndrome: physical exhaustion, inability to eat, tissue 
wasting, and eventual death. Chagas disease, an acute form of 
trypanosomiasis in children, most seriously affects the central nervous 
system and heart muscle.
    (b) Classification. Class I (general controls).



Sec. 866.3900  Varicella-zoster virus serological reagents.

    (a) Identification. Varicella-zoster virus serological reagents are 
devices that consist of antigens and antisera used in serological tests 
to identify antibodies to varicella-zoster in serum. The identification 
aids in the diagnosis of diseases caused by varicella-zoster viruses and 
provides epidemiological information on these diseases. Varicella 
(chicken pox) is a mild, highly infectious disease, chiefly of children. 
Zoster (shingles) is the recurrent form of the disease, occurring in 
adults who were previously infected with varicella-zoster viruses. 
Zoster is the response (characterized by a rash) of the partially immune 
host to a reactivation of varicella viruses present in latent form in 
the patient's body.
    (b) Classification. Class II (performance standards).



Sec. 866.3930  Vibrio cholerae serological reagents.

    (a) Identification. Vibrio cholerae serological reagents are devices 
that are used in the agglutination (an antigen-antibody clumping 
reaction) test to identify Vibrio cholerae from cultured isolates 
derived from clinical specimens. The identification aids in the 
diagnosis of cholera caused by the bacterium Vibrio cholerae and 
provides epidemiological information on cholera. Cholera is an acute 
infectious disease characterized by severe diarrhea with extreme fluid 
and electrolyte (salts) depletion, and by vomiting, muscle cramps, and 
prostration. If untreated, the severe dehydration may lead to shock, 
renal failure, cardiovascular collapse, and death.
    (b) Classification. Class II (special controls). The device is 
exempt from the premarket notification procedures in subpart E of part 
807 of this chapter subject to Sec. 866.9.

[47 FR 50823, Nov. 9, 1982, as amended at 63 FR 59227, Nov. 3, 1998]



         Subpart E--Immunology Laboratory Equipment and Reagents



Sec. 866.4100  Complement reagent.

    (a) Identification. A complement reagent is a device that consists 
of complement, a naturally occurring serum protein from any warm-blooded 
animal such as guinea pigs, that may be included as a component part of 
serological test kits used in the diagnosis of disease.
    (b) Classification. Class I (general controls). The device is exempt 
from the premarket notification procedures in subpart E of part 807.



Sec. 866.4500  Immunoelectrophoresis equipment.

    (a) Identification. Immunoelectrophoresis equipment for clinical use 
with its electrical power supply is a device used for separating protein 
molecules. Immunoelectrophoresis is a

[[Page 254]]

procedure in which a complex protein mixture is placed in an agar gel 
and the various proteins are separated on the basis of their relative 
mobilities under the influence of an electric current. The separated 
proteins are then permitted to diffuse through the agar toward a 
multispecific antiserum, allowing precipitation and visualization of the 
separate complexes.
    (b) Classification. Class I. The device is exempt from the premarket 
notification procedures in subpart E of part 807 of this chapter.

[47 FR 50823, Nov. 9, 1982, as amended at 54 FR 25047, June 12, 1989]



Sec. 866.4520  Immunofluorometer equipment.

    (a) Identification. Immunofluorometer equipment for clinical use 
with its electrical power supply is a device used to measure the 
fluorescence of fluorochrome-labeled antigen-antibody complexes. The 
concentration of these complexes may be measured by means of reflected 
light. A beam of light is passed through a solution in which a 
fluorochrome has been selectively attached to serum protein antibody 
molecules in suspension. The amount of light emitted by the fluorochrome 
label is detected by a photodetector, which converts light energy into 
electrical energy. The amount of electrical energy registers on a 
readout system such as a digital voltmeter or a recording chart. This 
electrical readout is called the fluorescence value and is used to 
measure the concentration of antigen-antibody complexes.
    (b) Classification. Class I. The device is exempt from the premarket 
notification procedures in subpart E of part 807 of this chapter.

[47 FR 50823, Nov. 9, 1982, as amended at 54 FR 25047, June 12, 1989]



Sec. 866.4540  Immunonephelometer equipment.

    (a) Identification. Immunonephelometer equipment for clinical use 
with its electrical power supply is a device that measures light 
scattering from antigen-antibody complexes. The concentration of these 
complexes may be measured by means of reflected light. A beam of light 
passed through a solution is scattered by the particles in suspension. 
The amount of light is detected by a photodetector, which converts light 
energy into electrical energy. The amount of electrical energy registers 
on a readout system such as a digital voltmeter or a recording chart. 
This electrical readout is called the light-scattering value and is used 
to measure the concentration of antigen-antibody complexes. This generic 
type of device includes devices with various kinds of light sources, 
such as laser equipment.
    (b) Classification. Class I. The device is exempt from the premarket 
notification procedures in subpart E of part 807 of this chapter.

[47 FR 50823, Nov. 9, 1982, as amended at 54 FR 25047, June 12, 1989]



Sec. 866.4600  Ouchterlony agar plate.

    (a) Identification. An ouchterlony agar plate for clinical use is a 
device containing an agar gel used to examine antigen-antibody 
reactions. In immunodiffusion, antibodies and antigens migrate toward 
each other through gel which originally contained neither of these 
reagents. As the reagents come in contact with each other, they combine 
to form a precipitate that is trapped in the gel matrix and is 
immobilized.
    (b) Classification. Class I. The device is exempt from the premarket 
notification procedures in subpart E of part 807 of this chapter.

[47 FR 50823, Nov. 9, 1982, as amended at 54 FR 25047, June 12, 1989]



Sec. 866.4800  Radial immunodiffusion plate.

    (a) Identification. A radial immunodiffusion plate for clinical use 
is a device that consists of a plastic plate to which agar gel 
containing antiserum is added. In radial immunodiffusion, antigens 
migrate through gel which originally contains specific antibodies. As 
the reagents come in contact with each other, they combine to form a 
precipitate that is trapped in the gel matrix and immobilized.
    (b) Classification. Class I (general controls). The device is exempt 
from the premarket notification procedures in subpart E of part 807.

[[Page 255]]



Sec. 866.4830  Rocket immunoelectrophoresis equipment.

    (a) Identification. Rocket immunoelectrophoresis equipment for 
clinical use is a device used to perform a specific test on proteins by 
using a procedure called rocket immunoelectrophoresis. In this 
procedure, an electric current causes the protein in solution to migrate 
through agar gel containing specific antisera. The protein precipitates 
with the antisera in a rocket-shaped pattern, giving the name to the 
device. The height of the peak (or the area under the peak) is 
proportional to the concentration of the protein.
    (b) Classification. Class I. The device is exempt from the premarket 
notification procedures in subpart E of part 807 of this chapter.

[47 FR 50823, Nov. 9, 1982, as amended at 54 FR 25047, June 12, 1989]



Sec. 866.4900  Support gel.

    (a) Identification. A support gel for clinical use is a device that 
consists of an agar or agarose preparation that is used while measuring 
various kinds of, or parts of, protein molecules by various 
immunochemical techniques, such as immunoelectrophoresis, 
immunodiffusion, or chromatography.
    (b) Classification. Class I. The device is exempt from the premarket 
notification procedures in subpart E of part 807 of this chapter.

[47 FR 50823, Nov. 9, 1982, as amended at 54 FR 25047, June 12, 1989]



                  Subpart F--Immunological Test Systems



Sec. 866.5040  Albumin immunological test system.

    (a) Identification. An albumin immunological test system is a device 
that consists of the reagents used to measure by immunochemical 
techniques the albumin (a plasma protein) in serum and other body 
fluids. Measurement of albumin aids in the diagnosis of kidney and 
intestinal diseases.
    (b) Classification. Class II (special controls). The device is 
exempt from the premarket notification procedures in subpart E of part 
807 of this chapter subject to Sec. 866.9.

[47 FR 50823, Nov. 9, 1982, as amended at 63 FR 59227, Nov. 3, 1998]



Sec. 866.5060  Prealbumin immunological test system.

    (a) Identification. A prealbumin immunological test system is a 
device that consists of the reagents used to measure by immunochemical 
techniques the prealbumin (a plasma protein) in serum and other body 
fluids. Measurement of prealbumin levels in serum may aid in the 
assessment of the patient's nutritional status.
    (b) Classification. Class I (general controls). The device is exempt 
from the premarket notification procedures in subpart E of part 807 of 
this chapter subject to Sec. 866.9.

[47 FR 50823, Nov. 9, 1982, as amended at 65 FR 2312, Jan. 14, 2000]



Sec. 866.5065  Human allotypic marker immunological test system.

    (a) Identification. A human allotypic marker immunological test 
system is a device that consists of the reagents used to identify by 
immunochemical techniques the inherited human protein allotypic markers 
(such as nGm, nA2 m, and Km allotypes) in serum and other 
body fluids. The identification may be used while studying population 
genetics.
    (b) Classification. Class I (general controls). The device is exempt 
from the premarket notification procedures in subpart E of part 807 of 
this chapter subject to Sec. 866.9.

[47 FR 50823, Nov. 9, 1982, as amended at 65 FR 2312, Jan. 14, 2000]



Sec. 866.5080  Alpha-1-antichymotrypsin immunological test system.

    (a) Identification. An alpha-1-antichymotrypsin immunological test 
system is a device that consists of the reagents used to measure by 
immunochemical techniques alpha-1-antichymotrypsin (a protein) in serum, 
other body fluids, and tissues. Alpha-1-antichymotrypsin helps protect 
tissues against proteolytic (protein-splitting) enzymes released during 
infection.
    (b) Classification. Class II (performance standards).

[[Page 256]]



Sec. 866.5090  Antimitochondrial antibody immunological test system.

    (a) Identification. An antimitochondrial antibody immunological test 
system is a device that consists of the reagents used to measure by 
immunochemical techniques the antimitochondrial antibodies in human 
serum. The measurements aid in the diagnosis of diseases that produce a 
spectrum of autoantibodies (antibodies produced against the body's own 
tissue), such as primary biliary cirrhosis (degeneration of liver 
tissue) and chronic active hepatitis (inflammation of the liver).
    (b) Classification. Class II (performance standards).



Sec. 866.5100  Antinuclear antibody immunological test system.

    (a) Identification. An antinuclear antibody immunological test 
system is a device that consists of the reagents used to measure by 
immunochemical techniques the autoimmune antibodies in serum, other body 
fluids, and tissues that react with cellular nuclear constituents 
(molecules present in the nucleus of a cell, such as ribonucleic acid, 
deoxyribonucleic acid, or nuclear proteins). The measurements aid in the 
diagnosis of systemic lupus erythematosus (a multisystem autoimmune 
disease in which antibodies attack the victim's own tissues), hepatitis 
(a liver disease), rheumatoid arthritis, Sjogren's syndrome (arthritis 
with inflammation of the eye, eyelid, and salivary glands), and systemic 
sclerosis (chronic hardening and shrinking of many body tissues).
    (b) Classification. Class II (performance standards).



Sec. 866.5110  Antiparietal antibody immunological test system.

    (a) Identification. An antiparietal antibody immunological test 
system is a device that consists of the reagents used to measure by 
immunochemical techniques the specific antibody for gastric parietal 
cells in serum and other body fluids. Gastric parietal cells are those 
cells located in the stomach that produce a protein that enables vitamin 
B12 to be absorbed by the body. The measurements aid in the 
diagnosis of vitamin B12 deficiency (or pernicious anemia), 
atrophic gastritis (inflammation of the stomach), and autoimmune 
connective tissue diseases (diseases resulting when the body produces 
antibodies against its own tissues).
    (b) Classification. Class II (performance standards).



Sec. 866.5120  Antismooth muscle antibody immunological test system.

    (a) Identification. An antismooth muscle antibody immunological test 
system is a device that consists of the reagents used to measure by 
immunochemical techniques the antismooth muscle antibodies (antibodies 
to nonstriated, involuntary muscle) in serum. The measurements aid in 
the diagnosis of chronic hepatitis (inflammation of the liver) and 
autoimmune connective tissue diseases (diseases resulting from 
antibodies produced against the body's own tissues).
    (b) Classification Class II (performance standards).



Sec. 866.5130  Alpha-1-antitrypsin immunological test system.

    (a) Identification. An alpha-1-antitrypsin immunological test system 
is a device that consists of the reagents used to measure by 
immunochemical techniques the alpha-1-antitrypsin (a plasma protein) in 
serum, other body fluids, and tissues. The measurements aid in the 
diagnosis of several conditions including juvenile and adult cirrhosis 
of the liver. In addition, alpha-1-antitrypsin deficiency has been 
associated with pulmonary emphysema.
    (b) Classification. Class II (performance standards).



Sec. 866.5150  Bence-Jones proteins immunological test system.

    (a) Identification. A Bence-Jones proteins immunological test system 
is a device that consists of the reagents used to measure by 
immunochemical techniques the Bence-Jones proteins in urine and plasma. 
Immunoglobulin molecules normally consist of pairs of polypeptide chains 
(subunits) of unequal size (light chains and heavy chains) bound 
together by several disulfide bridges. In some cancerous conditions, 
there is a proliferation of one plasma cell (antibody-producing cell) 
with excess production of light chains

[[Page 257]]

of one specific kind (monoclonal light chains). These free homogeneous 
light chains not associated with an immunoglobulin molecule can be found 
in urine and plasma, and have been called Bence-Jones proteins. 
Measurement of Bence-Jones proteins and determination that they are 
monoclonal aid in the diagnosis of multiple myeloma (malignant 
proliferation of plasma cells), Waldenstrom's macroglobulinemia 
(increased production of large immunoglobulins by spleen and bone marrow 
cells), leukemia (cancer of the blood-forming organs), and lymphoma 
(cancer of the lymphoid tissue).
    (b) Classification. Class II (performance standards).



Sec. 866.5160  Beta-globulin immunological test system.

    (a) Identification. A beta-globulin immunological test system is a 
device that consists of reagents used to measure by immunochemical 
techniques beta globulins (serum protein) in serum and other body 
fluids. Beta-globulin proteins include beta-lipoprotein, transferrin, 
glycoproteins, and complement, and are rarely associated with specific 
pathologic disorders.
    (b) Classification. Class I (general controls). The device is exempt 
from the premarket notification procedures in subpart E of part 807 of 
this chapter subject to Sec. 866.9.

[47 FR 50823, Nov. 9, 1982, as amended at 65 FR 2312, Jan. 14, 2000]



Sec. 866.5170  Breast milk immunological test system.

    (a) Identification. A breast milk immunological test system is a 
device that consists of the reagents used to measure by immunochemical 
techniques the breast milk proteins.
    (b) Classification. Class I. The device is exempt from the premarket 
notification procedures in subpart E of part 807 of this chapter.

[47 FR 50823, Nov. 9, 1982, as amended at 59 FR 63007, Dec. 7, 1994]



Sec. 866.5200  Carbonic anhydrase B and C immunological test system.

    (a) Identification. A carbonic anhydrase B and C immunological test 
system is a device that consists of the reagents used to measure by 
immunochemical techniques specific carbonic anhydrase protein molecules 
in serum and other body fluids. Measurements of carbonic anhydrase B and 
C aid in the diagnosis of abnormal hemoglobin metabolism.
    (b) Classification. Class I (general controls). The device is exempt 
from the premarket notification procedures in subpart E of part 807 of 
this chapter subject to Sec. 866.9.

[47 FR 50823, Nov. 9, 1982, as amended at 65 FR 2312, Jan. 14, 2000]



Sec. 866.5210  Ceruloplasmin immunological test system.

    (a) Identification. A ceruloplasmin immunological tes