[Federal Register Volume 65, Number 10 (Friday, January 14, 2000)]
[Rules and Regulations]
[Pages 2296-2323]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 00-884]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Parts 862, 864, 866, 868, 870, 872, 874, 876, 878, 880, 882, 
884, 886, 888, 890, and 892

[Docket No. 98N-0009]


Medical Devices; Exemption From Premarket Notification and 
Reserved Devices; Class I

AGENCY: Food and Drug Administration, HHS.

ACTION: Final rule.

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SUMMARY: The Food and Drug Administration (FDA) is amending its 
classification regulations to designate class I devices that are exempt 
from the premarket notification requirements, subject to certain 
limitations, and to designate those class I devices that remain subject 
to premarket notification requirements under the new statutory criteria 
for premarket notification requirements. The devices FDA is designating 
as exempt do not include class I devices that have been previously 
exempted by regulation from the premarket notification requirements. 
This action is being taken under the Federal Food, Drug, and Cosmetic 
Act (the act), as amended by the Medical Device Amendments of 1976 (the 
1976 amendments), the Safe Medical Devices Act of 1990 (SMDA), and the 
FDA Modernization Act of 1997 (FDAMA). FDA is taking this action in 
order to implement a requirement of FDAMA. Elsewhere in this issue of 
the Federal Register, FDA is announcing that it is withdrawing proposed 
rules to revoke existing exemptions from premarket notification for two 
devices.

DATES: This regulation is effective February 14, 2000.

FOR FURTHER INFORMATION CONTACT: Heather S. Rosecrans, Center for 
Devices and Radiological Health (HFZ-404), Food and Drug 
Administration, 9200 Corporate Blvd., Rockville, MD 20850, 301-594-
1190.

SUPPLEMENTARY INFORMATION:

I. Statutory Background

    Under section 513 of the act (21 U.S.C. 360c), FDA must classify 
devices into one of three regulatory classes: Class I, class II, or 
class III. FDA classification of a device is determined by the amount 
of regulation necessary to provide a reasonable assurance of safety and 
effectiveness. Under the 1976 amendments (Public Law 94-295), as 
amended by the SMDA (Public Law 101-629), devices are to be classified 
into class I (general controls) if there is information showing that 
the general controls of the act are sufficient to ensure safety and 
effectiveness; into class II (special controls), if general controls, 
by themselves, are insufficient to provide reasonable assurance of 
safety and effectiveness, but there is sufficient information to 
establish special controls to provide such assurance; and into class 
III (premarket approval), if there is insufficient information to 
support classifying a device into class I or class II and the device is 
a life-sustaining or life-supporting device, or is for a use which is 
of substantial importance in preventing impairment of human health, or 
presents a potential unreasonable risk of illness or injury.
    Most generic types of devices that were on the market before the 
date of the 1976 amendments (May 28, 1976) (generally referred to as 
preamendments devices) have been classified by FDA under the procedures 
set forth in section 513(c) and (d) of the act through the issuance of 
classification regulations into one of these three regulatory classes. 
Devices introduced into interstate commerce for the first time on or 
after May 28, 1976 (generally referred to as postamendments devices) 
are classified through the premarket notification process under section 
510(k) of the act (21 U.S.C. 360(k)). Section 510(k) of the act and the 
implementing regulations, part 807 (21 CFR part 807), require persons 
who intend to market a new device to submit a premarket notification 
report (510(k)) containing information that allows FDA to determine 
whether the new device is substantially equivalent within the meaning 
of section 513(i) of the act to a legally marketed device that does not 
require premarket approval. Unless exempted from premarket notification 
requirements, persons may not market a new device under section 510(k) 
of the act, unless they receive a substantial equivalence order from 
FDA or an order reclassifying the device into class I or class II, 
under section 513(f) of the act.
    On November 21, 1997, the President signed FDAMA into law (Public 
Law 105-115). Section 206 of FDAMA, in part, added a new section 510(l) 
to the act. Under section 206 of FDAMA, new section 510(l) of the act 
became effective on February 19, 1998. New section 510(l) of the act 
provides that a class I device is exempt from the premarket 
notification requirements under section 510(k) of the act, unless the 
device is intended for a use which is of substantial importance in 
preventing impairment of human health or it presents a potential 
unreasonable risk of illness or injury. This document refers to devices 
that FDA believes meet these criteria as ``reserved.'' FDA has 
evaluated all class I devices to determine which device types should be 
subject to premarket notification requirements.
    In developing the list of reserved devices, the agency considered 
its experience in reviewing premarket notifications for these device 
types, focusing on the risk inherent with the device and/or the disease 
being treated or diagnosed. FDA believes that the devices listed as 
reserved are intended for a use that is of substantial importance in 
preventing impairment of human health or present a potential 
unreasonable risk of illness or injury.

II. Limitations on Exemptions

    FDA believes that the generic types of class I devices listed 
herein, in addition to a vast majority of class I devices previously 
exempted, should be exempt from the premarket notification requirements 
under section 510(l) of the act. FDA further believes, however, that 
these generic device categories should be exempt only to the extent 
that they have existing or reasonably foreseeable characteristics of 
commercially distributed devices within that generic type or, in the 
case of in vitro diagnostic devices (IVD's), only to the extent that 
misdiagnosis as a result of using the device would not be associated 
with high morbidity or mortality. FDA believes that certain changes to 
devices within a generic device type that is generally exempt may make 
the device intended for a use that is of substantial importance in 
preventing impairment of human health or may make the device present a 
potential unreasonable risk of illness or injury. Accordingly, devices 
changed in this manner would fall within the reserved criteria under 
section 510(l) of the act and would require premarket notification.
    FDA believes that devices that have different intended uses than 
legally marketed devices in that generic device type present a 
potential unreasonable risk of illness or injury because their safety 
and effectiveness characteristics

[[Page 2297]]

are unknown. Moreover, FDA believes that IVD's are intended for a use 
that is of substantial importance in preventing impairment of human 
health or present a potential unreasonable risk of illness or injury, 
if misdiagnosis, as a result of using the device, could result in high 
morbidity or mortality.
    Accordingly, because FDA believes that devices incorporating the 
characteristics described above fit within the reserved criteria under 
section 510(l) of the act, FDA considers any class I device to be 
subject to premarket notification requirements if the device: (1) Has 
an intended use that is 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 instead of use by health care professionals); or (2) operates 
using a different fundamental scientific technology than that used by 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 IVD detects or identifies infectious 
agents by using a deoxyribonucleic acid (DNA) probe or nucleic acid 
hybridization or amplification technology rather than culture or 
immunoassay technology); or (3) is an in vitro device that is intended: 
(a) For use in the diagnosis, monitoring, or screening of neoplastic 
diseases with the exception of immunohistochemical devices; (b) for use 
in screening or diagnosis of familial and acquired genetic disorders, 
including inborn errors of metabolism; (c) 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; (d) to assess the risk of 
cardiovascular diseases; (e) for use in diabetes management; (f) to 
identify or infer the identity of a microorganism directly from 
clinical material; (g) for detection of antibodies to microorganisms 
other than immunoglobulin G (IgG) and 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; (h) for 
noninvasive testing as defined in Sec. 812.3(k) (21 CFR 812.3(k)); and 
(9) for near patient testing (point of care). FDA is revising 
Secs. 862.9, 864.9, and 866.9 (21 CFR 862.9, 864.9, and 866.9) to 
incorporate these revised limitations on exemptions for IVD's. FDA 
believes that these limitations, for the reasons described previously, 
are appropriate for IVD's.
    FDA is also amending all current limitations on exemptions sections 
(21 CFR 862.9, 864.9, 866.9, 868.9, 870.9, 872.9, 874.9, 876.9, 878.9, 
880.9, 882.9, 884.9, 886.9, 888.9, 890.9, and 892.9) in two ways. 
First, the limitations language clarifies that these limitations apply 
to class II, as well as class I devices. On January 21, 1998 (63 FR 
3142), FDA published a list of exempted class II devices, subject to 
certain limitations. Under section 510(m)(1) of the act, as added by 
FDAMA, FDA was provided the authority to exempt these class II devices 
from premarket notification upon issuance of a notice. FDA codified 
these exemptions, including the limitations described in the January 
21, 1998, Federal Register notice, by issuance of a final rule on 
November 3, 1998 (63 FR 59222).
    The limitations language in this document for class I devices is 
identical to those limitations for class II devices that became 
effective on January 21, 1998. Accordingly, the limitations sections 
state that the scope of these limitations apply to class II, as well as 
class I devices.
    Second, FDA is amending the limitations language to state that 
premarket notifications must be submitted for class I exempt devices if 
the intended use is different than the ``legally marketed devices in 
that generic type.'' Currently, the limitations in each classification 
regulation (e.g., Secs. 862.9, 864.9, etc.) state that manufacturers 
must submit premarket notifications for class I exempt devices when 
``[t]he device is intended for a use different from its intended use 
before May 28, 1976, or the device is intended for a use different from 
the intended use of a preamendments device to which it had been 
determined to be substantially equivalent;''. Devices that have an 
intended use that differs from any legally marketed device are not 
exempt because those devices present a potential unreasonable risk of 
illness or injury because their safety and effectiveness 
characteristics are unknown. Manufacturers of such devices must submit 
a premarket notification and the agency will determine if they are 
substantially equivalent to other legally marketed devices in that 
generic device type.
    In addition to the general limitations on exemptions applicable to 
all class I devices that are described previously, certain devices 
within a generic class also remain subject to the premarket 
notification requirements because they either are intended for a use 
that is of substantial importance in preventing impairment of human 
health or they present a potential unreasonable risk of illness or 
injury. For example, elsewhere in this document, FDA states that liquid 
bandages are generally exempt from the premarket notification 
requirements, but a subcategory of those devices, those intended for 
treatment of burns and other open wounds, remains subject to the 
premarket notification requirements. FDA believes that liquid bandages 
intended for burns and other open wounds should remain subject to this 
requirement because they are of substantial importance in preventing 
impairment of human health by helping to prevent infections.
    FDA also advises that an exemption from the requirement of 
premarket notification does not mean that the device is exempt from any 
other statutory or regulatory requirements, unless such exemption is 
explicitly provided by order or regulation.
    The limitations in each classification regulation apply to the 
premarket notification exemptions for each generic device classified in 
each section. In addition to mentioning the limitations generally in 
each classification regulation, FDA specifically states in the 
classification sections for each generic device that is newly exempted 
under section 510(l) of the act that the exemptions are subject to 
limitations. For example, with this regulation Sec. 862.1200 states 
that the corticosterone test system ``is exempt from the premarket 
notification procedures in subpart E of part 807 of this chapter 
subject to Sec. 862.9.'' (Emphasis added.) FDA is adding this language 
specifically referring to the limitations language for clarity and 
convenience.
    Individual device classification sections that have been codified 
previously that are exempt from premarket notification requirements, 
subject to limitations, do not specifically refer to the general 
limitations section. For these classifications, FDA intends to codify 
language in the near future that will mention the limitations sections 
in each device classification.

III. Analysis of Comments

    In the Federal Register of February 2, 1998 (63 FR 5387), FDA 
published a list of devices it considered reserved and that require 
premarket notification and a list of devices it believed met the 
exemption criteria in FDAMA. FDA invited comments on the February 2, 
1998, notice.
    In the Federal Register of November 12, 1998 (63 FR 63222), after 
reviewing the comments submitted on the February 2, 1998, Federal 
Register

[[Page 2298]]

notice, FDA proposed to designate which devices require premarket 
notification, and which are exempt, subject to limitations, under 
notice and comment rulemaking proceedings under new section 510(l) of 
the act. FDA received four comments in response to the proposed rule. 
The following is FDA's response to those comments.
    1. One comment in regard to unscented menstrual pads 
(Sec. 884.5435) (21 CFR 884.5435)) stated that: (1) Interlabial pads do 
not contact vaginal tissue; (2) interlabial pads should not be grouped 
with reusable menstrual pads in the regulation because they have 
different risks; and (3) the term ``intralabial'' is not accurate and 
the correct nomenclature is ``interlabial.''
    Both interlabial pads and reusable pads are types of unscented 
menstrual pads that meet the reserved criteria, and, therefore, must 
meet the premarket notification requirements. Other types of unscented 
menstrual pads are exempt. Although FDA agrees that interlabial pads do 
not contact vaginal tissue and that interlabial pads present different 
risks than reusable menstrual pads, both types of pads still meet the 
reserved criteria. FDA did not group these types of pads as reserved 
devices because they had the same risks but has determined both need to 
undergo premarket review based on their risks independently. FDA agrees 
that the term the term ``interlabial'' is more appropriate than the 
term ``intralabial'' and is using the term ``interlabial'' in the final 
rule and Sec. 884.5435.
    2. Another comment requested clarification of the scope of the 
classification and exemption of the blood bank centrifuge for in vitro 
diagnostic use (Sec. 864.9275 (21 CFR 864.9275)). More specifically, 
the comment asked whether centrifuges used to separate whole blood into 
its component parts for eventual transfusion to patients are exempt 
from premarket notification.
    Section 864.9275 applies to the small tabletop centrifuges used to 
spin down test tubes of blood samples used in immunohematology tests. 
This classification does not include a centrifuge used to separate or 
prepare blood components for transfusion, which is classified in class 
II as an autotransfusion apparatus (21 CFR 868.5830) and is subject to 
premarket notification requirements.
    3. One comment requested clarification about how the ``Limitations 
to exemption'' apply to a device labeled for general use, such as 21 
CFR 862.2300 Colorimeter, photometer, or spectrophotometer for clinical 
use or 21 CFR 862.2560 Fluorometer for clinical use. Section 862.9(c) 
states the exemption from 510(k) of the act does not apply if the 
device is intended, ``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.''
    The ``Limitations to exemption'' refer to the device, as labeled. 
If the device has been labeled as a general purpose device, and was 
exempt, and it is now to be labeled for a specific indication, such as 
cytomegalovirus, a new 510(k) must be submitted and cleared before that 
specific indication can be marketed.
    4. One comment regarding the ``Limitations to exemption'' objected 
to the revocation of the premarket notification exemption for the 
cardiopulmonary bypass accessory equipment involving an electrical 
connection to the patient prior to up-classifying them into class II in 
order to comply with the performance standard for cables and leads. The 
comment stated that many of the cardiopulmonary bypass devices did not 
involve a cable or lead.
    FDA has reviewed the devices that fall under this regulation and 
agrees that many of the devices do not involve electrical connections 
to the patient. On August 9, 1999 (64 FR 43114), FDA published a 
proposed rule to reclassify three devices into class II in order to 
make them subject to the performance standard for electrode lead wires 
and patient cables. These three devices are: (1) Cardiopulmonary bypass 
accessory equipment that involves an electrical connection to the 
patient, (2) the goniometer device, and (3) the electrode cable. Under 
this proposal, cardiopulmonary bypass accessory equipment that does not 
involve an electrical connection to the patient would remain in class I 
and would be exempt from the premarket notification requirements. 
Because FDA believes that compliance with the performance standard for 
electrode lead wires and patient cables would provide adequate 
assurance of the safety and effectiveness of these devices, the 
proposal provides that these devices would be exempt from the premarket 
notification requirements.
    Elsewhere in this issue of the Federal Register, FDA is announcing 
that it is withdrawing the proposed rules to revoke the exemptions from 
premarket notification for cardiopulmonary bypass accessory equipment 
and the electrode cable. Under existing 21 CFR 870.4200 
(cardiopulmonary bypass accessory equipment) and 21 CFR 890.1175 
(electrode cable), these devices are exempt from the premarket 
notification requirements. These exemptions will remain in effect. FDA 
expects to finalize the August 9, 1999, proposed rule to make these 
devices class II shortly after the comment period ends on November 8, 
1999. If the rule is finalized, the devices will be exempt from the 
premarket notification requirements and all such devices will be 
subject to the performance standard for electrode lead wires and 
patient cables, when the second phase of that rule becomes effective on 
May 9, 2000. FDA believes that there is no reason to make these devices 
subject to premarket notification requirements for the short period of 
time between the revocation of the exemption from premarket 
notification requirements, as proposed in the November 12, 1998, 
Federal Register, and the reclassification and exemption from premarket 
notification requirements of these devices, as proposed in the August 
9, 1999, Federal Register.
    The goniometer device is not a subject of this rule and premarket 
notification is still required for these devices under existing 21 CFR 
888.1500, until the August 9, 1999, rule is finalized.
    5. FDA, on its own initiative, is adding all versions of the 
keratoscope (21 CFR 886.1350) to the list of devices exempt from 
premarket notification requirements. Previously, only keratoscopes that 
did not include computer software were exempt from premarket 
notification. In the Federal Register of February 2, 1998 (63 FR 5387), 
FDA listed a keratoscope with computer software, as a device that it 
believed fell under the exemption criteria in section 510(l) of the 
act. The proposed rule, however, did not include the keratoscope with 
computer software under those devices FDA proposed to codify as exempt. 
Subsequent to the issuance of the proposed rule, FDA received an 
inquiry concerning the exemption status of this device. Upon 
consideration, FDA does not believe that the keratoscope with computer 
software is intended for a use that is of substantial importance in 
preventing impairment of human health or that it presents a potential 
unreasonable risk of illness or injury and therefore it is exempt from 
the premarket notification requirements.
    6. FDA, on its own initiative, has made some minor changes in the 
sections of each classification, which describe the limitations to 
exemptions from section 510(k) of the act. In these sections, FDA lists 
certain intended uses or changes that will preclude a device

[[Page 2299]]

from falling within an exemption that is otherwise applicable to a 
generic class of devices.
    In the final rule, FDA made some nonsubstantive changes in the 
introductory paragraph that clarify FDA's reasons for the types of 
limitations listed. In proposed sections of each classification 
regulation, FDA explained that it listed the limitations because those 
types of changes were unforeseeable, and, therefore could significantly 
affect safety and effectiveness. The final rule clarifies that FDA also 
listed certain types of limitations because any misdiagnosis using 
devices for the listed intended uses may be associated with high 
morbidity or mortality.
    In addition, FDA has made minor changes in describing two of the 
intended uses of in vitro devices that would require a premarket 
notification. Proposed limitations in paragraph (c)(2) stated that 
premarket notifications must be submitted when a device is an in vitro 
device that is intended for use in ``screening or diagnosis of familial 
and acquired genetic disorders, including inborn errors of 
metabolism.'' (Emphasis added.) The proposed rule may have been 
interpreted to require premarket notification for only devices that 
were used in screening or diagnosis of both familial and acquired 
genetic disorders.
    FDA intended that devices used in connection with either familial 
or acquired genetic disorders be subject to premarket notification 
requirements because misdiagnosis of either of these disorders would be 
associated with high morbidity or mortality. Accordingly, FDA has 
amended the final rule in each limitation section of each 
classification regulation to state that premarket notifications must be 
submitted when a device is an in vitro device that is intended for use 
in ``screening or diagnosis of familial or acquired genetic disorders, 
including inborn errors of metabolism.'' (Emphasis added.)
    Similarly, FDA stated in the proposed limitation in paragraph 
(c)(7) that it would require premarket notification for in vitro 
devices intended for detection of antibodies to microorganisms other 
than immunoglobulin G (IgG) and IgG assays when the results are not 
qualitative * * *.'' The proposed rule could be interpreted to require 
premarket notification unless the device were intended for detection of 
both IgG and IgG assays. FDA is amending the final rule in the 
limitation in paragraph (c)(7) by replacing the word ``and'' with 
``or'' to indicate that if an exempt in vitro device is intended to 
detect antibodies to either IgG or IgG assays, the device will remain 
exempt.
    7. FDA, on its own initiative, has added language clarifying the 
description of exempted devices in Sec. 880.5090 Liquid bandage (21 CFR 
880.5090), Sec. 886.4070 Powered corneal burr (21 CFR 886.4070), and 
Sec. 886.4750 Ophthalmic eye shield (21 CFR 886.4750). The proposed 
classification descriptions state that the devices were exempt from 
premarket notification requirements when used for certain intended 
uses. FDA has added language to clarify that the exemption applies only 
when the device is used exclusively for the intended uses stated in the 
classification descriptions.
    For example, proposed Sec. 880.5090 Liquid bandage stated: ``When 
used as a skin protectant, the device is exempt from premarket 
notification procedures.'' FDA amended final Sec. 880.5090 by adding 
the word ``only'' to the text to clarify that if the device were 
intended for a use in addition to protecting skin, it would not qualify 
for the exemption. Accordingly, final Sec. 880.5090 states: ``When used 
only as a skin protectant, the device is exempt from premarket 
notification procedures.'' Similarly, FDA has amended final 
Secs. 886.4070 Powered corneal burr and 886.4750 Ophthalmic eye shield 
by adding the word ``only'' to clarify the exemption does not apply 
when the device is used for intended uses not specifically stated in 
the regulation.
    8. Also, on its own initiative, FDA is revising the description of 
the exempted device, rubber dam, in 21 CFR 872.6300(a) to clarify that 
this device does not include a rubber dam, which is intended for 
prevention of sexually transmitted diseases during oral sex. Such a 
device is classified as a condom in 21 CFR 884.5300.

IV. Designation of Devices

    The following devices are devices that FDA believes meet the 
reserved criteria in section 206 of FDAMA and, therefore, FDA is 
codifying the determination that they remain subject to premarket 
notification under new section 510(l) of the act:

                                Table 1--Designations of Reserved Class I Devices
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                 21 CFR Section                                           Name of Device
----------------------------------------------------------------------------------------------------------------
862.1065                                         Ammonia test system
862.1113                                         Bilirubin (total and unbound) in the neonate test system
862.1310                                         Galactose test system
862.1410                                         Iron (non-heme) test system
862.1415                                         Iron-binding capacity test system
862.1495                                         Magnesium test system
862.1580                                         Phosphorous (inorganic) test system
862.1660                                         Quality control material (assayed and unassayed) 1
862.1680                                         Testosterone test system
862.1730                                         Free tyrosine test system
862.1775                                         Uric acid test system
862.3050                                         Breath-alcohol test system
862.3110                                         Antimony test system
862.3120                                         Arsenic test system
862.3220                                         Carbon monoxide test system
862.3240                                         Cholinesterase test system
862.3280                                         Clinical toxicology control material (assayed and unassayed) 1
862.3600                                         Mercury test system
862.3750                                         Quinine test system
862.3850                                         Sulfonamide test system
864.7040                                         Adenosine triphosphate release assay
864.8950                                         Russell viper venom reagent
864.9050                                         Blood bank supplies
864.9125                                         Vacuum-assisted blood collection system 2
864.9195                                         Blood mixing devices and blood weighing devices 2

[[Page 2300]]

 
866.2390                                         Transport culture medium
866.2560                                         Microbial growth monitor 3
866.2850                                         Automated zone reader
866.2900                                         Microbiological specimen collection and transport device
866.3110                                         Campylobacter fetus serological reagents
866.3120                                         Chlamydia serological reagents
866.3235                                         Epstein-Barr virus serological reagents
866.3370                                         Mycobacterium tuberculosis immunofluorescent reagents
866.3870                                         Trypanosoma spp. serological reagents
872.3700                                         Dental mercury
872.4200                                         Dental handpiece and accessories
872.6250                                         Dental chair and accessories 4
872.6640                                         Dental operative unit and accessories 5
872.6710                                         Boiling water sterilizer
876.5160                                         Urological clamps for males 6
878.4460                                         Surgeon's glove
880.5090                                         Liquid bandage 7
880.5680                                         Pediatric position holder
880.6250                                         Patient examination glove
880.6375                                         Patient lubricant
880.6760                                         Protective restraint
882.1030                                         Ataxiagraph
882.1420                                         Electroencephalogram (EEG) signal spectrum analyzer
882.4060                                         Ventricular cannula 8
882.4545                                         Shunt system implantation instrument 9
884.2980(a)                                      Telethermographic system 10
884.2982(a)                                      Liquid crystal thermographic system 11
884.5435                                         Unscented menstrual pads (interlabial pads and reusable
                                                  menstrual pads)
886.4070                                         Powered corneal burr 12
886.4300                                         Intraocular lens guide 13
886.4370                                         Keratome
886.4750                                         Ophthalmic eye shield (when made of other than plastic or
                                                  aluminum)
888.1500                                         Goniometer
890.3850                                         Mechanical wheelchair
890.5710                                         Hot or cold disposable pack 14
892.1100                                         Scintillation (gamma) camera
892.1110                                         Positron camera
----------------------------------------------------------------------------------------------------------------
\1\ Meets reserved criteria for all assayed and only the unassayed when used for donor screening.
\2\ Meets reserved criteria when automated.
\3\ Meets reserved criteria when automated blood culturing systems.
\4\ Meets reserved criteria when dental chair with the operative unit.
\5\ Meets reserved criteria when it is not an accessory to the unit.
\6\ Meets reserved criteria when devices are for internal use or are used for females.
\7\ Meets reserved criteria for uses other than as a skin protectant.
\8\ Meets reserved criteria if not made of surgical grade stainless steel.
\9\ Meets reserved criteria if not made of surgical grade stainless steel.
\10\ Meets reserved criteria if an adjunct use system.
\11\ Meets reserved criteria if nonelectrically powered or AC-powered adjunctive system.
\12\ Meets reserved criteria if for use other than for removing rust rings.
\13\ Meets reserved criteria if used as folders or injectors for soft or foldable intraocular lenses (IOL's).
\14\ Meets reserved criteria if indicated for use on infants.

    FDA is amending the regulations to designate the following devices 
as exempt from premarket notification because FDA believes that they do 
not meet the reserved criteria under new section 510(l) of the act:

                                Table 2--Designations of Exempted Class I Devices
----------------------------------------------------------------------------------------------------------------
                 21 CFR Section                                           Name of Device
----------------------------------------------------------------------------------------------------------------
862.1030                                         Alanine amino transferase (ALT/SGPT) test system
862.1040                                         Aldolase test system
862.1060                                         Delta-aminolevulinic acid test system
862.1075                                         Androstenedione test system
862.1080                                         Androsterone test system
862.1095                                         Ascorbic acid test system
862.1115                                         Urinary bilirubin and its conjugates (nonquantitative) test
                                                  system
862.1130                                         Blood volume test system
862.1135                                         C-peptides of proinsulin test system
862.1165                                         Catecholamines (total) test system
862.1175                                         Cholesterol (total) test
862.1180                                         Chymotrypsin test system
862.1185                                         Compound S (11-deoxycortisol) test system
862.1195                                         Corticoids test system

[[Page 2301]]

 
862.1200                                         Corticosterone test system
862.1240                                         Cystine test system
862.1245                                         Dehydroepiandrosterone (free and sulfate) test system
862.1250                                         Desoxycorticosterone 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
862.1300                                         Follicle-stimulating hormone test system
862.1325                                         Gastrin test system
862.1330                                         Globulin test system
862.1335                                         Glucagon test system
862.1360                                         Gamma-glutamyl transpeptidase and isoenzymes test system
862.1370                                         Human growth hormone test system
862.1375                                         Histidine 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
862.1430                                         17-Ketosteroids test system
862.1435                                         Ketones (nonquantitative) test system
862.1450                                         Lactic acid test system
862.1460                                         Leucine aminopeptidase test system
862.1465                                         Lipase test system
862.1475                                         Lipoprotein test system
862.1485                                         Luteinizing hormone test system
862.1500                                         Malic dehydrogenase test system
862.1505                                         Mucopolysaccharides (nonquantitative) test system
862.1510                                         Nitrite (nonquantitative) 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
862.1550                                         Urinary pH (nonquantitative) test system
862.1560                                         Urinary phenylketones (nonquantitative) test system
862.1570                                         Phosphohexose isomerase test system
862.1590                                         Porphobilinogen test system
862.1595                                         Porphyrins 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
862.1645                                         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) 1
862.1705                                         Triglyceride test system
862.1725                                         Trypsin 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
862.1820                                         Xylose test system
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
862.2250                                         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
862.2400                                         Densitometer/scanner (integrating, reflectance, TLC, or
                                                  radiochromatogram) for clinical use
862.2500                                         Enzyme analyzer for clinical use
862.2540                                         Flame emission photometer for clinical use

[[Page 2302]]

 
862.2560                                         Fluorometer for clinical use
862.2680                                         Microtitrator for clinical use
862.2700                                         Nephelometer for clinical use
862.2730                                         Osmometer for clinical use
862.2750                                         Pipetting and diluting system for clinical use
862.2850                                         Atomic absorption spectrophotometer for clinical use
862.2860                                         Mass spectrometer for clinical use
862.2900                                         Automated urinalysis system
862.3280                                         Clinical toxicology control material (assayed and unassayed) 1
864.2280                                         Cultured animal and human cells
864.3250                                         Specimen transport and storage container
864.5240                                         Automated blood cell diluting apparatus
864.6150                                         Capillary blood collection tube
864.9125                                         Vacuum-assisted blood collection system 2
864.9185                                         Blood grouping view box
864.9195                                         Blood mixing devices and blood weighing devices 2
864.9225                                         Cell-freezing apparatus and reagents for in vitro diagnostic
                                                  use
864.9275                                         Blood bank centrifuge for in vitro diagnostic use
864.9320                                         Copper sulphate solution for specific gravity determinations
864.9750                                         Heat-sealing device
866.2660                                         Microorganism differentiation and identification device
866.3040                                         Aspergillus spp. serological reagents
866.3140                                         Corynebacterium spp. serological reagents
866.3145                                         Coxsackievirus serological reagents
866.3200                                         Echinococcus spp. serological reagents
866.3240                                         Equine encephalomyelitis virus serological reagents
866.3355                                         Listeria spp. serological reagents
866.3360                                         Lymphocytic choriomeningitis virus serological reagents
866.3375                                         Mycoplasma spp. serological reagents
866.3380                                         Mumps virus serological reagents
866.3405                                         Poliovirus serological reagents
866.3480                                         Respiratory syncytial virus serological reagents
866.3500                                         Rickettsia serological reagents
866.3600                                         Schistosoma spp. serological reagents
866.3680                                         Sporothrix schenckii serological reagents
866.3740                                         Streptococcus spp. serological reagents
866.3850                                         Trichinella spiralis serological reagents
866.5060                                         Prealbumin immunological test system
866.5065                                         Human allotypic marker immunological test system
866.5160                                         Beta-globulin immunological test system
866.5200                                         Carbonic anhydrase B and C immunological test
866.5330                                         Factor XIII, A, S, immunological test system 3
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
866.5560                                         Lactic dehydrogenase immunological test system
866.5570                                         Lactoferrin immunological test system
866.5590                                         Lipoprotein X immunological test system
866.5715                                         Plasminogen immunological test system
866.5735                                         Prothrombin immunological test system 4
866.5765                                         Retinol-binding protein immunological test system
866.5890                                         Inter-alpha trypsin inhibitor immunological test system
868.1910                                         Esophageal stethoscope
868.5620                                         Breathing mouthpiece
868.5640                                         Medicinal nonventilatory nebulizer (atomizer)
868.5675                                         Rebreathing device
868.5700                                         Nonpowered oxygen tent
868.6810                                         Tracheobronchial suction catheter
872.3275(a)(1)                                   Dental cement (zinc oxide-eugenol)
872.3400(b)(1)                                   Karaya and sodium borate with or without acacia denture
                                                  adhesive (less than 12 percent sodium borate by weight)
872.3540(b)(1)                                   OTC denture cushion or pad 5
872.6300                                         Rubber dam and accessories 6
872.6390                                         Dental floss
874.1070                                         Short increment sensitivity index (SISI) adapter
874.1100                                         Earphone cushion for audiometric testing
874.1500                                         Gustometer
874.1800                                         Air or water caloric stimulator
874.1925                                         Toynbee diagnostic tube
874.3300(b)(1)                                   Hearing aid 7

[[Page 2303]]

 
874.3540                                         Prosthesis modification instrument for ossicular replacement
                                                  surgery
874.4100                                         Epistaxis balloon
874.4420                                         Ear, nose, and throat manual surgical instrument
874.5300                                         Ear, nose, and throat examination and treatment unit
874.5550                                         Powered nasal irrigator
874.5840                                         Antistammering device
876.5160                                         Urological clamp for males 8
876.5210                                         Enema kit
876.5250(b)(2)                                   Urine collector and accessories 9
876.5980(b)(2)                                   Gastrointestinal tube and accessories 10
878.3250                                         External facial fracture fixation appliance
878.3910                                         Noninflatable extremity splint
878.3925                                         Plastic surgery kit and accessories
878.4040                                         Surgical apparel 11
878.4100                                         Organ bag
878.4200                                         Introduction/drainage catheter and accessories
878.4320                                         Removable skin clip
878.4680                                         Nonpowered, single patient, portable suction apparatus
878.4760                                         Removable skin staple
878.4820                                         Surgical instrument motors and accessories/attachments
878.4960                                         Operating tables and accessories and operating chairs and
                                                  accessories
880.5090                                         Liquid bandage 12
880.5270                                         Neonatal eye pad
880.5420                                         Pressure infusor for an I.V. bag
882.1200                                         Two-point discriminator
882.1500                                         Esthesiometer
882.1750                                         Pinwheel
882.4060                                         Ventricular cannula 13
882.4545                                         Shunt system implantation instrument 14
882.4650                                         Neurosurgical suture needle
882.4750                                         Skull punch 15
884.1040                                         Viscometer for cervical mucus
886.1350                                         Keratoscope
886.1780                                         Retinoscope 16
886.1940                                         Tonometer sterilizer
886.4070                                         Powered corneal burr 17
886.4300                                         Intraocular lens guide 18
886.5850                                         Sunglasses (nonprescription)
890.5180                                         Manual patient rotation bed
890.5710                                         Hot or cold disposable pack 19
892.1300                                         Nuclear rectilinear scanner
892.1320                                         Nuclear uptake probe
892.1330                                         Nuclear whole body scanner
892.1350                                         Nuclear scanning bed
892.1410                                         Nuclear electrocardiograph synchronizer
892.1890                                         Radiographic film illuminator
892.1910                                         Radiographic grid
892.1960                                         Radiographic intensifying screen
892.1970                                         Radiographic ECG/respirator, synchronizer
892.2010                                         Medical image storage device
892.2020                                         Medical image communications device
892.5650                                         Manual radionuclide applicator system
892.6500                                         Personnel protective shield
----------------------------------------------------------------------------------------------------------------
\1\ Exemption is limited to unassayed material, except when used in conjunction with donor screening tests.
\2\ Exemption is limited to manual devices.
\3\ This exemption should not be confused with 21 CFR 864.7290.
\4\ This exemption should not be confused with 21 CFR 864.5425 or 864.7750.
\5\ This exemption does not apply to class III OTC denture cushion as described in 21 CFR 872.3540(b)(2).
\6\ Exemption does not include rubber dam intended for use in preventing transmission of sexually transmitted
  diseases through oral sex. Those devices are classified as condoms in 21 CFR 884.5300.
\7\ Exemption is limited to air-conduction hearing aids.
\8\ Exemption does not include devices for internal use or devices used for females.
\9\ Exemption does not include class II devices for a urine collector and accessories intended to be connected
  to an indwelling catheter as described in 21 CFR 876.5250(b)(1).
\10\ Exemption is limited to dissolvable nasogastric feed tube guide for the nasogastric tube in 21 CFR
  876.5980(b)(2). Exemption does not include class II devices as described in Sec.  876.5980(b)(1).
\11\ Exemption is limited to class I category other than surgical gowns and surgical masks.
\12\ Exemption is limited to uses as a skin protectant.
\13\ Exemption is limited to devices made of surgical grade stainless steel.
\14\ Exemption is limited to devices made of surgical grade stainless steel.
\15\ Exemption should not be confused with 21 CFR 882.4305.
\16\ Exemption is limited to class I battery-powered devices.
\17\ Exemption is limited to rust ring removal.

[[Page 2304]]

 
\18\ Exemption does not apply if used as folders and injectors for soft or foldable IOL's.
\19\ Exemption does not apply if intended for use on infants

V. Environmental Impact

    The agency has determined under 21 CFR 25.30(h) that these actions 
are of a type that do not individually or cumulatively have a 
significant effect on the human environment. Therefore, neither an 
environmental assessment nor an environmental impact statement is 
required.

VI. Analysis of Impacts

    FDA has examined the impacts of the final rule under Executive 
Order 12866, the Regulatory Flexibility Act (5 U.S.C. 601-612), as 
amended by subtitle D of the Small Business Regulatory Fairness Act of 
1996 (Public Law 104-121), and the Unfunded Mandates Reform Act of 1995 
(Public Law 104-4). Executive Order 12866 directs agencies to assess 
all costs and benefits of available regulatory alternatives and, when 
regulation is necessary, to select regulatory approaches that maximize 
net benefits (including potential economic, environmental, public 
health and safety and other advantages distributive impacts and 
equity). The agency believes that this rule is consistent with the 
regulatory philosophy and principles identified in the Executive Order. 
In addition, the rule is not a significant regulatory action as defined 
by the Executive Order and so is not subject to review under the 
Executive Order.
    The Regulatory Flexibility Act requires, if a rule has a 
significant impact on a substantial number of small entities, agencies 
to analyze regulatory options that would minimize any significant 
impact of a rule on small entities. In most cases, the rule would 
reduce a regulatory burden by exempting manufacturers of devices 
subject to the rule from the requirements of premarket notification. 
FDA is requiring premarket notification for three devices that were 
previously exempt from premarket notification. These devices are as 
follows:

A. Ophthalmic Eye Shield (When Made of Other Than Plastic or Aluminum) 
(Sec. 886.4750).

    There are six manufacturers of ophthalmic eye shields other than 
those made of plastic or aluminum registered with FDA. FDA anticipates 
that any premarket notifications that are necessary for these devices 
would be simple because FDA would be primarily interested in 
information about biocompatibility. FDA estimates that preparation of 
such a premarket notification would cost no more than $5,000 and that 
there would be no more than 6 premarket notifications per year for a 
total annual cost of $30,000.
    Six manufacturers are not a substantial number of entities. Based 
on data compiled by the Small Business Administration, optical goods 
firms with fewer than 500 employees have annual receipts of $1,524,000. 
Therefore, the cost per firm of complying with this regulation ($5,000) 
does not have a significant impact on these small entities.

B. Quinine Test System (Sec. 862.3750) and Sulfonamide Test System 
(Sec. 862.3850).

    At this time, there are no firms registered for manufacture of 
these devices.
    In light of the previous discussion, under the Regulatory 
Flexibility Act (5 U.S.C. 605(b)), the agency certifies that the final 
rule will not have a significant economic impact on a substantial 
number of small entities. The rule also does not trigger the 
requirement for a written statement under section 202(a) of the 
Unfunded Mandates Reform Act because it does not impose a mandate that 
results in an expenditure of $100 million or more by State, local, or 
tribal governments in the aggregate, or by the private sector, in any 
one year.

VII. Paperwork Reduction Act of 1995

    FDA concludes that this rule contains no collections of 
information. Therefore, clearance by the Office of Management and 
Budget under the Paperwork Reduction Act of 1995 is not required.

List of Subjects

21 CFR Parts 862, 868, 870, 872, 874, 876, 878, 880, 882, 884, 888, and 
890

    Medical devices.

21 CFR Part 864

    Biologics, Blood, Laboratories, Medical devices, Packaging and 
containers.

21 CFR Part 866

    Biologics, Laboratories, Medical devices.

21 CFR Part 886

    Medical devices, Ophthalmic goods and services.

21 CFR Part 892

    Medical devices, Radiation protection, X-rays.
    Therefore, under the Federal Food, Drug, and Cosmetic Act and under 
authority delegated to the Commissioner of Food and Drugs, 21 CFR parts 
862, 864, 866, 868, 870, 872, 874, 876, 878, 880, 882, 884, 886, 888, 
890, and 892 are amended as follows:

PART 862--CLINICAL CHEMISTRY AND CLINICAL TOXICOLOGY DEVICES

    1. The authority citation for 21 CFR part 862 continues to read as 
follows:

    Authority: 21 U.S.C. 351, 360, 360c, 360e, 360j, 371.
    2. Section 862.9 is revised to read as follows:


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:

[[Page 2305]]

    (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).
    3. Section 862.1030 is amended by revising paragraph (b) to read as 
follows:

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

* * * * *
    (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.
    4. Section 862.1040 is amended by revising paragraph (b) to read as 
follows:

Sec. 862.1040  Aldolase test system.

* * * * *
    (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.
    5. Section 862.1060 is amended by revising paragraph (b) to read as 
follows:

Sec. 862.1060  Delta-aminolevulinic acid test system.

* * * * *
    (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.
    6. Section 862.1075 is amended by revising paragraph (b) to read as 
follows:

Sec. 862.1075  Androstenedione test system.

* * * * *
    (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.
    7. Section 862.1080 is amended by revising paragraph (b) to read as 
follows:

Sec. 862.1080  Androsterone test system.

* * * * *
    (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.
    8. Section 862.1095 is amended by revising paragraph (b) to read as 
follows:

Sec. 862.1095  Ascorbic acid test system.

* * * * *
    (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.
    9. Section 862.1115 is amended by revising paragraph (b) to read as 
follows:

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

* * * * *
    (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.
    10. Section 862.1130 is amended by revising paragraph (b) to read 
as follows:

Sec. 862.1130  Blood volume test system.

* * * * *
    (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.
    11. Section 862.1135 is amended by revising paragraph (b) to read 
as follows:

Sec. 862.1135  C-peptides of proinsulin test system.

* * * * *
    (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.
    12. Section 862.1165 is amended by revising paragraph (b) to read 
follows:

Sec. 862.1165  Catecholamines (total) test system.

* * * * *
    (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.
    13. Section 862.1175 is amended by revising paragraph (b) to read 
as follows:

Sec. 862.1175  Cholesterol (total) test system.

* * * * *
    (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.
    14. Section 862.1180 is amended by revising paragraph (b) to read 
as follows:

Sec. 862.1180  Chymotrypsin test system.

* * * * *
    (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.
    15. Section 862.1185 is amended by revising paragraph (b) to read 
as follows:

Sec. 862.1185  Compound S (11-deoxycortisol) test system.

* * * * *
    (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.
     16. Section 862.1195 is amended by revising paragraph (b) to read 
as follows:

Sec. 862.1195  Corticoids test system.

* * * * *
    (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.
    17. Section 862.1200 is amended by revising paragraph (b) to read 
as follows:

Sec. 862.1200  Corticosterone test system.

* * * * *
    (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.
    18. Section 862.1240 is amended by revising paragraph (b) to read 
as follows:

Sec. 862.1240  Cystine test system.

* * * * *
    (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.
    19. Section 862.1245 is amended by revising paragraph (b) to read 
as follows:

Sec. 862.1245  Dehydroepiandrosterone (free and sulfate) test system.

* * * * *

[[Page 2306]]

    (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.
    20. Section 862.1250 is amended by revising paragraph (b) to read 
as follows:

Sec. 862.1250  Desoxycorticosterone test system.

* * * * *
    (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.
    21. Section 862.1260 is amended by revising paragraph (b) to read 
as follows:


Sec. 862.1260  Estradiol test system.

* * * * *
    (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.
    22. Section 862.1265 is amended by revising paragraph (b) to read 
as follows:

Sec. 862.1265  Estriol test system.

* * * * *
    (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.
    23. Section 862.1270 is amended by revising paragraph (b) to read 
as follows:

Sec. 862.1270  Estrogens (total, in pregnancy) test system.

* * * * *
    (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.
    24. Section 862.1275 is amended by revising paragraph (b) to read 
as follows:

Sec. 862.1275  Estrogens (total, nonpregnancy) test system.

* * * * *
    (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.
    25. Section 862.1280 is amended by revising paragraph (b) to read 
as follows:

Sec. 862.1280  Estrone test system.

* * * * *
    (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.
    26. Section 862.1285 is amended by revising paragraph (b) to read 
as follows:

Sec. 862.1285  Etiocholanolone test system.

* * * * *
    (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.
    27. Section 862.1300 is amended by revising paragraph (b) to read 
as follows:

Sec. 862.1300  Follicle-stimulating hormone test system.

* * * * *
    (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.
    28. Section 862.1325 is amended by revising paragraph (b) to read 
as follows:

Sec. 862.1325  Gastrin test system.

* * * * *
    (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.
    29. Section 862.1330 is amended by revising paragraph (b) to read 
as follows:

Sec. 862.1330  Globulin test system.

* * * * *
    (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.
    30. Section 862.1335 is amended by revising paragraph (b) to read 
as follows:

Sec. 862.1335  Glucagon test system.

* * * * *
    (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.
    31. Section 862.1360 is amended by revising paragraph (b) to read 
as follows:

Sec. 862.1360  Gamma-glutamyl transpeptidase and isoenzymes test 
system.

* * * * *
    (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.
    32. Section 862.1370 is amended by revising paragraph (b) to read 
as follows:

Sec. 862.1370  Human growth hormone test system.

* * * * *
    (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.
    33. Section 862.1375 is amended by revising paragraph (b) to read 
as follows:

Sec. 862.1375  Histidine test system.

* * * * *
    (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.
    34. Section 862.1385 is amended by revising paragraph (b) to read 
as follows:

Sec. 862.1385  17-Hydroxycorticosteroids (17-ketogenic steroids) test 
system.

* * * * *
    (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.
    35. Section 862.1390 is amended by revising paragraph (b) to read 
as follows:

Sec. 862.1390  5-Hydroxyindole acetic acid/serotonin test system.

* * * * *
    (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.
    36. Section 862.1395 is amended by revising paragraph (b) to read 
as follows:


Sec. 862.1395  17-Hydroxyprogesterone test system.

* * * * *
    (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.
    37. Section 862.1400 is amended by revising paragraph (b) to read 
as follows:

Sec. 862.1400  Hydroxyproline test system.

* * * * *
     (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.
    38. Section 862.1405 is amended by revising paragraph (b) to read 
as follows:

Sec. 862.1405  Immunoreactive insulin test system.

* * * * *
     (b) Classification. Class I (general controls). The device is 
exempt from the

[[Page 2307]]

premarket notification procedures in subpart E of part 807 of this 
chapter subject to Sec. 862.9.
    39. Section 862.1430 is amended by revising paragraph (b) to read 
as follows:

Sec. 862.1430  17-Ketosteroids test system.

* * * * *
     (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.
     40. Section 862.1435 is amended by revising paragraph (b) to read 
as follows:

Sec. 862.1435  Ketones (nonquantitative) test system.

* * * * *
    (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.
     41. Section 862.1450 is amended by revising paragraph (b) to read 
as follows:

Sec. 862.1450  Lactic acid test system.

* * * * *
     (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.
     42. Section 862.1460 is amended by revising paragraph (b) to read 
as follows:

Sec. 862.1460  Leucine aminopeptidase test system.

* * * * *
    (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.
     43. Section 862.1465 is amended by revising paragraph (b) to read 
as follows:

Sec. 862.1465  Lipase test system.

* * * * *
     (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.
     44. Section 862.1475 is amended by revising paragraph (b) to read 
as follows:

Sec. 862.1475  Lipoprotein test system.

* * * * *
     (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.
     45. Section 862.1485 is amended by revising paragraph (b) to read 
as follows:

Sec. 862.1485  Luteinizing hormone test system.

* * * * *
     (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.
     46. Section 862.1500 is amended by revising paragraph (b) to read 
as follows:

Sec. 862.1500  Malic dehydrogenase test system.

* * * * *
     (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.
     47. Section 862.1505 is amended by revising paragraph (b) to read 
as follows:

Sec. 862.1505  Mucopolysaccharides (nonquantitative) test system.

* * * * *
     (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.
     48. Section 862.1510 is amended by revising paragraph (b) to read 
as follows:

Sec. 862.1510  Nitrite (nonquantitative) test system.

* * * * *
     (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.
     49. Section 862.1520 is amended by revising paragraph (b) to read 
as follows:

Sec. 862.1520  5'-Nucleotidase test system.

* * * * *
     (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.
     50. Section 862.1530 is amended by revising paragraph (b) to read 
as follows:


Sec. 862.1530  Plasma oncometry test system.

* * * * *
     (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.
     51. Section 862.1535 is amended by revising paragraph (b) to read 
as follows:


Sec. 862.1535  Ornithine carbamyl transferase test system.

* * * * *
     (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. Section 862.1540 is amended by revising paragraph (b) to read 
as follows:


Sec. 862.1540  Osmolality test system.

* * * * *
     (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.
     53. Section 862.1542 is amended by revising paragraph (b) to read 
as follows:


Sec. 862.1542  Oxalate test system.

* * * * *
     (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.
     54. Section 862.1550 is amended by revising paragraph (b) to read 
as follows:


Sec. 862.1550  Urinary pH (nonquantitative) test system.

* * * * *
     (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.
     55. Section 862.1560 is amended by revising paragraph (b) to read 
as follows:


Sec. 862.1560  Urinary phenylketones (nonquantitative) test system.

* * * * *
     (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.
     56. Section 862.1570 is amended by revising paragraph (b) to read 
as follows:


Sec. 862.1570  Phosphohexose isomerase test system.

* * * * *
     (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.
     57. Section 862.1590 is amended by revising paragraph (b) to read 
as follows:


Sec. 862.1590  Porphobilinogen test system.

* * * * *
     (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.
     58. Section 862.1595 is amended by revising paragraph (b) to read 
as follows:


Sec. 862.1595  Porphyrins test system.

* * * * *

[[Page 2308]]

     (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.
     59. Section 862.1605 is amended by revising paragraph (b) to read 
as follows:


Sec. 862.1605  Pregnanediol test system.

* * * * *
     (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.
     60. Section 862.1610 is amended by revising paragraph (b) to read 
as follows:


Sec. 862.1610  Pregnanetriol test system.

* * * * *
     (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.
     61. Section 862.1615 is amended by revising paragraph (b) to read 
as follows:


Sec. 862.1615  Pregnenolone test system.

* * * * *
     (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.
     62. Section 862.1620 is amended by revising paragraph (b) to read 
as follows:


Sec. 862.1620  Progesterone test system.

* * * * *
     (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.
     63. Section 862.1625 is amended by revising paragraph (b) to read 
as follows:


Sec.  862.1625  Prolactin (lactogen) test system.

* * * * *
     (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.
     64. Section 862.1630 is amended by revising paragraph (b) to read 
as follows:


Sec. 862.1630  Protein (fractionation) test system.

* * * * *
     (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.
     65. Section 862.1645 is amended by revising paragraph (b) to read 
as follows:


Sec. 862.1645  Urinary protein or albumin (nonquantitative) test 
system.

* * * * *
     (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.
     66. Section 862.1650 is amended by revising paragraph (b) to read 
as follows:


Sec. 862.1650  Pyruvate kinase test system.

* * * * *
     (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.
     67. Section 862.1655 is amended by revising paragraph (b) to read 
as follows:


Sec. 862.1655  Pyruvic acid test system.

* * * * *
     (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.
     68. Section 862.1660 is amended by revising paragraph (b) to read 
as follows:


Sec. 862.1660  Quality control material (assayed and unassayed).

* * * * *
     (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.
     69. Section 862.1705 is amended by revising paragraph (b) to read 
as follows:


Sec. 862.1705  Triglyceride test system.

* * * * *
     (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.
     70. Section 862.1725 is amended by revising paragraph (b) to read 
as follows:


Sec. 862.1725  Trypsin test system.

* * * * *
     (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.
     71. Section 862.1780 is amended by revising paragraph (b) to read 
as follows:


Sec. 862.1780  Urinary calculi (stones) test system.

* * * * *
     (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.
     72. Section 862.1785 is amended by revising paragraph (b) to read 
as follows:


Sec. 862.1785  Urinary urobilinogen (nonquantitative) test system.

* * * * *
     (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.
     73. Section 862.1790 is amended by revising paragraph (b) to read 
as follows:


Sec. 862.1790  Uroporphyrin test system.

* * * * *
     (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.
     74. Section 862.1795 is amended by revising paragraph (b) to read 
as follows:


Sec. 862.1795  Vanilmandelic acid test system.

* * * * *
     (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.
     75. Section 862.1805 is amended by revising paragraph (b) to read 
as follows:


Sec. 862.1805  Vitamin A test system.

* * * * *
     (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.
     76. Section 862.1820 is amended by revising paragraph (b) to read 
as follows:


Sec. 862.1820  Xylose test system.

* * * * *
     (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.
     77. Section 862.2140 is amended by revising paragraph (b) to read 
as follows:


Sec. 862.2140   Centrifugal chemistry analyzer for clinical 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. 862.9.
     78. Section 862.2150 is amended by revising paragraph (b) to read 
as follows:


Sec. 862.2150  Continuous flow sequential multiple chemistry analyzer 
for clinical use.

* * * * *
     (b)  Classification. Class I (general controls). The device is 
exempt from the

[[Page 2309]]

premarket notification procedures in subpart E of part 807 of this 
chapter subject to Sec. 862.9.
     79. Section 862.2160 is amended by revising paragraph (b) to read 
as follows:


Sec. 862.2160  Discrete photometric chemistry analyzer for clinical 
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. 862.9.
     80. Section 862.2170 is amended by revising paragraph (b) to read 
as follows:


Sec. 862.2170  Micro chemistry analyzer for clinical 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. 862.9.
     81. Section 862.2250 is amended by revising paragraph (b) to read 
as follows:


Sec. 862.2250  Gas liquid chromatography system for clinical 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. 862.9.
     82. Section 862.2260 is amended by revising paragraph (b) to read 
as follows:


Sec. 862.2260   High pressure liquid chromatography system for clinical 
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. 862.9.
     83. Section 862.2270 is amended by revising paragraph (b) to read 
as follows:


Sec. 862.2270  Thin-layer chromatography system for clinical 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. 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.
     84. Section 862.2300 is amended by revising paragraph (b) to read 
as follows:


Sec. 862.2300  Colorimeter, photometer, or spectrophotometer for 
clinical 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. 862.9.
     85. Section 862.2400 is amended by revising paragraph (b) to read 
as follows:


Sec. 862.2400  Densitometer/scanner (integrating, reflectance, TLC, or 
radiochromatogram) for clinical 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. 862.9.
     86. Section 862.2500 is amended by revising paragraph (b) to read 
as follows:


Sec. 862.2500  Enzyme analyzer for clinical 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. 862.9.
     87. Section 862.2540 is amended by revising paragraph (b) to read 
as follows:


Sec. 862.2540  Flame emission photometer for clinical 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. 862.9.
     88. Section 862.2560 is amended by revising paragraph (b) to read 
as follows:


Sec. 862.2560  Fluorometer for clinical 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. 862.9.
     89. Section 862.2680 is amended by revising paragraph (b) to read 
as follows:


Sec. 862.2680  Microtitrator for clinical 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. 862.9.
     90. Section 862.2700 is amended by revising paragraph (b) to read 
as follows:


Sec. 862.2700  Nephelometer for clinical 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. 862.9.
     91. Section 862.2730 is amended by revising paragraph (b) to read 
as follows:


Sec. 862.2730   Osmometer for clinical 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. 862.9.
     92. Section 862.2750 is amended by revising paragraph (b) to read 
as follows:


Sec. 862.2750  Pipetting and diluting system for clinical 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. 862.9.
     93. Section 862.2850 is amended by revising paragraph (b) to read 
as follows:


Sec. 862.2850  Atomic absorption spectrophotometer for clinical 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. 862.9.
     94. Section 862.2860 is amended by revising paragraph (b) to read 
as follows:


Sec. 862.2860  Mass spectrometer for clinical 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. 862.9.
     95. Section 862.2900 is amended by revising paragraph (b) to read 
as follows:


Sec. 862.2900  Automated urinalysis system.

* * * * *
     (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.
     96. Section 862.3280 is amended by revising paragraph (b) to read 
as follows:


Sec. 862.3280  Clinical toxicology control material.

* * * * *
     (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.
     97. Section 862.3750 is amended by revising paragraph (b) to read 
as follows:

[[Page 2310]]

Sec. 862.3750  Quinine test system.

* * * * *
     (b) Classification. Class I.
     98. Section 862.3850 is amended by revising paragraph (b) to read 
as follows:


Sec. 862.3850  Sulfonamide test system.

* * * * *
     (b) Classification. Class I.

PART 864--HEMATOLOGY AND PATHOLOGY DEVICES

     99. The authority citation for 21 CFR part 864 continues to read 
as follows:

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

    100. Section 864.9 is revised to read as follows:


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 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).
    101. Section 864.2280 is amended by revising paragraph (b) to read 
as follows:


Sec. 864.2280  Cultured animal and human cells.

* * * * *
     (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.
     102. Section 864.3250 is amended by revising paragraph (b) to read 
as follows:


Sec. 864.3250  Specimen transport and storage 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.
     103. Section 864.5240 is amended by revising paragraph (b) to read 
as follows:


Sec. 864.5240  Automated blood cell diluting apparatus.

* * * * *
     (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.
     104. Section 864.6150 is amended by revising paragraph (b) to read 
as follows:


Sec. 864.6150  Capillary blood collection tube.

* * * * *
     (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.
     105. Section 864.9125 is amended by revising paragraph (b) to read 
as follows:


Sec. 864.9125  Vacuum-assisted blood collection system.

* * * * *
     (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.
     106. Section 864.9185 is amended by revising paragraph (b) to read 
as follows:


Sec. 864.9185  Blood grouping view box.

* * * * *
     (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.
     107. Section 864.9195 is amended by revising paragraph (b) to read 
as follows:


Sec. 864.9195  Blood mixing devices and blood weighing devices.

* * * * *
     (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.
     108. Section 864.9225 is amended by revising paragraph (b) to read 
as follows:


Sec. 864.9225  Cell-freezing apparatus and reagents 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.
     109. Section 864.9275 is amended by revising paragraph (b) to read 
as follows:


Sec. 864.9275  Blood bank centrifuge 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.
     110. Section 864.9320 is amended by revising paragraph (b) to read 
as follows:

[[Page 2311]]

Sec. 864.9320  Copper sulfate solution for specific gravity 
determinations.

* * * * *
     (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.
     111. Section 864.9750 is amended by revising paragraph (b) to read 
as follows:


Sec. 864.9750  Heat-sealing device.

* * * * *
     (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.

PART 866--IMMUNOLOGY AND MICROBIOLOGY DEVICES

     112. The authority citation for 21 CFR part 866 continues to read 
as follows:

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

    113. Section 866.9 is revised to read as follows:


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;
    (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).
     114. Section 866.2660 is amended by revising paragraph (b) to read 
as follows:


Sec. 866.2660  Microorganism differentiation and identification device.

* * * * *
     (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.
     115. Section 866.3040 is amended by revising paragraph (b) to read 
as follows:


Sec. 866.3040  Aspergillus spp. serological reagents.

* * * * *
     (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.
     116. Section 866.3140 is amended by revising paragraph (b) to read 
as follows:


Sec. 866.3140  Corynebacterium spp. serological reagents.

* * * * *
     (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.
     117. Section 866.3145 is amended by revising paragraph (b) to read 
as follows:


Sec. 866.3145  Coxsackievirus serological reagents.

* * * * *
     (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.
     118. Section 866.3200 is amended by revising paragraph (b) to read 
as follows:


Sec. 866.3200  Echinococcus spp. serological reagents.

* * * * *
     (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.
     119. Section 866.3240 is amended by revising paragraph (b) to read 
as follows:


Sec. 866.3240  Equine encephalomyelitis virus serological reagents.

* * * * *
     (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.
     120. Section 866.3355 is amended by revising paragraph (b) to read 
as follows:


Sec. 866.3355  Listeria spp. serological reagents.

* * * * *
     (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.
     121. Section 866.3360 is amended by revising paragraph (b) to read 
as follows:


Sec. 866.3360  Lymphocytic choriomeningitis virus serological reagents.

* * * * *
     (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.
     122. Section 866.3375 is amended by revising paragraph (b) to read 
as follows:


Sec. 866.3375  Mycoplasma spp. serological reagents.

* * * * *
     (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.
     123. Section 866.3380 is amended by revising paragraph (b) to read 
as follows:

[[Page 2312]]

Sec. 866.3380  Mumps virus serological reagents.

* * * * *
     (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.
     124. Section 866.3405 is amended by revising paragraph (b) to read 
as follows:


Sec. 866.3405  Poliovirus serological reagents.

* * * * *
     (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.
     125. Section 866.3480 is amended by revising paragraph (b) to read 
as follows:


Sec. 866.3480  Respiratory syncytial virus serological reagents.

* * * * *
     (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.
     126. Section 866.3500 is amended by revising paragraph (b) to read 
as follows:


Sec. 866.3500  Rickettsia serological reagents.

* * * * *
     (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.
     127. Section 866.3600 is amended by revising paragraph (b) to read 
as follows:


Sec. 866.3600  Schistosoma spp. serological reagents.

* * * * *
     (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.
     128. Section 866.3680 is amended by revising paragraph (b) to read 
as follows:


Sec. 866.3680  Sporothrix schenckii serological reagents.

* * * * *
     (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.
    129. Section 866.3740 is amended by revising paragraph (b) to read 
as follows:


Sec. 866.3740  Streptococcus spp. serological reagents.

* * * * *
     (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.
     130. Section 866.3850 is amended by revising paragraph (b) to read 
as follows:


Sec. 866.3850  Trichinella spiralis serological reagents.

* * * * *
     (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.
     131. Section 866.5060 is amended by revising paragraph (b) to read 
as follows:


Sec. 866.5060  Prealbumin immunological test system.

* * * * *
     (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.
     132. Section 866.5065 is amended by revising paragraph (b) to read 
as follows:


Sec. 866.5065  Human allotypic marker immunological test system.

* * * * *
     (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.
     133. Section 866.5160 is amended by revising paragraph (b) to read 
as follows:


Sec. 866.5160  Beta-globulin immunological test system.

* * * * *
     (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.
     134. Section 866.5200 is amended by revising paragraph (b) to read 
as follows:


Sec. 866.5200  Carbonic anhydrase B and C immunological test system.

* * * * *
     (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.
     135. Section 866.5330 is amended by revising paragraph (b) to read 
as follows:


Sec. 866.5330  Factor XIII, A, S, immunological test system.

* * * * *
     (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. This exemption does not 
apply to factor deficiency tests classified under Sec. 864.7290 of this 
chapter.
    136. Section 866.5400 is amended by revising paragraph (b) to read 
as follows:


Sec. 866.5400  Alpha-globulin immunological test system.

* * * * *
     (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.
     137. Section 866.5420 is amended by revising paragraph (b) to read 
as follows:


Sec. 866.5420  Alpha-1-glycoproteins immunological test system.

* * * * *
     (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.
     138. Section 866.5425 is amended by revising paragraph (b) to read 
as follows:

Sec. 866.5425  Alpha-2-glycoproteins immunological test system.

* * * * *
     (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.
     139. Section 866.5430 is amended by revising paragraph (b) to read 
as follows:


Sec. 866.5430  Beta-2-glycoprotein I immunological test system.

* * * * *
     (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.
     140. Section 866.5440 is amended by revising paragraph (b) to read 
as follows:


Sec. 866.5440  Beta-2-glycoprotein III immunological test system.

* * * * *
     (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.
     141. Section 866.5560 is amended by revising paragraph (b) to read 
as follows:


Sec. 866.5560  Lactic dehydrogenase immunological test system.

* * * * *
     (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.
     142. Section 866.5570 is amended by revising paragraph (b) to read 
as follows:

[[Page 2313]]

Sec. 866.5570  Lactoferrin immunological test system.

* * * * *
     (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.
     143. Section 866.5590 is amended by revising paragraph (b) to read 
as follows:


Sec. 866.5590  Lipoprotein X immunological test system.

* * * * *
     (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.
     144. Section 866.5715 is amended by revising paragraph (b) to read 
as follows:


Sec. 866.5715  Plasminogen immunological test system.

* * * * *
     (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.
     145. Section 866.5735 is amended by revising paragraph (b) to read 
as follows:


Sec. 866.5735  Prothrombin immunological test system.

* * * * *
     (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. This exemption does not 
apply to multipurpose systems for in vitro coagulation studies 
classified under Sec. 864.5425 of this chapter or prothrombin time 
tests classified under Sec. 864.7750 of this chapter.
     146. Section 866.5765 is amended by revising paragraph (b) to read 
as follows:


Sec. 866.5765  Retinol-binding protein immunological test system.

* * * * *
     (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.
     147. Section 866.5890 is amended by revising paragraph (b) to read 
as follows:


Sec. 866.5890  Inter-alpha trypsin inhibitor immunological test system.

* * * * *
     (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.

PART 868--ANESTHESIOLOGY DEVICES

     148. The authority citation for 21 CFR part 868 continues to read 
as follows:

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

    149. Section 868.9 is revised to read as follows:


Sec. 868.9  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).
     150. Section 868.1910 is amended by revising paragraph (b) to read 
as follows:


Sec. 868.1910  Esophageal stethoscope.

* * * * *
     (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. 868.9.
     151. Section 868.5620 is amended by revising paragraph (b) to read 
as follows:


Sec. 868.5620  Breathing mouthpiece.

* * * * *
     (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. 868.9.
     152. Section 868.5640 is amended by revising paragraph (b) to read 
as follows:


Sec. 868.5640  Medicinal nonventilatory nebulizer (atomizer).

* * * * *
     (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. 868.9.
     153. Section 868.5675 is amended by revising paragraph (b) to read 
as follows:


Sec. 868.5675  Rebreathing device.

* * * * *
     (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. 868.9.
     154. Section 868.5700 is amended by revising paragraph (b) to read 
as follows:


Sec. 868.5700  Nonpowered oxygen tent.

* * * * *
     (b) Classification. Class I (general controls). The device is 
exempt from the premarket notification procedures in

[[Page 2314]]

subpart E of part 807 of this chapter subject to Sec. 868.9.
     155. Section 868.6810 is amended by revising paragraph (b) to read 
as follows:


Sec. 868.6810  Tracheobronchial suction catheter.

* * * * *
     (b)  Classification. Class 1 (general controls). The device is 
exempt from the premarket notification procedures in subpart E of part 
807 of this chapter subject to Sec. 868.9.

 PART 870--CARDIOVASCULAR DEVICES

     156. The authority citation for 21 CFR part 870 continues to read 
as follows:

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

    157. Section 870.9 is revised to read as follows:


Sec. 870.9  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).

PART 872--DENTAL DEVICES

     158. The authority citation for 21 CFR part 872 continues to read 
as follows:

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

     159. Section 872.9 is revised to read as follows:


Sec. 872.9  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).
     160. Section 872.3275 is amended by revising paragraph (a)(2) to 
read as follows:


Sec. 872.3275  Dental cement.

    (a) * * *
     (2) 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. 872.9.
* * * * *

[[Page 2315]]

     161. Section 872.3400 is amended by revising paragraph (b)(1) to 
read as follows:


Sec. 872.3400  Karaya and sodium borate with or without acacia denture 
adhesive.

* * * * *
     (b) Classification. (1) Class I (general controls) if the device 
contains less than 12 percent by weight of sodium borate. The class I 
device is exempt from the premarket notification procedures in subpart 
E of part 807 of this chapter subject to Sec. 872.9.
* * * * *
     162. Section 872.3540 is amended by revising paragraph (b)(1) to 
read as follows:


Sec. 872.3540  OTC denture cushion or pad.

* * * * *
     (b) Classification. (1) Class I if the device is made of wax-
impregnated cotton cloth that the patient applies to the base or inner 
surface of a denture before inserting the denture into the mouth. The 
device is intended to be discarded following 1 day's use. The class I 
device is exempt from the premarket notification procedures in subpart 
E of part 807 of this chapter subject to Sec. 872.9.
* * * * *
     163. Section 872.6300 is revised to read as follows:


Sec. 872.6300  Rubber dam and accessories.

     (a) Identification. A rubber dam and accessories is a device 
composed of a thin sheet of latex with a hole in the center intended to 
isolate a tooth from fluids in the mouth during dental procedures, such 
as filling a cavity preparation. The device is stretched around a tooth 
by inserting a tooth through a hole in the center. The device includes 
the rubber dam, rubber dam clamp, rubber dam frame, and forceps for a 
rubber dam clamp. This classification does not include devices intended 
for use in preventing transmission of sexually transmitted diseases 
through oral sex; those devices are classified as condoms in 
Sec. 884.5300 of this chapter.
     (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. 872.9. 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.
     164. Section 872.6390 is amended by revising paragraph (b) to read 
as follows:


Sec. 872.6390  Dental floss.

* * * * *
     (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. 872.9.
     165. Section 872.6640 is amended by revising paragraph (b) to read 
as follows:


Sec. 872.6640  Dental operative unit and accessories.

* * * * *
     (b) Classification. Class I (general controls). Except for dental 
operative unit, accessories are exempt from premarket notification 
procedures in subpart E of part 807 of this chapter subject to 
Sec. 872.9.

PART 874--EAR, NOSE, AND THROAT DEVICES

     166. The authority citation for 21 CFR part 874 continues to read 
as follows:

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

     167. Section 874.9 is revised to read as follows:


Sec. 874.9  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).
     168. Section 874.1070 is amended by revising paragraph (b) to read 
as follows:


Sec. 874.1070  Short increment sensitivity index (SISI) adapter.

* * * * *
     (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. 874.9.
     169. Section 874.1100 is amended by revising paragraph (b) to read 
as follows:


Sec. 874.1100  Earphone cushion for audiometric 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. 874.9.
     170. Section 874.1500 is amended by revising paragraph (b) to read 
as follows:


Sec. 874.1500  Gustometer.

* * * * *

[[Page 2316]]

     (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. 874.9. 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.
     171. Section 874.1800 is amended by revising paragraph (b) to read 
as follows:


Sec. 874.1800  Air or water caloric stimulator.

* * * * *
     (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. 874.9.
     172. Section 874.1925 is amended by revising paragraph (b) to read 
as follows:


Sec. 874.1925  Toynbee diagnostic tube.

* * * * *
     (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. 874.9.
     173. Section 874.3300 is amended by revising paragraph (b) to read 
as follows:


Sec. 874.3300  Hearing Aid.

* * * * *
     (b) Classification. (1) Class I (general controls) for the air-
conduction hearing aid. The air-conduction hearing aid is exempt from 
the premarket notification procedures in subpart E of part 807 of this 
chapter subject to Sec. 874.9.
    (2) Class II for the bone-conduction hearing aid.
     174. Section 874.3540 is amended by revising paragraph (b) to read 
as follows:


Sec. 874.3540  Prosthesis modification instrument for ossicular 
replacement surgery.

* * * * *
     (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. 874.9. 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.
     175. Section 874.4100 is amended by revising paragraph (b) to read 
as follows:


Sec. 874.4100  Epistaxis balloon.

* * * * *
    (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. 874.9.
     176. Section 874.4420 is amended by revising paragraph (b) to read 
as follows:


Sec. 874.4420  Ear, nose, and throat manual surgical instrument.

* * * * *
     (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. 874.9.
     177. Section 874.5300 is amended by revising paragraph (b) to read 
as follows:


Sec. 874.5300  Ear, nose, and throat examination and treatment unit.

* * * * *
    (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. 874.9.
     178. Section 874.5550 is amended by revising paragraph (b) to read 
as follows:


Sec. 874.5550  Powered nasal irrigator.

* * * * *
     (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. 874.9.
     179. Section 874.5840 is amended by revising paragraph (b) to read 
as follows:


Sec. 874.5840  Antistammering device.

* * * * *
     (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. 874.9.

PART 876--GASTROENTEROLOGY-UROLOGY DEVICES

     180. The authority citation for 21 CFR part 876 continues to read 
as follows:

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

     181. Section 876.9 is revised to read as follows:


Sec. 876.9  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

[[Page 2317]]

    (9) For near patient testing (point of care).
     182. Section 876.5160 is amended by revising paragraph (b) to read 
as follows:


Sec. 876.5160  Urological clamp for males.

* * * * *
     (b) Classification. Class I (general controls). Except when 
intended for internal use or use on females, the device is exempt from 
the premarket notification procedures in subpart E of part 807 of this 
chapter subject to Sec. 876.9.
     183. Section 876.5210 is amended by revising paragraph (b) to read 
as follows:


Sec. 876.5210  Enema kit.

* * * * *
     (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. 876.9. The device 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.
     184. Section 876.5250 is amended by revising paragraph (b)(2) to 
read as follows:


Sec. 876.5250  Urine collector and accessories.

* * * * *
     (b) * * *
     (2) Class I (general controls) for a urine collector and 
accessories not intended to be connected to an indwelling catheter. The 
class I device is exempt from the premarket notification procedures in 
subpart E of part 807 of this chapter subject to Sec. 876.9. 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 the general requirements concerning records, and 
Sec. 820.198 of this chapter, with respect to complaint files.
     185. Section 876.5980 is amended by revising paragraph (b)(2) to 
read as follows:


Sec. 876.5980  Gastrointestinal tube and accessories.

* * * * *
     (b) * * *
     (2) Class I (general controls) for the dissolvable nasogastric 
feed tube guide for the nasogastric tube. The class I device is exempt 
from the premarket notification procedures in subpart E of part 807 of 
this chapter subject to Sec. 876.9.

PART 878--GENERAL AND PLASTIC SURGERY DEVICES

     186. The authority citation for 21 CFR part 878 continues to read 
as follows:

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

     187. Section 878.9 is revised to read as follows:


Sec. 878.9  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).
    188. Section 878.3250 is amended by revising paragraph (b) to read 
as follows:


Sec. 878.3250  External facial fracture fixation appliance.

* * * * *
     (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. 878.9.
     189. Section 878.3910 is amended by revising paragraph (b) to read 
as follows:


Sec. 878.3910  Noninflatable extremity splint.

* * * * *
     (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. 878.9. 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.
     190. Section 878.3925 is amended by revising paragraph (b) to read 
as follows:


Sec. 878.3925  Plastic surgery kit and accessories.

* * * * *
     (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. 878.9.
     191. Section 878.4040 is amended by revising paragraph (b) to read 
as follows:

[[Page 2318]]

Sec. 878.4040  Surgical apparel.

* * * * *
     (b) Classification. (1) Class II (special controls) for surgical 
gowns and surgical masks.
     (2) Class I (general controls) for surgical apparel other than 
surgical gowns and surgical masks. The class I device is exempt from 
the premarket notification procedures in subpart E of part 807 of this 
chapter subject to Sec. 878.9.
     192. Section 878.4100 is amended by revising paragraph (b) to read 
as follows:


Sec. 878.4100  Organ bag.

* * * * *
     (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. 878.9.
     193. Section 878.4200 is amended by revising paragraph (b) to read 
as follows:


Sec. 878.4200  Introduction/drainage catheter and accessories.

* * * * *
     (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. 878.9.
     194. Section 878.4320 is amended by revising paragraph (b) to read 
as follows:


Sec. 878.4320  Removable skin clip.

* * * * *
     (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. 878.9.
     195. Section 878.4680 is amended by revising paragraph (b) to read 
as follows:


Sec. 878.4680  Nonpowered, single patient, portable suction apparatus.

* * * * *
     (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. 878.9.
     196. Section 878.4760 is amended by revising paragraph (b) to read 
as follows:


Sec. 878.4760  Removable skin staple.

* * * * *
     (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. 878.9.
     197. Section 878.4820 is amended by revising paragraph (b) to read 
as follows:


Sec. 878.4820  Surgical instrument motors and accessories/attachments.

* * * * *
     (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. 878.9.
     198. Section 878.4960 is amended by revising paragraph (b) to read 
as follows:


Sec. 878.4960  Operating tables and accessories and operating chairs 
and accessories.

* * * * *
     (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. 878.9.

PART 880--GENERAL HOSPITAL AND PERSONAL USE DEVICES

     199. The authority citation for 21 CFR part 880 continues to read 
as follows:

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

     200. Section 880.9 is revised to read as follows:


Sec. 880.9  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).
     201. Section 880.5090 is amended by revising paragraph (b) to read 
as follows:


Sec. 880.5090  Liquid bandage.

* * * * *
    (b) Classification. Class I (general controls). When used only as a 
skin protectant, the device is exempt from the premarket notification 
procedures in subpart E of part 807 of this chapter subject to 
Sec. 880.9.
     202. Section 880.5270 is amended by revising paragraph (b) to read 
as follows:


Sec. 880.5270  Neonatal eye pad.

* * * * *
     (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. 880.9. 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.

[[Page 2319]]

    203. Section 880.5420 is amended by revising paragraph (b) to read 
as follows:


Sec. 880.5420  Pressure infusor for an I.V. bag.

* * * * *
    (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. 880.9.

PART 882--NEUROLOGICAL DEVICES

     204. The authority citation for 21 CFR part 882 continues to read 
as follows:

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

     205. Section 882.9 is revised to read as follows:


Sec. 882.9  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).
     206. Section 882.1200 is amended by revising paragraph (b) to read 
as follows:


Sec. 882.1200  Two-point discriminator.

* * * * *
     (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. 882.9. 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 of this chapter, with 
respect to general requirements concerning records, and Sec. 820.198 of 
this chapter, with respect to complaint files.
    207. Section 882.1500 is amended by revising paragraph (b) to read 
as follows:


Sec. 882.1500  Esthesiometer.

* * * * *
     (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. 882.9. 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 of this chapter, with 
respect to general requirements concerning records, and Sec. 820.198 of 
this chapter, with respect to complaint files.
     208. Section 882.1750 is amended by revising paragraph (b) to read 
as follows:


Sec. 882.1750  Pinwheel.

* * * * *
     (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. 882.9.
     209. Section 882.4060 is amended by revising paragraph (b) to read 
as follows:


Sec. 882.4060  Ventricular cannula.

* * * * *
     (b) Classification. Class I (general controls). When made only of 
surgical grade stainless steel, the device is exempt from the premarket 
notification procedures in subpart E of part 807 of this chapter 
subject to Sec. 882.9.
     210. Section 882.4545 is amended by revising paragraph (b) to read 
as follows:


Sec. 882.4545  Shunt system implantation instrument.

* * * * *
     (b) Classification. Class I (general controls). When made only of 
surgical grade stainless steel, the device is exempt from the premarket 
notification procedures in subpart E of part 807 of this chapter 
subject to Sec. 882.9.
     211. Section 882.4650 is amended by revising paragraph (b) to read 
as follows:


Sec. 882.4650  Neurosurgical suture needle.

* * * * *
     (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. 882.9.
     212. Section 882.4750 is amended by revising paragraph (b) to read 
as follows:


Sec. 882.4750  Skull punch.

* * * * *
     (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. 882.9. This exemption does not 
apply to powered compound cranial drills, burrs, trephines, and their 
accessories classified under Sec. 882.4305.

PART 884--OBSTETRICAL AND GYNECOLOGICAL DEVICES

     213. The authority citation for 21 CFR part 884 continues to read 
as follows:

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

     214. Section 884.9 is revised to read as follows:


Sec. 884.9  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

[[Page 2320]]

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).
     215. Section 884.1040 is amended by revising paragraph (b) to read 
as follows:


Sec. 884.1040  Viscometer for cervical mucus.

* * * * *
     (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. 884.9.


Sec. 884.5435  [Amended]

    216. Section 884.5435 Unscented menstrual pad is amended in the 
last sentence of paragraph (b) by removing the word ``intralabial'' and 
adding in its place the word ``interlabial''.

PART 886--OPHTHALMIC DEVICES

    217. The authority citation for 21 CFR part 886 continues to read 
as follows:

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

     218. Section 886.9 is revised to read as follows:


Sec. 886.9  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).
    219. Section 886.1350 is amended by revising paragraph (b) to read 
as follows:


Sec. 886.1350  Keratoscope.

* * * * *
    (b) The device is exempt from the premarket notification procedures 
in subpart E of part 807 of this chapter subject to Sec. 886.9. The 
battery-powered device 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
    220. Section 886.1780 is amended by revising paragraph (b) to read 
as follows:


Sec. 886.1780  Retinoscope.

* * * * *
     (b) Classification. (1) Class II (special controls) for the AC-
powered device.
     (2) Class I (general controls) for the battery-powered device. The 
class I

[[Page 2321]]

battery-powered device is exempt from the premarket notification 
procedures in subpart E of part 807 of this chapter subject to 
Sec. 886.9. The battery-powered device 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.
     221. Section 886.1940 is amended by revising paragraph (b) to read 
as follows:


Sec. 886.1940  Tonometer sterilizer.

* * * * *
     (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. 886.9.
     222. Section 886.4070 is amended by revising paragraph (b) to read 
as follows:


Sec. 886.4070  Powered corneal burr.

* * * * *
     (b) Classification. Class I (general controls). When intended only 
for rust ring removal, the device is exempt from the premarket 
notification procedures in subpart E of part 807 of this chapter 
subject to Sec. 886.9.
     223. Section 886.4300 is amended by revising paragraph (b) to read 
as follows:


Sec. 886.4300  Intraocular lens guide.

* * * * *
     (b) Classification. Class I (general controls). Except when used 
as folders or injectors for soft or foldable intraocular lenses, the 
device is exempt from the premarket notification procedures in subpart 
E of part 807 of this chapter subject to Sec. 886.9.
     224. Section 886.4750 is amended by revising paragraph (b) to read 
as follows:


Sec. 886.4750  Ophthalmic eye shield.

* * * * *
     (b) Classification. Class I (general controls). When made only of 
plastic or aluminum, the device is exempt from the premarket 
notification procedures in subpart E of part 807 of this chapter 
subject to Sec. 886.9. When made only of plastic or aluminum, the 
devices 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.
     225. Section 886.5850 is amended by revising paragraph (b) to read 
as follows:


Sec. 886.5850  Sunglasses (nonprescription).

* * * * *
     (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. 886.9.

PART 888--ORTHOPEDIC DEVICES

     226. The authority citation for 21 CFR part 888 continues to read 
as follows:

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

    227. Section 888.9 is revised to read as follows:


Sec. 888.9  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).

PART 890--PHYSICAL MEDICINE DEVICES

     228. The authority citation for 21 CFR part 890 continues to read 
as follows:

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

     229. Section 890.9 is revised to read as follows:


Sec. 890.9  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

[[Page 2322]]

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).
     230. Section 890.5180 is amended by revising paragraph (b) to read 
as follows:


Sec. 890.5180  Manual patient rotation bed.

* * * * *
     (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. 890.9.
     231. Section 890.5710 is amended by revising paragraph (b) to read 
as follows:


Sec. 890.5710  Hot or cold disposable pack.

* * * * *
     (b) Classification. Class I (general controls). Except when 
intended for use on infants, the device is exempt from the premarket 
notification procedures in subpart E of part 807 of this chapter 
subject to Sec. 890.9.

PART 892--RADIOLOGY DEVICES

     232. The authority citation for 21 CFR part 892 continues to read 
as follows:

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

     233. Section 892.9 is revised to read as follows:


Sec. 892.9  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).
     234. Section 892.1300 is amended by revising paragraph (b) to read 
as follows:


Sec. 892.1300  Nuclear rectilinear scanner.

* * * * *
     (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. 892.9.
     235. Section 892.1320 is amended by revising paragraph (b) to read 
as follows:


Sec. 892.1320  Nuclear uptake probe.

* * * * *
     (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. 892.9.
     236. Section 892.1330 is amended by revising paragraph (b) to read 
as follows:


Sec. 892.1330  Nuclear whole body scanner.

* * * * *
     (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. 892.9.
     237. Section 892.1350 is amended by revising paragraph (b) to read 
as follows:


Sec. 892.1350  Nuclear scanning bed.

* * * * *
     (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. 892.9.
     238. Section 892.1410 is amended by revising paragraph (b) to read 
as follows:


Sec. 892.1410  Nuclear electrocardiograph synchronizer.

* * * * *
     (b) Classification. Class I (general controls). The device is 
exempt from the

[[Page 2323]]

premarket notification procedures in subpart E of part 807 of this 
chapter subject to Sec. 892.9.
     239. Section 892.1890 is amended by revising paragraph (b) to read 
as follows:


Sec. 892.1890  Radiographic film illuminator.

* * * * *
     (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. 892.9.
     240. Section 892.1910 is amended by revising paragraph (b) to read 
as follows:


Sec. 892.1910  Radiographic grid.

* * * * *
     (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. 892.9.
     241. Section 892.1960 is amended by revising paragraph (b) to read 
as follows:


Sec. 892.1960  Radiographic intensifying screen.

* * * * *
     (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. 892.9.
     242. Section 892.1970 is amended by revising paragraph (b) to read 
as follows:


Sec. 892.1970  Radiographic ECG/respirator synchronizer.

* * * * *
     (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. 892.9.
     243. Section 892.2010 is amended by revising paragraph (b) to read 
as follows:


Sec. 892.2010  Medical image storage device.

* * * * *
     (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. 892.9.
     244. Section 892.2020 is amended by revising paragraph (b) to read 
as follows:


Sec. 892.2020  Medical image communications device.

* * * * *
     (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. 892.9.
     245. Section 892.5650 is amended by revising paragraph (b) to read 
as follows:

Sec. 892.5650  Manual radionuclide applicator system.

* * * * *
     (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. 892.9.
     246. Section 892.6500 is amended by revising paragraph (b) to read 
as follows:


Sec. 892.6500  Personnel protective shield.

* * * * *
     (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. 892.9.

    Dated: December 22, 1999.
Linda S. Kahan,
Deputy Director for Regulations Policy, Center for Devices and 
Radiological Health.
[FR Doc. 00-884 Filed 1-13-00; 8:45 am]
BILLING CODE 4160-01-F