[Federal Register Volume 68, Number 81 (Monday, April 28, 2003)]
[Notices]
[Pages 22391-22400]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 03-10417]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 03N-0077]
FDA Modernization Act of 1997: Modifications to the List of
Recognized Standards, Recognition List Number: 008
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is announcing a
publication containing modifications the agency is making to the list
of standards FDA recognizes for use in premarket reviews (FDA
Recognized Consensus Standards). This publication entitled
``Modifications to the List of Recognized Standards, Recognition List
Number: 008'' (Recognition List Number: 008) will assist manufacturers
who elect to declare conformity with consensus standards to meet
certain requirements for medical devices.
DATES: Submit written or electronic comments concerning this document
at any time. See section VII of this document for the effective date of
the recognition of standards announced in this document.
ADDRESSES: Submit written requests for single copies on a 3.5''
diskette of ``Modification to the List of Recognized Standards,
Recognition List Number: 008'' to the Division of Small Manufacturers
Assistance (DSMA), Center for Devices and Radiological Health (CDRH)
(HFZ-220), Food and Drug Administration, 1350 Piccard Dr., Rockville,
MD 20850. Send two self-addressed adhesive labels to assist that office
in processing your requests, or fax your request to 301-443-8818.
Submit written comments concerning this document or to recommend
additional standards for recognition to the contact person (see FOR
FURTHER INFORMATION CONTACT). Comments should be identified with the
docket number found in brackets in the heading of this document. Submit
electronic comments by e-mail: [email protected]. This document
may also be accessed on FDA's Internet site at http://www.fda.gov/cdrh/fedregin.html. See section VI of this document for electronic access to
the searchable database for the current list of ``FDA Recognized
Consensus Standards,'' including Recognition List Number: 008
modifications and other standards related information.
FOR FURTHER INFORMATION CONTACT: Carol L. Herman, Center for Devices
and
[[Page 22392]]
Radiological Health (HFZ-84), Food and Drug Administration, 2094
Gaither Rd., Rockville, MD 20850, 301-594-4766, ext. 156.
SUPPLEMENTARY INFORMATION:
I. Background
Section 204 of the Food and Drug Administration Modernization Act
of 1997 (FDAMA) (Public Law 105-115) amended section 514 of the Federal
Food, Drug, and Cosmetic Act (the act) (21 U.S.C. 360d). Amended
section 514 allows FDA to recognize consensus standards, developed by
international and national organizations, for use in satisfying
portions of device premarket review submissions or other requirements.
In a notice published in the Federal Register of February 25, 1998
(63 FR 9561), FDA announced the availability of guidance entitled
``Recognition and Use of Consensus Standards.'' This notice described
how FDA will implement its standard recognition program and provided
the initial list of recognized standards.
In Federal Register notices published on October 16, 1998 (63 FR
55617); July 12, 1999 (64 FR 37546); November 15, 2000 (65 FR 69022);
May 7, 2001 (66 FR 23032), January 14, 2002 (67 FR 1774), and October
2, 2002 (67 FR 61893), FDA modified its initial list of recognized
standards. These notices described the addition, withdrawal, and
revision of certain standards recognized by FDA.
The agency maintains ``html'' and ``pdf'' versions of the list of
``FDA Recognized Consensus Standards.'' Both versions are publicly
accessible at the agency's Internet site. See section VI of this
document for electronic access information.
II. Modifications to the List of Recognized Standards, Recognition List
Number: 008
FDA is announcing the addition, withdrawal, correction, and
revision of certain consensus standards the agency will recognize for
use in satisfying premarket reviews and other requirements for devices.
FDA will incorporate these modifications in the list of ``FDA
Recognized Consensus Standards'' in the agency's searchable database.
FDA will use the term ``Recognition List Number: 008'' to identify: (1)
Supplementary information sheets for standards added to the list for
the first time, (2) standards added to replace withdrawn standards, (3)
recognized standards for which minor revisions are made to clarify the
application of the standards, and (4) standards withdrawn with no
replacement.
In the following charts, FDA describes: (1) Modifications that
involve the withdrawal of standards and their replacement by others,
(2) the correction of errors made by FDA in listing previously
recognized standards, and (3) the addition of certain recognized
standards with revisions to the supplementary information sheets
involving changes in significant applications of the standards.
In section III, FDA lists modifications the agency is making that
involve the initial addition of standards not previously recognized by
FDA.
A. Anesthesia
------------------------------------------------------------------------
Replacement
Old Item No. Standard Change Item No.
------------------------------------------------------------------------
12 ISO 5361:1999 Withdrawn and 35
Anaesthetic and replaced with
respiratory newer
equipment--Tracheal version.
tubes and
connectors.
------------------------------------------------------------------------
13 ISO 5361-2:1993 Withdrawn and (35)
Tracheal Tubes--Part integrated
2: Oro-tracheal and into another
Naso-tracheal tubes standard.
of Magill Type
(plain and cuffed).
------------------------------------------------------------------------
14 ISO 5361-3:1984 Withdrawn and (35)
Tracheal Tubes--Part integrated
3: Murphy Type. into another
standard.
------------------------------------------------------------------------
16 ISO 5361-5:1984 Withdrawn and (35)
Tracheal Tubes--Part integrated
5: Requirements and into another
Methods of Test for standard.
Cuffs and Tubes.
------------------------------------------------------------------------
17 ISO 5366-3:2001 Withdrawn and 36
Anaesthetic and replaced with
respiratory newer
equipment--Tracheost version.
omy tubes--Part 3:
Paediatric
tracheostomy tubes.
------------------------------------------------------------------------
26 CGA C-9:1988 Edition: Withdrawn and 37
3 Title: Standard replaced with
Color Marking of newer
Compressed Gas version.
Containers Intended
for Medical Use.
------------------------------------------------------------------------
27 CGA V-1:2001 Edition: Withdrawn and 38
9 Title: Compressed replaced with
Gas Association newer
Standard for version.
Compressed Gas
Cylinder Valve
Outlet and Inlet
Connections.
------------------------------------------------------------------------
28 CGA V-5:2000 Edition: Withdrawn and 39
4 Title: Diameter replaced with
Index Safety System newer
(Noninterchangeable version.
Low Pressure
Connections for
Medical Gas
Applications).
------------------------------------------------------------------------
29 CGA V-7.1: 1997 Withdrawn and 40
Edition: 1 Title: replaced with
Standard Method of newer
Determining Cylinder version.
Valve Outlet
Connections for
Medical Gases.
------------------------------------------------------------------------
22 NFPA 99 Standard for Withdrawn and 41
Health Care replaced with
Facilities CHAPTER newer
19--Hyperbaric version.
Facilities.
------------------------------------------------------------------------
[[Page 22393]]
B. Biocompatibility
------------------------------------------------------------------------
Replacement
Old Item No. Standard Change Item No.
------------------------------------------------------------------------
7 ASTM F719-81(2002)e1, Withdrawn and 68
Standard Practice replaced with
for Testing newer
Biomaterials in version.
Rabbits for Primary
Skin Irritation.
------------------------------------------------------------------------
30 ASTM F720-81(2002)e1, Withdrawn and 69
Standard Practice replaced with
for Testing Guinea newer
Pigs for Contact version.
Allergens: Guinea
Pig Maximization
Test.
------------------------------------------------------------------------
32 ASTM F750-87(2002)e1, Withdrawn and 70
Standard Practice replaced with
for Evaluating newer
Material Extracts by version.
Systemic Injection
in the Mouse.
------------------------------------------------------------------------
C. Cardiovascular/Neurology
------------------------------------------------------------------------
Replacement
Old Item No. Standard Change Item No.
------------------------------------------------------------------------
46 ASTM F2079-02 Recognize 49
Standard Test newer year
Methods for date version.
Measuring Recoil of
Balloon-Expandable
Stents.
------------------------------------------------------------------------
D. Dental/ENT
------------------------------------------------------------------------
Replacement
Old Item No. Standard Change Item No.
------------------------------------------------------------------------
48 ANSI/ADA Correction in .............
Specification No. title (dash
16:1989, Dental between oxide
Impression Paste and eugenol).
Zinc Oxide--Eugenol
Type.
------------------------------------------------------------------------
64 ISO 3107:1988, Dental Correction in .............
Zinc Oxide/Eugenol title (slash
Cements and Zinc between oxide
Oxide Non-Eugenol and eugenol).
Cements.
------------------------------------------------------------------------
66 ISO 4049:1988, Correction in .............
Dentistry-Resin-- year date
Based Filling (1988 instead
Materials. of 1998).
------------------------------------------------------------------------
86 ANSI/ADA Correction in .............
Specification No. title (change
38:2000, Metal- to systems).
Ceramic Systems.
------------------------------------------------------------------------
E. General
------------------------------------------------------------------------
Replacement
Old Item No. Standard Change Item No.
------------------------------------------------------------------------
6 IEC 60601-1-2, (First Re-recognize 6
Edition, 1993-04),
Medical Electrical
Equipment--Part 1:
General Requirements
for Safety;
Electromagnetic
Compatibility--Requi
rements and Tests.
------------------------------------------------------------------------
28 IEC 60601-1-2, Extension of 28
(Second Edition), time period
Medical Electrical for the
Equipment--Part 1: transition
General Requirements statement.
for Safety;
Electromagnetic
Compatibility -
Requirements and
Tests.
------------------------------------------------------------------------
H. General Hospital/ General Plastic Surgery
------------------------------------------------------------------------
Replacement
Old Item No. Standard Change Item No.
------------------------------------------------------------------------
81 ASTM E1061 Title 81
correction
------------------------------------------------------------------------
[[Page 22394]]
I. In Vitro Devices
------------------------------------------------------------------------
Replacement
Old Item No. Standard Change Item No.
------------------------------------------------------------------------
30 NCCLS H15-A3, Revision 71
Reference and
Selected Procedures
for the Quantitative
Determination of
Hemoglobin in Blood;
Approved Standard--
Third Edition.
------------------------------------------------------------------------
45 NCCLS M11-A5, Methods Revision 75
for Antimicrobial
Susceptibility
Testing of Anaerobic
Bacteria; Approved
Standard--Fifth
Edition.
------------------------------------------------------------------------
10 NCCLS M23-A2, Revision 78
Development of In
Vitro Susceptibility
Testing Criteria and
Quality Control
Parameters; Approved
Guideline--Second
Edition.
------------------------------------------------------------------------
1 NCCLS C28-A2, How to Revision 81
Define and Determine
Reference Intervals
in the Clinical
Laboratory; Approved
Guideline--Second
Edition.
------------------------------------------------------------------------
20 NCCLS C34-A2, Sweat Revision 82
Testing: Collection
and Quantitative
Analysis; Approved
Guideline--Second
Edition.
------------------------------------------------------------------------
5 NCCLS H18-A2, Withdraw 57
Procedures for the
Handling and
Processing of Blood
Specimens; Approved
Guideline.
------------------------------------------------------------------------
8 NCCLS M2-A7, Withdraw 55
Performance
Standards for
Antimicrobial Disk
Susceptibility
Tests--Sixth
Edition; Approved
Standard.
------------------------------------------------------------------------
28 NCCLS H11-A3, Withdraw 58
Procedure for the
Collection of
Arterial Blood
Specimens; Approved
Standard.
------------------------------------------------------------------------
44 NCCLS M7-A5, Methods Withdraw 56
for Dilution
Antimicrobial
Susceptibility Tests
for Bacteria Tests
for Bacteria That
Grow Aerobically--
Fourth Edition;
Approved Standard.
------------------------------------------------------------------------
J. Materials
------------------------------------------------------------------------
Replacement
Old Item No. Standard Change Item No.
------------------------------------------------------------------------
1 ASTM F67-00, Standard Clarification .............
Specification for to extent of
Unalloyed Titanium recognition
for Surgical Implant with regard
Applications (UNS to
R50250, UNS R50400, biocompatibil
UNS R50550, UNS ity
R50700). requirements.
------------------------------------------------------------------------
2 ASTM F75-01, Standard Cardiovascular .............
Specification for contact
Cobalt-28 Chromium-6 person.
Molybdenum Alloy Clarification
Castings and Casting to extent of
Alloy for Surgical recognition
Implants (UNS with regard
R30075). to
biocompatibil
ity
requirements.
------------------------------------------------------------------------
3 ASTM F90-01, Standard Cardiovascular .............
Specification for contact
Wrought Cobalt-20 person.
Chromium-15 Tungsten- Clarification
10 Nickel Alloy for to extent of
Surgical Implant recognition
Applications (UNS with regard
R30605). to
biocompatibil
ity
requirements.
------------------------------------------------------------------------
4 ASTM F136-02, Withdrawn and 44
Standard replaced with
Specification for newer
Wrought Titanium-6 version.
Aluminum-4 Vanadium Cardiovascula
ELI (Extra Low r contact
Interstitial) Alloy person.
for Surgical Implant Clarification
Applications (UNS to extent of
R56401). recognition
with regard
to
biocompatibil
ity
requirements.
------------------------------------------------------------------------
[[Page 22395]]
5 ASTM F138-00, Cardiovascular .............
Standard contact
Specification for person.
Wrought 18 Chromium- Clarification
14 Nickel-2.5 to extent of
Molybdenum Stainless recognition
Steel Bar and Wire with regard
for Surgical to
Implants (UNS biocompatibil
S31673). ity
requirements.
------------------------------------------------------------------------
6 ASTM F139-00, Clarification .............
Standard to extent of
Specification for recognition
Wrought 18 Chromium- with regard
14 Nickel-2.5 to
Molybdenum Stainless biocompatibil
Steel Sheet and ity
Strip for Surgical requirements.
Implants (UNS
S31673).
------------------------------------------------------------------------
7 ASTM F560-98, Cardiovascular .............
Standard contact
Specification for person.
Unalloyed Tantalum Clarification
for Surgical Implant to extent of
Applications (UNS recognition
R05200, UNS R05400). with regard
to
biocompatibil
ity
requirements.
------------------------------------------------------------------------
8 ASTM F562-02, Withdrawn and 45
Standard replaced with
Specification for newer
Wrought 35 Cobalt-35 version.
Nickel-20 Chromium- Cardiovascula
10 Molybdenum Alloy r contact
for Surgical Implant person.
Applications (UNS Clarification
R30035). to extent of
recognition
with regard
to
biocompatibil
ity
requirements.
------------------------------------------------------------------------
9 ASTM F563-00, Cardiovascular .............
Standard contact
Specification for person.
Wrought Cobalt-20 Clarification
Nickel-20 Chromium- to extent of
3.5 Molybdenum-3.5 recognition
Tungsten-5 Iron with regard
Alloy for Surgical to
Implant Applications biocompatibil
(UNS R30563). ity
requirements.
------------------------------------------------------------------------
10 ASTM F603-00, Clarification .............
Standard to extent of
Specification for recognition
High-Purity Dense with regard
Aluminum Oxide for to
Surgical Implant biocompatibil
Application. ity
requirements.
------------------------------------------------------------------------
11 ASTM F620-00, Clarification .............
Standard to extent of
Specification for recognition
Alpha Plus Beta with regard
Titanium Alloy to
Forgings for biocompatibil
Surgical Implants. ity
requirements.
------------------------------------------------------------------------
12 ASTM F621-02, Withdrawn and 46
Standard replaced with
Specification for newer
Stainless Steel version.
Forgings for Clarification
Surgical Implants. to extent of
recognition
with regard
to
biocompatibil
ity
requirements.
------------------------------------------------------------------------
13 ASTM F648-00, Clarification .............
Standard to extent of
Specification for recognition
Ultra-High-Molecular- with regard
Weight Polyethylene to
Powder and biocompatibil
Fabricated Form for ity
Surgical Implants. requirements.
------------------------------------------------------------------------
14 ASTM F688-00, Clarification .............
Standard to extent of
Specification for recognition
Wrought Cobalt-35 with regard
Nickel-20 Chromium- to
10 Molybdenum Alloy biocompatibil
Plate, Sheet, and ity
Foil for Surgical requirements.
Implants (UNS
R30035).
------------------------------------------------------------------------
15 ASTM F745-00, Clarification .............
Standard to extent of
Specification for 18 recognition
Chromium-12.5 Nickel- with regard
2.5 Molybdenum to
Stainless Steel for biocompatibil
Cast and Solution- ity
Annealed Surgical requirements.
Implant
Applications.
------------------------------------------------------------------------
17 ASTM F799-02, Withdrawn and 47
Standard replaced with
Specification for newer
Cobalt-28 Chromium-6 version.
Molybdenum Alloy Clarification
Forgings for to extent of
Surgical Implants recognition
(UNS R31537, R31538, with regard
R31539). to
biocompatibil
ity
requirements.
------------------------------------------------------------------------
18 ASTM F899-02, Withdrawn and 48
Standard replaced with
Specification for newer
Stainless Steel for version.
Surgical Clarification
Instruments. to extent of
recognition
with regard
to
biocompatibil
ity
requirements.
------------------------------------------------------------------------
[[Page 22396]]
19 ASTM F961-96, Cardiovascular .............
Standard contact
Specification for person.
Cobalt-35 Nickel-20 Clarification
Chromium-10 to extent of
Molybdenum Alloy recognition
Forgings for with regard
Surgical Implants to
(UNS R30035). biocompatibil
ity
requirements.
------------------------------------------------------------------------
20 ASTM F1058-02, Withdrawn and 49
Standard replaced with
Specification for newer
Wrought 40 Cobalt-20 version.
Chromium-16 Iron-15 Cardiovascula
Nickel-7 Molybdenum r contact
Alloy Wire and Strip person
for Surgical Implant change.
Applications (UNS Clarification
R30003 and UNS to extent of
R30008). recognition
with regard
to
biocompatibil
ity
requirements.
------------------------------------------------------------------------
21 ASTM F1088- Clarification .............
87(1992)e1, Standard to extent of
Specification for recognition
Beta-Tricalcium with regard
Phosphate for to
Surgical biocompatibil
Implantation. ity
requirements.
------------------------------------------------------------------------
22 ASTM F1091-02, Withdrawn and 50
Standard replaced with
Specification for newer
Wrought Cobalt-20 version.
Chromium-15 Tungsten- Clarification
10 Nickel Alloy to extent of
Surgical Fixation recognition
Wire (UNS R30605). with regard
to
biocompatibil
ity
requirements.
------------------------------------------------------------------------
23 ASTM F1108-02, Withdrawn and 51
Standard replaced with
Specification for newer
Titanium-6 Aluminum- version.
4 Vanadium Alloy Clarification
Castings for to extent of
Surgical Implants recognition
(UNS R56406). with regard
to
biocompatibil
ity
requirements.
------------------------------------------------------------------------
24 ASTM F1185-88 Discontinued Withdrawn
(1993)e1, Standard by ASTM in
Specification for 2002, no
Composition of replacement.
Ceramic
Hydroxylapatite for
Surgical Implants.
------------------------------------------------------------------------
25 ASTM F1295-01, Clarification .............
Standard to extent of
Specification for recognition
Wrought Titanium-6 with regard
Aluminum-7 Niobium to
Alloy for Surgical biocompatibil
Implant Applications ity
(UNS R56700). requirements.
------------------------------------------------------------------------
26 ASTM F1314-01, Clarification .............
Standard to extent of
Specification for recognition
Wrought Nitrogen with regard
Strengthened 22 to
Chromium-13 Nickel-5 biocompatibil
Manganese-2.5 ity
Molybdenum Stainless requirements.
Steel Alloy Bar and
Wire for Surgical
Implants (UNS
S20910).
------------------------------------------------------------------------
27 ASTM F1341-99, Clarification .............
Standard to Extent of
Specification for Recognition
Unalloyed Titanium with regard
Wire UNS R50250, UNS to
R50400, UNS R50550, biocompatibil
UNS R50700, for ity
Surgical Implant requirements.
Applications.
------------------------------------------------------------------------
28 ASTM F1350-02, Withdrawn and 52
Standard replaced with
Specification for newer
Wrought 18 Chromium- version.
14 Nickel-2.5 Clarification
Molybdenum Stainless to extent of
Steel Surgical recognition
Fixation Wire (UNS with regard
S31673). to
biocompatibil
ity
requirements.
------------------------------------------------------------------------
29 ASTM F1472-02, Withdrawn and 53
Standard replaced with
Specification for newer
Wrought Titanium-6 version.
Aluminum-4 Vanadium Clarification
Alloy for Surgical to extent of
Implant Applications recognition
(UNS R56400). with regard
to
biocompatibil
ity
requirements.
------------------------------------------------------------------------
30 ASTM F1537-00, Clarification .............
Standard to extent of
Specification for recognition
Wrought Cobalt-28- with regard
Chromium-6- to
Molybdenum Alloy for biocompatibil
Surgical Implants ity
(UNS R31537, UNS requirements.
R31538, and UNS
R31539).
------------------------------------------------------------------------
31 ASTM F1580-01, Withdrawn and 54
Standard replaced with
Specification for newer
Titanium and version.
Titanium-6 Aluminum- Clarification
4 Vanadium Alloy to extent of
Powders for Coatings recognition
of Surgical with regard
Implants. to
biocompatibil
ity
requirements.
------------------------------------------------------------------------
[[Page 22397]]
32 ASTM F1586-02, Clarification .............
Standard to extent of
Specification for recognition
Wrought Nitrogen with regard
Strengthened 21 to
Chromium-10 Nickel-3 biocompatibil
Manganese-2.5 ity
Molybdenum Stainless requirements.
Steel Bar for
Surgical Implants
(UNS S31675).
------------------------------------------------------------------------
33 ASTM F1609-95, Clarification .............
Standard to extent of
Specification for recognition
Calcium Phosphate with regard
Coatings for to
Implantable biocompatibil
Materials. ity
requirements.
------------------------------------------------------------------------
K. Orthopedic
------------------------------------------------------------------------
Replacement
Old Item No. Standard Change Item No.
------------------------------------------------------------------------
57 ASTM F1717-01 Withdrawn and 159
Standard Test replaced with
Methods for Spinal newer
Implant Constructs version.
in a Vertebrectomy
Model.
------------------------------------------------------------------------
98 ASTM F629-02 Standard Withdrawn and 160
Practice for replaced with
Radiography of Cast newer
Metallic Surgical version.
Implants.
------------------------------------------------------------------------
153 ASTM F1264-01 Withdrawn and 161
Standard replaced with
Specification and newer
Test Methods for version.
Intramedullary
Fixation Devices.
------------------------------------------------------------------------
156 ASTM F564-02 Standard Withdrawn and 162
Specification and replaced with
Test Methods for newer
Metallic Bone version.
Staples.
------------------------------------------------------------------------
157 ASTM F543-02 Standard Withdrawn and 163
Specification and replaced with
Test Methods for newer
Metallic Medical version.
Bone Screws.
------------------------------------------------------------------------
158 ASTM F1541-02 Withdrawn and 164
Standard replaced with
Specification and newer
Test Methods for version.
External Skeletal
Fixation Devices.
------------------------------------------------------------------------
L. Sterility
------------------------------------------------------------------------
Replacement
Old Item No. Standard Change Item No.
------------------------------------------------------------------------
71 ANSI/AAMI ST8:2001, Change in .............
Hospital Steam Title
Sterilizers (Sterilizers
instead of
Sterilization
).
------------------------------------------------------------------------
77 ANSI/AAMI ST24:1999, Change in .............
Automatic General title (add
Purpose Ethylene third
Oxide Sterilizers edition)
and Ethylene Oxide
Sterilant Sources
Intended for Use in
Health Care
Facilities, 3rd.
Edition.
------------------------------------------------------------------------
91 ASTM F2096-02, Recognize .............
Standard Test Method newer year
for Detecting Gross version
Leaks in Porous (Should be 02
Medical Packaging by instead of
Internal 01).
Pressurization
(Bubble Test).
------------------------------------------------------------------------
IV. Listing of New Entries
The listing of new entries and consensus standards added as
``Modifications to the List of Recognized Standards,'' under
Recognition List Number: 008, is as follows:
A. Anesthesia
------------------------------------------------------------------------
Reference No. and
Item No. Title of Standard Date
------------------------------------------------------------------------
42 Anaesthetic vaporizers-- ISO 5360:1993
Agent-specific filling
systems
------------------------------------------------------------------------
43 Anaesthetic reservoir bags ISO 5362:2000
------------------------------------------------------------------------
[[Page 22398]]
44 Anaesthetic and ISO 5366-1:2000
respiratory equipment--
Tracheostomy tubes--Part
1: Tubes and connectors
for use in adults.
------------------------------------------------------------------------
B. General
------------------------------------------------------------------------
Reference No. and
Item No. Title of Standard Date
------------------------------------------------------------------------
30 Medical Electrical ANSI/AAMI/IEC 60601-1-
Equipment--Part 1-2: 2:2001
General Requirements for
Safety - Collateral
Standard: Electromagnetic
Compatibility--Requiremen
ts and Tests.
------------------------------------------------------------------------
C. In Vitro Devices
------------------------------------------------------------------------
Reference No. and
Item No. Title of Standard Date
------------------------------------------------------------------------
65 Evaluation of Precision NCCLS EP5-A:1999
Performance of Clinical
Chemistry Devices;
Approved Guideline.
------------------------------------------------------------------------
66 Preliminary Evaluation of NCCLS EP10-A:1998
Quantitative Clinical
Laboratory Methods;
Approved Guideline.
------------------------------------------------------------------------
67 Evaluation of Matrix NCCLS EP14-A:2001
Effects; Approved
Guideline
------------------------------------------------------------------------
68 Laboratory Instruments and NCCLS GP19-A2:2001
Data Management Systems:
Design of Software User
Interfaces and End-User
Software Systems
Validation, Operation,
and Monitoring; Approved
Guideline--Second
Edition.
------------------------------------------------------------------------
69 Procedures for the NCCLS H3-A4:1998
Collection of Diagnostic
Blood Specimens by
Venipuncture; Approved
Standard--Fourth Edition.
------------------------------------------------------------------------
70 Procedures and Devices for NCCLS H4-A4:1999
the Collection of
Diagnostic Blood
Specimens by Skin
Puncture; Approved
Standard--Fourth Edition.
------------------------------------------------------------------------
72 Clinical Application of NCCLS H42-A:1998
Flow Cytometry: Quality
Assurance
Immunophenotyping of
Lymphocytes; Approved
Guideline.
------------------------------------------------------------------------
73 Clinical Evaluation of NCCLS I/LA21-A:2002
Immunoassays; Approved
Guideline
------------------------------------------------------------------------
74 Protocols for Evaluating NCCLS M6-A:1996
Dehydrated Mueller-Hinton
Agar; Approved Standard.
------------------------------------------------------------------------
76 Laboratory Diagnosis of NCCLS M15-A:2000
Blood-Borne Parasitic
Diseases; Approved
Guideline.
------------------------------------------------------------------------
77 Quality Assurance for NCCLS M22-A2:1996
Commerically Prepared
Microbiological Culture
Media--Second Edition;
Approved Standard.
------------------------------------------------------------------------
79 Procedures for the NCCLS M28-A:1997
Recovery and
Identification of
Parasites from the
Intestinal Tract;
Approved Guideline.
------------------------------------------------------------------------
80 Molecular Diagnostic NCCLS MM1-A:2000
Methods for Genetic
Diseases; Approved
Guideline.
------------------------------------------------------------------------
83 Blood Gas and pH Analysis NCCLS C46-A:2001
and Related Measurements;
Approved Guideline.
------------------------------------------------------------------------
84 Stability Testing of In EN 13640:2001
Vitro Diagnostic Reagents
------------------------------------------------------------------------
C. Materials
[[Page 22399]]
------------------------------------------------------------------------
Reference No. and
Item No. Title of Standard Date
------------------------------------------------------------------------
30 Medical Electrical ANSI/AAMI/IEC 60601-1-
Equipment--Part 1-2: 2:2001
General Requirements for
Safety--Collateral
Standard: Electromagnetic
Compatibility--Requiremen
ts and Tests.
------------------------------------------------------------------------
31 Symbols to be used with ISO 15223:2000
medical device labels,
labeling and information
to be supplied.
------------------------------------------------------------------------
32 Graphical symbols for use EN
in the labeling of 980:1996+A1:1999+A2:
medical devices. 2001
------------------------------------------------------------------------
55 Standard Test Method for ASTM F2182-02
Measurement of Radio
Frequency Induced Heating
Near Passive Implants
During Magnetic Resonance
Imaging.
------------------------------------------------------------------------
D. Tissue Engineering
------------------------------------------------------------------------
Reference No. and
Item No. Title of Standard Date
------------------------------------------------------------------------
1 Standard Guide for ASTM F2064:2000
Characterization and
Testing of Alginates as
Starting Materials
Intended for Use in
Biomedical and Tissue-
Engineered Medical
Products Application.
------------------------------------------------------------------------
2 Standard Guide for ASTM F2103:2001
Characterization and
Testing of Chitosan Salts
as Starting Materials
Intended for Use in
Biomedical and Tissue-
Engineered Medical
Product Applications.
------------------------------------------------------------------------
IV. List of Recognized Standards
FDA maintains the agency's current list of ``FDA Recognized
Consensus Standards'' in a searchable database that may be accessed
directly at FDA's Internet site at http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfStandards/search.cfm. FDA will incorporate the
modifications and minor revisions described in this notice into the
database and, upon publication in the Federal Register, this
recognition of consensus standards will be effective. FDA will announce
additional modifications and minor revisions to the list of recognized
consensus standards, as needed, in the Federal Register once a year, or
more often, if necessary.
V. Recommendation of Standards for Recognition by FDA
Any person may recommend consensus standards as candidates for
recognition under the new provision of section 514 of the act by
submitting such recommendations, with reasons for the recommendation,
to the contact person (see FOR FURTHER INFORMATION CONTACT). To be
properly considered, such recommendations should contain, at a minimum,
the following information: (1) Title of the standard, (2) any reference
number and date, (3) name and address of the national or international
standards development organization, (4) a proposed list of devices for
which a declaration of conformity to this standard should routinely
apply, and (5) a brief identification of the testing or performance or
other characteristics of the device(s) that would be addressed by a
declaration of conformity.
VI. Electronic Access
In order to receive ``Guidance on the Recognition and Use of
Consensus Standards'' via your fax machine, call the CDRH Facts-On-
Demand system at 800-899-0381 or 301-827-0111 from a touch-tone
telephone. Press 1 to enter the system. At the second voice prompt
press 1 to order a document. Enter the document number 321 followed by
the pound sign (). Follow the remaining voice prompts to
complete your request.
You may obtain a copy of ``Guidance on the Recognition and Use of
Consensus Standards' by using the Internet. CDRH maintains a site on
the Internet for easy access to information including text, graphics,
and files that you may download to a personal computer with access to
the Internet. Updated on a regular basis, the CDRH home page includes
this guidance as well as the current list of recognized standards and
other standards related documents. After publication in the Federal
Register, this notice announcing ``Modifications to the List of
Recognized Standards, Recognition List Number: 008'' will be available
on the CDRH home page. You may access the CDRH home page at http://www.fda.gov/cdrh. You may access ``Guidance on the Recognition and Use
of Consensus Standards,'' and the searchable data base for ``FDA
Recognized Consensus Standards,'' through hyperlinks at http://www.fda.gov/cdrh/stdsprog.html. This Federal Register notice of
modifications in FDA's recognition of consensus standards will be
available, upon publication, at http://www.fda.gov/cdrh/fedregin.html.
VII. Submission of Comments and Effective Date
Interested persons may submit to the contact person (see FOR
FURTHER INFORMATION CONTACT) written or electronic comments regarding
this document. Two copies of any mailed comments are to be submitted,
except that individuals may submit one copy. Identify comments with the
docket number found in brackets in the heading of this document. FDA
will consider any comments received in determining whether to amend the
current listing of ``Modifications to the List of Recognized Standards,
Recognition List Number: 008.'' These modifications to the list of
recognized standards are effective upon publication of this notice.
[[Page 22400]]
Dated: April 7, 2003.
Linda S. Kahan,
Deputy Director, Center for Devices and Radiological Health.
[FR Doc. 03-10417 Filed 4-25-03; 8:45 am]
BILLING CODE 4160-01-S