[Federal Register Volume 68, Number 81 (Monday, April 28, 2003)]
[Notices]
[Pages 22391-22400]
From the Federal Register Online via the Government Printing 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: standards@cdrh.fda.gov. 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