[Federal Register Volume 67, Number 191 (Wednesday, October 2, 2002)]
[Notices]
[Pages 61893-61910]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 02-24954]


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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 97D-0530]


FDA Modernization Act of 1997: Modifications to the List of 
Recognized Standards, Recognition List Number: 007

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 will recognize for use in premarket reviews (FDA 
Recognized Consensus Standards). This publication, entitled 
``Modifications to the List of Recognized Standards, Recognition List 
Number: 007'' (recognition list number: 007), will assist manufacturers 
who elect to declare conformity with consensus standards to meet 
certain requirements for medical devices.

DATES: The recognition of standards announced in this document will 
become effective October 2, 2002. Submit written comments concerning 
this document at any time.

ADDRESSES: Submit written requests for single copies on a 3.5'' 
diskette of ``Modifications to the List of Recognized Standards, 
Recognition List Number: 007'' 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 to the contact person 
(see FOR FURTHER INFORMATION CONTACT). Identify comments with the 
docket number found in brackets in the heading of this document. You 
may access this document on FDA's Internet site at http://www.fda.gov/
cdrh/fedregin.html. See section V of this document for electronic 
access to the searchable database for the current list of ``FDA 
Recognized Consensus Standards,'' including recognition list number: 
007 modifications, and other standards related information.

FOR FURTHER INFORMATION CONTACT: Carol L. Herman, Center for Devices 
and 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 of the act 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 standards program recognizing the use of 
certain standards 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), and January 14, 2002 (67 FR 1774), FDA 
modified its initial list of recognized standards. These notices 
described the addition, withdrawal, and revision of certain standards 
recognized by FDA.
    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 this recognition of consensus standards will be effective 
upon publication in the Federal Register. 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.
    For each of the recognized standards, FDA provides in the database 
a supplementary information sheet that includes information such as:
    1. Devices affected by the standard;
    2. Processes affected by the standard (premarket notification 
(510(k), premarket approval (PMA), investigational device exemption 
(IDE), product development protocol (PDP), and quality systems 
regulation (QSR));
    3. Extent of recognition (all or part of the standard, for what 
purpose the standard is recognized);
    4. Related citations in the Code of Federal Regulations that 
identify the devices covered;
    5. Related product codes that are used by FDA to identify the 
devices covered; and
    6. Guidances relevant to the devices affected by the standard.

II. Modifications to the List of Recognized Standards, Recognition List 
Number: 007

    FDA is announcing the addition, withdrawal, correction, and 
revision of certain consensus standards the agency

[[Page 61894]]

will recognize for use in satisfying portions of premarket review 
submissions for devices. FDA will incorporate these modifications in 
the list of ``FDA Recognized Consensus Standards'' in the agency's 
searchable database. FDA is also establishing two new categories of 
recognized standards: (1) ``Materials'' and (2) ``tissue engineering'' 
standards. The tables below reflect the changes FDA is making to the 
list of recognized standards. These changes include:
    [sbull] Withdrawn and replaced with a newer version
    [sbull] Withdrawn and transferred to materials
    [sbull] Contact person
    [sbull] Transition statement added to the extend of recognition
    [sbull] Citations and product codes
    [sbull] Withdrawn
    [sbull] Title correction
    [sbull] Product codes and relevant guidance
    [sbull] Devices affected
    [sbull] Devices affected and type of standard
    The following tables are divided by standards categories, include 
the two new categories of materials and tissue engineering standards, 
and identify the old item number, the name of the standard, the 
specific change, and the new replacement number, if any.

A. Biocompatibility

------------------------------------------------------------------------
                                                            Replacement
   Old Item No.            Standard            Change         Item No.
------------------------------------------------------------------------
12                   ASTM F813-01,         Withdrawn and
                     Standard Practice      replaced with
                     for Direct Contact     newer version
                     Cell Culture           56
                     Evaluation of
                     Materials for
                     Medical Devices
------------------------------------------------------------------------
13                  ASTM E895-84           Withdrawn and   57
                     (2001)e1, Standard     replaced with
                     Test Method for Agar   newer version
                     Diffusion Cell
                     Culture Screening
                     for Cytotoxicity
------------------------------------------------------------------------
46                  USP 25--NF20,          Withdrawn and   58
                     Biological Tests       replaced with
                     <87,        newer version
                     Biological
                     Reactivity Test, In
                     Vitro--Direct
                     Contact Test
------------------------------------------------------------------------
47                  USP 25--NF20,          Withdrawn and   59
                     Biological Tests       replaced with
                     <88,        newer version
                     Biological
                     Reactivity Test, In
                     Vitro--Elution Test
------------------------------------------------------------------------
48                  USP 25--NF20,          Withdrawn and   60
                     Biological Tests       replaced with
                     <88,        newer version
                     Biological
                     Reactivity Test, In
                     Vivo, Classification
                     of Plastics--Simple
                     Preparation
------------------------------------------------------------------------
49                  USP 25--NF20,          Withdrawn and   61
                     Biological Tests       replaced with
                     <88,        newer version
                     Biological
                     Reactivity Test, In
                     Vivo--Intracutaneous
                     Test
------------------------------------------------------------------------
50                  USP 25--NF20,          Withdrawn and   62
                     Biological Tests       replaced with
                     <88,        newer version
                     Biological
                     Reactivity Test, In
                     Vivo--Systemic
                     Injection Test
------------------------------------------------------------------------
55                  ANSI/AAMI/ISO 10993-   Withdrawn and   63
                     6:1995/(R)2001:        replaced with
                     Biological             newer version
                     evaluation of
                     medical devices--
                     Part 6: Test for
                     local effects after
                     implantation
------------------------------------------------------------------------
54                  ANSI/AAMI/ISO 10993-   Withdrawn and   64
                     5: Biological          replaced with
                     evaluation of          change in
                     medical devices--      extent of
                     Part 5: Tests for in   recognition
                     vitro cytotoxicity
------------------------------------------------------------------------

B. Cardiovascular/Neurology

------------------------------------------------------------------------
                                                             Replacement
   Old Item No.            Standard            Change         Item No.
------------------------------------------------------------------------
12                  ASTM F961-96,          Withdrawn and   .............
                     Standard               transferred
                     Specification for      to materials
                     Cobalt-35 Nickel-20
                     Chromium-10
                     Molybdenum Alloy
                     Forgings for
                     Surgical Implants
                     [UNS R30035]
------------------------------------------------------------------------
21                  ASTM F75-01, Standard  Withdrawn and   .............
                     Specification for      transferred
                     Cobalt-28 Chromium-6   to materials
                     Molybdenum Alloy
                     Castings and Casting
                     Alloy for Surgical
                     Implant (UNS R30075)
------------------------------------------------------------------------
22                  ASTM F90-01, Standard  Withdrawn and   .............
                     Specification for      transferred
                     Wrought Cobalt-20      to materials
                     Chromium-15 Tungsten-
                     10 Nickel Alloy for
                     Surgical Implant
                     Applications (UNS
                     R30605)
------------------------------------------------------------------------

[[Page 61895]]

 
24                  ASTM F560-98,          Withdrawn and   .............
                     Standard               transferred
                     Specification for      to materials
                     Unalloyed Tantalum
                     for Surgical Implant
                     Applications (UNS
                     R05200, UNS R05400)
------------------------------------------------------------------------
28                  ASTM F1058-97,         Withdrawn and   .............
                     Standard               transferred
                     Specification for      to materials
                     Wrought Cobalt-
                     Chromium-Nickel-
                     Molybdenum-Iron
                     Alloy for Surgical
                     Implant Applications
------------------------------------------------------------------------
34                  ASTM F138-00,          Withdrawn and   .............
                     Standard               transferred
                     Specification for      to materials
                     Wrought 18 Chromium-
                     14 Nickel-2.5
                     Molybdenum Stainless
                     Bar and Wire for
                     Surgical Implants
                     (UNS S31673)
------------------------------------------------------------------------
35                  ASTM F562-00,          Withdrawn and   .............
                     Standard               transferred
                     Specification for      to materials
                     Wrought Cobalt-35
                     Nickel-20 Chromium-
                     10 Molybdenum Alloy
                     for Surgical Implant
                     Applications
------------------------------------------------------------------------
36                  ASTM F136-98e1,        Withdrawn and   .............
                     Standard               transferred
                     Specification for      to materials
                     Wrought Titanium-6
                     Aluminum-4 Vanadium
                     ELI (Extra Low
                     Interstitial) Alloy
                     (UNS R56401) for
                     Surgical Implant
                     Applications
------------------------------------------------------------------------

C. Dental/ENT

------------------------------------------------------------------------
                                                             Replacement
  Old Item No.             Standard              Change       Item No.
------------------------------------------------------------------------
01                ASTM F67-00, Standard       Withdrawn     ............
                   Specification for           and
                   Unalloyed Titanium for      transferred
                   Surgical Implant            to
                   Applications (UNS R50250,   materials
                   UNS R50550, UNS R50700)
------------------------------------------------------------------------
02                ASTM F75-01, Standard       Withdrawn     ............
                   Specification for Cobalt-   and
                   28 Chromium-6 Molybdenum    transferred
                   Alloy Castings and          to
                   Casting Alloy for           materials
                   Surgical Implant (UNS R
                   30075)
------------------------------------------------------------------------
03                ASTM F90-01, Standard       Withdrawn     ............
                   Specification for Wrought   and
                   Cobalt-20 Chromium-15       transferred
                   Tungsten-10 Nickel Alloy    to
                   for Surgical Implant        materials
                   Applications (UNS R30605)
------------------------------------------------------------------------
04                ASTM F136-98e1, Standard     Withdrawn    ............
                   Specification for Wrought   and
                   Titanium-6 Aluminum-4       transferred
                   Vanadium ELI (Extra Low     to
                   Interstitial) Alloy (UNS    materials
                   R56401) for Surgical
                   Implant Applications
------------------------------------------------------------------------
05                ASTM F138-00, Standard      Withdrawn     ............
                   Specification for Wrought   and
                   18 Chromium-14 Nickel-2.5   transferred
                   Molybdenum Stainless Bar    to
                   and Wire for Surgical       materials
                   Implants (UNS S31673)
------------------------------------------------------------------------
06                ASTM F139-00, Standard      Withdrawn     ............
                   Specification for Wrought   and
                   18 Chromium-14 Nickel-2.5   transferred
                   Molybdenum Stainless        to
                   Steel Sheet and Strip for   materials
                   Surgical Implants (UNS
                   S31673)
------------------------------------------------------------------------
07                ASTM F562-00, Standard      Withdrawn     ............
                   Specification for Wrought   and
                   Cobalt-35 Nickel-20         transferred
                   Chromium-10 Molybdenum      to
                   Alloy for Surgical          materials
                   Implant Applications
------------------------------------------------------------------------
08                ASTM F620-00, Standard      Withdrawn     ............
                   Specification for Alpha     and
                   Beta Titanium Alloy         transferred
                   Forgings for Surgical       to
                   Implants                    materials
------------------------------------------------------------------------
09                ASTM F621-97, Standard      Withdrawn     ............
                   Specification for           and
                   Stainless Steel Forgings    transferred
                   for Surgical Implants       to
                                               materials
------------------------------------------------------------------------
10                ASTM F688-00, Standard      Withdrawn     ............
                   Specification for Wrought   and
                   Cobalt-35 Nickel-2.5        transferred
                   Molybdenum Alloy Plate,     to
                   Sheet, and Foil for         materials
                   Surgical Implants (UNS
                   R30035)
------------------------------------------------------------------------

[[Page 61896]]

 
11                ASTM F745-00, Standard      Withdrawn     ............
                   Specification for 18        and
                   Chromium-12.5 Nickel-2.5    transferred
                   Molybdenum Stainless        to
                   Steel for Cast and          materials
                   Solution-Annealed
                   Surgical Implant
                   Applications
------------------------------------------------------------------------
12                ASTM F799-99, Standard      Withdrawn     ............
                   Specification for Cobalt-   and
                   28 Chromium-6 Molybdenum    transferred
                   Alloy Forgings for          to
                   Surgical Implants (UNS      materials
                   R31537, R31538, R31539)
------------------------------------------------------------------------
13                ASTM F961-96, Standard      Withdrawn     ............
                   Specification for Cobalt-   and
                   35 Nickel-20 Chromium-10    transferred
                   Molybdenum Alloy Forgings   to
                   for Surgical Implants       materials
                   [UNS R30035]
------------------------------------------------------------------------
14                ASTM F1088-87 (1992)e1,     Withdrawn     ............
                   Standard Specification      and
                   for Beta-Tricalcium         transferred
                   Phosphate for Surgical      to
                   Implantation                materials
------------------------------------------------------------------------
15                ASTM F1091-91(2000),        Withdrawn     ............
                   Standard Specification      and
                   for Wrought Cobalt-20       transferred
                   Chromium-15 Tungsten-10     to
                   Nickel Alloy Surgical       materials
                   Fixation Wire (UNS R
                   30605)
------------------------------------------------------------------------
16                ASTM F1108-97a, Standard    Withdrawn     ............
                   Specification for Ti6A14V   and
                   Alloy Castings for          transferred
                   Surgical Implants (UNS      to
                   R56406)                     materials
------------------------------------------------------------------------
17                ASTM F1185-88(1993)e1,      Withdrawn     ............
                   Standard Specification      and
                   for Composition of          transferred
                   Ceramic Hydroxylapatite     to
                   for Surgical Implants       materials
------------------------------------------------------------------------
18                ASTM F1295-01, Standard     Withdrawn     ............
                   Specification for Wrought   and
                   Titanium-6 Aluminum-7       transferred
                   Niobium Alloy for           to
                   Surgical Implant            materials
                   Applications (UNS R56700)
------------------------------------------------------------------------
19                ASTM F1314-01, Standard     Withdrawn     ............
                   Specification for Wrought   and
                   Nitrogen Strengthened 22    transferred
                   Chromium-13 Nickel-5        to
                   Manganese-2.5 Molybdenum    materials
                   Stainless Steel Alloy Bar
                   and Wire for Surgical
                   Implants (UNS S20910)
------------------------------------------------------------------------
20                ASTM F1341-99, Standard     Withdrawn     ............
                   Specification for           and
                   Unalloyed Titanium Wire     transferred
                   UNS R50250, UNS R50400,     to
                   UNS R50500, UNS R50700,     materials
                   for Surgical Implant
                   Applications
------------------------------------------------------------------------
21                ASTM F1350-01, Standard     Withdrawn     ............
                   Specification for Wrought   and
                   18 Chromium-14 Nickel-      transferred
                   2.5, Molybdenum Stainless   to
                   Steel Surgical Fixation     materials
                   Wire (UNS S31673)
------------------------------------------------------------------------
23                ASTM F1472-00, Standard     Withdrawn     ............
                   Specification for Wrought   and
                   Titanium-6 Aluminum-4       transferred
                   Vanadium Alloy (UNS         to
                   R56400) for Surgical        materials
                   Implant Applications
------------------------------------------------------------------------
24                ASTM F1537-00, Standard     Withdrawn     ............
                   Specification for Wrought   and
                   Cobalt-28-Chromium-6-       transferred
                   Molybdenum Alloy for        to
                   Surgical Implants (UNS      materials
                   R31537, UNS R31538, and
                   UNS R31539)
------------------------------------------------------------------------
25                F1580-95e1, Standard        Withdrawn     ............
                   Specification for           and
                   Titanium and Titanium-6%    transferred
                   Aluminum-4% Vanadium        to
                   Alloy Powders for           materials
                   Coatings of Surgical
                   Implants
------------------------------------------------------------------------
26                ASTM F1586-02, Standard     Withdrawn     ............
                   Specification for Wrought   and
                   Nitrogen Strengthened 21    transferred
                   Chromium-Nickel-3           to
                   Manganese-2.5 Molybdenum    materials
                   Stainless Steel Bar for
                   Surgical Implants (UNS
                   S31675)
------------------------------------------------------------------------
27                ASTM F1609-95, Standard     Withdrawn     ............
                   Specification for Calcium   and
                   Phosphate Coatings for      transferred
                   Implantable materials       to
                                               materials
------------------------------------------------------------------------
28                ASTM F1713-96, Standard     Withdrawn     ............
                   Specification for Wrought   and
                   Titanium-13 Niobium-13      transferred
                   Zirconium Alloy for         to
                   Surgical Implant            materials
                   Applications
------------------------------------------------------------------------
42                ANSI/ADA Specification No.  Contact       42
                   3:1994, Dental Impression   person
                   Compound
------------------------------------------------------------------------

[[Page 61897]]

 
44                ANSI/ADA Specification No.  Contact       44
                   11:1968, Agar Impression    person
                   Material
------------------------------------------------------------------------
45                ANSI/ADA Specification No.  Contact       45
                   13:1981, Denture Cold-      person
                   Curing Repair Resin
------------------------------------------------------------------------
48                ANSI/ADA Specification No.  Contact       48
                   16:1989, Dental             person
                   Impression Paste Zinc
                   Oxide Eugenol Type
------------------------------------------------------------------------
49                ANSI/ADA Specification No.  Contact       49
                   17:1983, Denture Base       person
                   Temporary Relining Resin
------------------------------------------------------------------------
50                ANSI/ADA Specification No.  Contact       50
                   18:1992, Alginate           person
                   Impression Materials
------------------------------------------------------------------------
51                ANSI/ADA Specification No.  Contact       51
                   20:1968, Dental             person
                   Duplicating Material
------------------------------------------------------------------------
52                ANSI/ADA Specification No.  Contact       52
                   27:1993, Resin-Based        person
                   Filling Materials
------------------------------------------------------------------------
53                ANSI/ADA Specification No.  Contact       53
                   30:1990, Dental Zinc        person
                   Oxide-Eugenol and Zinc
                   Oxide Non-Eugenol Cements
------------------------------------------------------------------------
55                ANSI/ADA Specification No.  Contact       55
                   48:1983, Ultraviolet        person,
                   Activator and Disclosing    update to
                   Lights                      processes
                                               impacted to
                                               include
                                               quality
                                               system
                                               regulation
------------------------------------------------------------------------
56                ANSI/ADA Specification No.  Contact       56
                   57:1993, Endodontic         person,
                   Sealing Materials           update to
                                               processes
                                               impacted to
                                               include
                                               quality
                                               system
                                               regulation
------------------------------------------------------------------------
59                ANSI/ADA Specification No.  Withdrawn     91
                   80:2001, Color Stability    and
                   Test Procedures             replaced
                                               with newer
                                               version,
                                               update to
                                               processes
                                               impacted to
                                               include
                                               quality
                                               system
                                               regulation
------------------------------------------------------------------------
60                ANSI/ADA Specification No.  Contact       60
                   96:1994, Dental-Water-      person,
                   Based Cements               update to
                                               processes
                                               impacted to
                                               include
                                               quality
                                               system
                                               regulation
------------------------------------------------------------------------
62                ISO 1563:1990, Dental       Contact       62
                   Alginate Impression         person,
                   Material                    update to
                                               processes
                                               impacted to
                                               include
                                               quality
                                               system
                                               regulation
------------------------------------------------------------------------
63                ISO 1564:1995, Dental       Contact       63
                   Aqueous Impression          person,
                   Materials Based on Agar     update to
                                               processes
                                               impacted to
                                               include
                                               quality
                                               system
                                               regulation
------------------------------------------------------------------------
64                ISO 3107:1998, Dental Zinc  Contact       64
                   Oxide Eugenol Cements and   person,
                   Zinc Oxide Non-Eugenol      update to
                   Cements                     processes
                                               impacted to
                                               include
                                               quality
                                               system
                                               regulation
------------------------------------------------------------------------
65                ISO 3336:1993, Dentistry--  Contact       65
                   Synthetic Polymer Teeth     person,
                                               update to
                                               processes
                                               impacted to
                                               include
                                               quality
                                               system
                                               regulation
------------------------------------------------------------------------
66                ISO 4049:1998, Dentistry--  Contact       66
                   Resin-Based Filling         person,
                   Materials                   update to
                                               processes
                                               impacted to
                                               include
                                               quality
                                               system
                                               regulation
------------------------------------------------------------------------

[[Page 61898]]

 
69                ISO 6872:1995, Amendment 1- Contact       69
                   1997 Dental Ceramic         person,
                                               update to
                                               processes
                                               impacted to
                                               include
                                               quality
                                               system
                                               regulation
------------------------------------------------------------------------
71                ISO 6876:1986, Dental Root  Contact       71
                   Canal Sealing Materials     person,
                                               update to
                                               processes
                                               impacted to
                                               include
                                               quality
                                               system
                                               regulation
------------------------------------------------------------------------
72                ISO 6877:1995, Dental Root  Contact       72
                   Canal Obturating Points     person,
                                               update to
                                               processes
                                               impacted to
                                               include
                                               quality
                                               system
                                               regulation
------------------------------------------------------------------------
80                ISO 9917:1991, Dental       Contact       80
                   Water-Based Cements         person,
                                               update to
                                               processes
                                               impacted to
                                               include
                                               quality
                                               system
                                               regulation
------------------------------------------------------------------------
81                ISO 10139-1:1991,           Contact       81
                   Dentistry--Resilient        person,
                   Lining Materials for        Update to
                   Removable Dentures Part     CDRH
                   1: Short Term Materials     Offices to
                                               include OC/
                                               DE2, and
                                               update to
                                               processes
                                               impacted to
                                               include
                                               quality
                                               system
                                               regulation
------------------------------------------------------------------------
82                ISO 10477:1998, Dentistry-- Contact       82
                   Polymer-Based Crown and     person,
                   Bridge Materials            update to
                                               processes
                                               impacted to
                                               include
                                               quality
                                               system
                                               regulation
------------------------------------------------------------------------
85                ANSI/ADA Specification      Contact       85
                   15:1999, Synthetic Resin    person,
                   Teeth                       update to
                                               processes
                                               impacted to
                                               include
                                               quality
                                               system
                                               regulation
------------------------------------------------------------------------
86                ANSI/ADA Specification No.  Contact       86
                   38:2000, Metal-Ceramic      person,
                   System                      update to
                                               processes
                                               impacted to
                                               include
                                               quality
                                               system
                                               regulation
------------------------------------------------------------------------
87                ANSI/ADA Specification No.  Contact       87
                   69:1999, Dental Ceramic     person,
                                               update to
                                               processes
                                               impacted to
                                               include
                                               quality
                                               system
                                               regulation
------------------------------------------------------------------------
88                ANSI/ADA Specification No.  Contact       88
                   78:2000, Endodontic         person
                   Obturating Points
------------------------------------------------------------------------
89                ANSI/ASA Specification No.  Contact       89
                   53:1999, Polymer-Based      Person,
                   Crown and Bridge Resins     update to
                                               processes
                                               impacted to
                                               include
                                               quality
                                               system
                                               regulation
------------------------------------------------------------------------

D. General

------------------------------------------------------------------------
                                                            Replacement
   Old Item No.            Standard            Change         Item No.
------------------------------------------------------------------------
28                  IEC 60601-1-2 (Second  Transition      28
                     Edition, 2001),        statement
                     Medical Electrical     added to the
                     Equipment--Part1:      extent of
                     General Requirements   recognition
                     for Safety;
                     Electomagnetic
                     Compatibility--Requi
                     rements and Tests
------------------------------------------------------------------------

E. General Hospital/General Plastic Surgery

[[Page 61899]]



------------------------------------------------------------------------
                                                            Replacement
   Old Item No.            Standard            Change         Item No.
------------------------------------------------------------------------
13                  ISO 595/1 First        Citations and   13
                     Edition 1986-12-15,    product codes
                     Reusable All Glass
                     or Metal-and-Glass
                     Syringes for Medical
                     Use, Part 1:
                     Dimensions
------------------------------------------------------------------------
49                  ASTM D6355-98,         Withdrawn       .............
                     Standard Test Method
                     for Human Repeat
                     Insult Patch Testing
                     of Medical Gloves
------------------------------------------------------------------------
57                  USP 24 <11, Sterile Water
                     for Injection
------------------------------------------------------------------------
62                  ISO 8536-6, First      Citations and   62
                     Edition, 1996-04-01,   product codes
                     Infusion Equipment
                     for Medical Use--
                     Part 6: Freeze
                     Drying Closures for
                     Infusion Bottles
------------------------------------------------------------------------
63                  ISO 8536-7, Second     Citations and   63
                     Edition, 1999-09-01,   product codes
                     Infusion Equipment,
                     Caps made of
                     Aluminum-Plastic
                     Combinations for
                     Infusion Bottles
------------------------------------------------------------------------
76                  ISO 1135-4, Second     Citations and   76
                     Edition, 1998-03-15,   product codes
                     Transfusion
                     Equipment for
                     Medical Use--Part 4:
                     Transfusion Sets for
                     Single Use
------------------------------------------------------------------------
80                  ASTM E1112-00,         Contact person  80
                     Standards
                     Specification for
                     Electronic
                     Thermometers for
                     Intermittent
                     Determinations of
                     Patient Temperatures
------------------------------------------------------------------------
41                  USP 25, Nonabsorbable  Withdrawn and   82
                     Surgical Sutures       replaced with
                                            newer version
------------------------------------------------------------------------
50                  ASTM D6319-00ae3,      Withdrawn and   83
                     Standard               replaced with
                     Specification for      newer version
                     Nitrile Examination
                     Gloves for Medical
                     Application
------------------------------------------------------------------------
51                  ASTM D6124-01,         Withdrawn and   84
                     Standard Test Method   replaced with
                     for Residual Powder    newer version
                     on Medical Globes
------------------------------------------------------------------------
52                  ASTM D5250-00e4,       Withdrawn and   85
                     Standard               replaced with
                     Specification for      newer version
                     Poly (vinyl
                     chloride) Gloves for
                     Medical Application
------------------------------------------------------------------------
54                  ASTM D3578-01ae2,      Withdrawn and   86
                     Standard               replaced with
                     Specification for      newer version
                     Rubber Examination
                     Gloves
------------------------------------------------------------------------
55                  ASTM D3577-01ae2,      Withdrawn and   87
                     Standard               replaced with
                     Specification for      newer version
                     Rubber Surgical
                     Gloves
------------------------------------------------------------------------
56                  USP 25 <11, Sterile Sodium    replaced with
                     Chloride for           newer version
                     Irrigation
------------------------------------------------------------------------
58                  USP 25, Absorbable     Withdrawn and   89
                     Surgical Sutures       replaced with
                                            newer version
------------------------------------------------------------------------
59                  USP 25 <881, Tensile           replaced with
                     Strength               newer version
------------------------------------------------------------------------
60                  USP 25 <861, Sutures--         replaced with
                     Diameter               newer version
------------------------------------------------------------------------
61                  USP 25 <871, Sutures Needle    replaced with
                     Attachment             newer version
------------------------------------------------------------------------

F. Materials

------------------------------------------------------------------------
                                                             Replacement
  Old Item No.             Standard              Change       Item No.
------------------------------------------------------------------------
Dental 01, Ortho  ASTM F67-00, Standard       Transferred   01
 123               Specification for           from dental/
                   Unalloyed Titanium for      ENT and
                   Surgical Implant            orthopaedic
                   Applications (UNS R50250,   s
                   UNS R50550, UNS R 50700)
------------------------------------------------------------------------

[[Page 61900]]

 
Cardio 21,        ASTM F75-01, Standard       Transferred   02
 Dental 02,        Specification for Cobalt-   from
 Ortho 86          28 Chromium-6 Molybdenum    cardiovascu
                   Alloy Castings and          lar/
                   Casting Alloy for           neurology
                   Surgical Implant (UNS       dental/ENT
                   R30075)                     and
                                               orthopaedic
                                               s
------------------------------------------------------------------------
Cardio 22,        ASTM F90-01, Standard       Transferred   03
 Dental 03,        Specification for Wrought   from
 Ortho 87          Cobalt-20 Chromium-15       cardiovascu
                   Tungsten-10 Nickel Alloy    lar
                   for Surgical Implant        neurology,
                   Applications (UNS R30605)   dental/ENT
                                               and
                                               orthopaedic
                                               s
------------------------------------------------------------------------
Cardio 36,        ASTM F136-98e1, Standard    Transferred   04
 Dental 04,        Specification for Wrought   from
 Ortho 88          Titanium-6 Aluminum-4       cardiovascu
                   Vanadium ELI (Extra Low     lar/
                   Interstitial) Alloy (UNS    neurology,
                   R56401) for Surgical        dental/ENT
                   Implant Applications        and
                                               orthopaedic
                                               s
------------------------------------------------------------------------
Cardio 34,        ASTM F138-00, Standard      Transferred   05
 Dental 05,        Specification for Wrought   from
 Ortho 144         18 Chromium-14 Nickel-2.5   cardiovascu
                   Molybdenum Stainless Bar    lar/
                   and Wire for Surgical       neurology,
                   Implants (UNS S31673)       dental/ENT
                                               and
                                               orthopaedic
                                               s
------------------------------------------------------------------------
Dental 06, Ortho  ASTM F139-00, Standard      Transferred   06
 125               Specification for Wrought   from dental/
                   18 Chromium-14 Nickel-2.5   ENT and
                   Molybdenum Stainless        orthopaedic
                   Steel Sheet and Strip for   s
                   Surgical Implants (UNS
                   S31673)
------------------------------------------------------------------------
Cardio 24, Ortho  ASTM F560-98, Standard      Transferred   07
 90                Specification for           from
                   Unalloyed Tantalum for      cardiovascu
                   Surgical Implant            lar/
                   Applications (UNS R05200,   neurology
                   UNS R05400)                 and
                                               orthopaedic
                                               s
------------------------------------------------------------------------
Cardio 35,        ASTM F562-00, Standard      Transferred   08
 Dental 07,        Specification for Wrought   from
 Ortho 127         Cobalt-35 Nickel-20         cardiovascu
                   Chromium-10 Molybdenum      lar/
                   Alloy for Surgical          neurology,
                   Implant Applications        dental/ENT
                                               and
                                               orthopaedic
                                               s
------------------------------------------------------------------------
Ortho 146         ASTM F603-00, Standard      Transferred   10
                   Specification for High-     from
                   Purity Dense Aluminum       orthopaedic
                   Oxide for Surgical          s
                   Implant Application
------------------------------------------------------------------------
Dental 08, Ortho  ASTM F620-00, Standard      Transferred   11
 147               Specification for Alpha     from dental/
                   Beta Titanium Alloy         ENT and
                   Forgings for Surgical       orthopaedic
                   Implants                    s
------------------------------------------------------------------------
Dental 09, Ortho  ASTM F621-97, Standard      Transferred   12
 97                Specification for           from dental/
                   Stainless Steel Forgings    ENT and
                   for Surgical Implants       orthopaedic
                                               s
------------------------------------------------------------------------
Ortho 148         ASTM F648-00, Standard      Transferred   13
                   Specification for Ultra-    from
                   High-Molecular-Weight       orthopaedic
                   Polyethylene Powder and     s
                   Fabricated Form for
                   Surgical Implants
------------------------------------------------------------------------
Dental 10, Ortho  ASTM F688-00, Standard      Transferred   14
 128               Specification for Wrought   from dental/
                   Cobalt-35 Nickel-2.5        ENT and
                   Molybdenum Alloy Plate,     orthopaedic
                   Sheet, and Foil for         s
                   Surgical Implants (UNS
                   R30035)
------------------------------------------------------------------------
Dental 11, Ortho  ASTM F745-00, Standard      Transferred   15
 129               Specification for 18        from dental/
                   Chromium-12.5 Nickel-2.5    ENT and
                   Molybdenum Stainless        orthopaedic
                   Steel for Cast and          s
                   Solution-Annealed
                   Surgical Implant
                   Applications
------------------------------------------------------------------------
Ortho 149         ASTM F746-87 (1999),        Transferred   16
                   Standard Test Method for    from
                   Pitting or Crevice          orthopaedic
                   Corrosion of Metallic       s
                   Surgical Implant
                   Materials
------------------------------------------------------------------------
Dental 12, Ortho  ASTM F799-99, Standard      Transferred   17
 130               Specification for Cobalt-   from dental/
                   28 Chromium-6 Molybdenum    ENT and
                   Alloy Forgings for          orthopaedic
                   Surgical Implants (UNS      s
                   R31537, R31538, R31539)
------------------------------------------------------------------------
Ortho 27          ASTM F899-95, Standard      Transferred   18
                   Specification for           from
                   Stainless Steel Billet,     orthopaedic
                   Bar, and Wire for           s
                   Surgical Instruments
------------------------------------------------------------------------
Cardio 12,        ASTM F961-96, Standard      Transferred   19
 Dental 13,        Specification for Cobalt-   from
 Ortho 28          35 Nickel-20 Chromium-10    cardiovascu
                   Molybdenum Alloy Forgings   lar/
                   for Surgical Implants       neurology,
                   [UNS R30035]                dental/ENT
                                               and
                                               orthopaedic
                                               s
------------------------------------------------------------------------

[[Page 61901]]

 
Cardio 28         ASTM F1058-97, Standard     Transferred   20
                   Specification for Wrought   from
                   Cobalt-Chromium-Nickel-     cardiovascu
                   Molybdenum-Iron Alloy for   lar/
                   Surgical Implant            neurology
                   Applications
------------------------------------------------------------------------
Dental 14, Ortho  ASTM F1088-87 (1992)e1,     Transferred   21
 132               Standard Specification      from dental/
                   for Beta-Tricalcium         ENT and
                   Phosphate for Surgical      orthopaedic
                   Implantation                s
------------------------------------------------------------------------
Dental 15, Ortho  ASTM F1091-91(2000),        Transferred   22
 151               Standard Specification      from dental/
                   for Wrought Cobalt-20       ENT and
                   Chromium-15 Tungsten-10     orthopaedic
                   Nickel Alloy Surgical       s
                   Fixation Wire (UNS R
                   30605)
------------------------------------------------------------------------
Dental 16, Ortho  ASTM F1108-97a, Standard    Transferred    23
 133               Specification for Ti6A14V   from dental/
                   Alloy Castings for          ENT and
                   Surgical Implants (UNS      orthopaedic
                   R56406)                     s
------------------------------------------------------------------------
Dental 17, Ortho  ASTM F1185-88(1993)e1,      Transferred   24
 109               Standard Specification      from dental/
                   for Composition of          ENT and
                   Ceramic Hydroxylapatite     orthopaedic
                   for Surgical Implants       s
------------------------------------------------------------------------
Dental 18, Ortho  ASTM F1295-01, Standard     Transferred   25
 134               Specification for Wrought   from dental/
                   Titanium-6 Aluminum-7       ENT and
                   Niobium Alloy for           orthopaedic
                   Surgical Implant            s
                   Applications (UNS R56700)
------------------------------------------------------------------------
Dental 19, Ortho  ASTM F1314-01, Standard     Transferred   26
 40                Specification for Wrought   from dental/
                   Nitrogen Strengthened 22    ENT and
                   Chromium-13 Nickel-5        orthopaedic
                   Manganese-2.5 Molybdenum    s
                   Stainless Steel Alloy Bar
                   and Wire for Surgical
                   Implants (UNS S20910)
------------------------------------------------------------------------
Dental 20, Ortho  ASTM F1341-99, Standard     Transferred   27
 135               Specification for           for dental/
                   Unalloyed Titanium Wire     ENT and
                   UNS R50250, UNS R50400,     orthopaedic
                   UNS R50500, UNS R50700,     s
                   for Surgical Implant
                   Applications
------------------------------------------------------------------------
Dental 21, Ortho  ASTM F1350-01, Standard     Transferred    28
 154               Specification for Wrought   from dental/
                   18 Chromium-14 Nickel-      ENT and
                   2.5, Molybdenum Stainless   orthopaedic
                   Steel Surgical Fixation     s
                   Wire (UNS S31673)
------------------------------------------------------------------------
Dental 23, Ortho  ASTM F1472-00, Standard     Transferred   29
 136               Specification for Wrought   from dental/
                   Titanium-6 Aluminum-4       ENT and
                   Vanadium Alloy (UNS         orthopaedic
                   R56400) for Surgical        s
                   Implant Applications
------------------------------------------------------------------------
Dental 24, Ortho  ASTM F1537-00, Standard     Transferred   30
 137               Specification for Wrought   from dental/
                   Cobalt-28-Chromium-6-       ENT and
                   Molybdenum Alloy for        orthopaedic
                   Surgical Implants (UNS      s
                   R31537, UNS R31538, and
                   UNS R31539)
------------------------------------------------------------------------
Dental 25, Ortho  ASTM F1580-95e1, Standard   Transferred   31
 139               Specification for           from dental/
                   Titanium and Titanium-6%    ENT and
                   Aluminum-4% Vanadium        orthopaedic
                   Alloy Powders for           s
                   Coatings of Surgical
                   Implants
------------------------------------------------------------------------
Dental 26, Ortho  ASTM F1586-02, Standard     Transferred   32
 50                Specification for Wrought   from dental/
                   Nitrogen Strengthened 21    ENT and
                   Chromium-Nickel-3           orthopaedic
                   Manganese-2.5 Molybdenum    s
                   Stainless Steel Bar for
                   Surgical Implants (UNS
                   S31675)
------------------------------------------------------------------------
Dental 27, Ortho  ASTM F1609-95, Standard     Transferred   33
 51                Specification for Calcium   from dental/
                   Phosphate Coatings for      ENT and
                   Implantable Materials       orthopaedic
                                               s
------------------------------------------------------------------------
Ortho 54          ASTM F1659-95, Standard     Transferred   34
                   Test Method for Bending     from
                   and Shear Testing of        orthopaedic
                   Calcium Phosphate           s
                   Coatings on Solid
                   Metallic Substrates
------------------------------------------------------------------------
Dental 28, Ortho  ASTM F1713-96, Standard     Transferred   35
 56                Specification for Wrought   from dental
                   Titanium-13 Niobium-13      /ENT and
                   Zirconium Alloy for         orthopaedic
                   Surgical Implant            s
                   Applications
------------------------------------------------------------------------
Ortho 116         ASTM F1801-97, Standard     Transferred    36
                   Recommended Practice for    from
                   Corrosion Fatigue Testing   orthopaedic
                   of Metallic Implant         s
                   Materials
------------------------------------------------------------------------
Rad 65            ASTM F2052-00, Standard     Transferred   39
                   Test Method for             from
                   Measurement of              radiology
                   Magnetically Induced
                   Displacement Force on
                   Passive Implants in the
                   Magnetic Resonance
                   Environment
------------------------------------------------------------------------


[[Page 61902]]

G. Obstetrics and Gynecology (OB-GYN)/Gastroenterology

------------------------------------------------------------------------
                                                            Replacement
   Old Item No.            Standard            Change         Item No.
------------------------------------------------------------------------
08                  ISO 4047-1: 1996(E):   Withdrawn and   26
                     Rubber Condoms--Part   replaced with
                     1: Requirements        newer version
------------------------------------------------------------------------
09                  ISO 4074-2: 1994(E):   Withdrawn and   26
                     Rubber Condoms--Part   replaced with
                     2: Determination of    newer version
                     Length
------------------------------------------------------------------------
10                  ISO 4047-3: 1994(E):   Withdrawn and   26
                     Rubber Condoms--Part   replaced with
                     3: Determination of    newer version
                     Width
------------------------------------------------------------------------
11                  ISO 4047-5: 1996(E):   Withdrawn and    26
                     Rubber Condoms--Part   replaced with
                     5: Testing for         newer version
                     Holes--Water Leak
                     Test
------------------------------------------------------------------------
12                  ISO 4074-6: 1996(E):   Withdrawn and   26
                     Rubber Condoms--Part   replaced with
                     6: Determination of    newer version
                     Bursting Volume and
                     Pressure
------------------------------------------------------------------------
13                  ISO 4074-7: 1996(E):   Withdrawn and   26
                     Rubber Condoms--Part   replaced with
                     7: Oven Conditioning   newer version
------------------------------------------------------------------------
14                  ISO 4047-9: 1996(E):   Withdrawn and   26
                     Rubber Condoms--Part   replaced with
                     9: Determination of    newer version
                     Tensile Properties
------------------------------------------------------------------------

H. Orthopaedics

------------------------------------------------------------------------
                                                             Replacement
   Old Item No.            Standard            Change         Item No.
------------------------------------------------------------------------
27                  ASTM F899-95,          Withdrawn and   .............
                     Standard               transferred
                     Specification for      to materials
                     Stainless Steel
                     Billet, Bar, and
                     Wire for Surgical
                     Instruments
------------------------------------------------------------------------
28                  ASTM F961-96,          Withdrawn and   .............
                     Standard               Transferred
                     Specification for      to materials
                     Cobalt-35 Nickel-20
                     Chromium-10
                     Molybdenum Alloy
                     Forgings for
                     Surgical Implants
                     [UNS R30035]
------------------------------------------------------------------------
40                  ASTM F1314-01,         Withdrawn and   .............
                     Standard               Transferred
                     Specification for      to materials
                     Wrought Nitrogen
                     Strengthened 22
                     Chromium-13 Nickel-5
                     Manganese-2.5
                     Molybdenum Stainless
                     Steel Alloy Bar and
                     Wire for Surgical
                     Implants (UNS
                     S20910)
------------------------------------------------------------------------
50                  ASTM F1586-02,         Withdrawn and   .............
                     Standard               Transferred
                     Specification for      to materials
                     Wrought Nitrogen
                     Strengthened 21
                     Chromium-Nickel-3
                     Manganese-2.5
                     Molybdenum Stainless
                     Steel Bar for
                     Surgical Implants
                     (UNS S31675)
------------------------------------------------------------------------
51                  ASTM F1609-95,         Withdrawn and   .............
                     Standard               Transferred
                     Specification for      to materials
                     Calcium Phosphate
                     Coatings for
                     Implantable
                     Materials
------------------------------------------------------------------------
54                  ASTM F1659-95,         Withdrawn and   .............
                     Standard Test Method   Transferred
                     for Bending and        to materials
                     Shear Testing of
                     Calcium Phosphate
                     Coatings on Solid
                     Metallic Substrates
------------------------------------------------------------------------
56                  ASTM F1713-96,         Withdrawn and   .............
                     Standard               Transferred
                     Specification for      to materials
                     Wrought Titanium-13
                     Niobium-13 Zirconium
                     Alloy for Surgical
                     Implant Applications
------------------------------------------------------------------------
86                  ASTM F75-01, Standard  Withdrawn and   .............
                     Specification for      transferred
                     Cobalt-28 Chromium-6   to Materials
                     Molybdenum Alloy
                     Castings and Casting
                     Alloy for Surgical
                     Implant (UNS R30075)
------------------------------------------------------------------------

[[Page 61903]]

 
87                  ASTM F90-01, Standard  Withdrawn and   .............
                     Specification for      Transferred
                     Wrought Cobalt-20      to materials
                     Chromium-15 Tungsten-
                     10 Nickel Alloy for
                     Surgical Implant
                     Applications (UNS
                     R30605)
------------------------------------------------------------------------
88                  ASTM F136-98e1,        Withdrawn and   .............
                     Standard               transferred
                     Specification for      to Materials
                     Wrought Titanium-6
                     Aluminum-4 Vanadium
                     ELI (Extra Low
                     Interstitial) Alloy
                     (UNS R56401) for
                     Surgical Implant
                     Applications
------------------------------------------------------------------------
90                  ASTM F560-98,          Withdrawn and   .............
                     Standard               Transferred
                     Specification for      to materials
                     Unalloyed Tantalum
                     for Surgical Implant
                     Applications (UNS
                     R05200, UNS R05400)
------------------------------------------------------------------------
97                  ASTM F621-97,          Withdrawn and   .............
                     Standard               Transferred
                     Specification for      to materials
                     Stainless Steel
                     Forgings for
                     Surgical Implants
------------------------------------------------------------------------
109                 ASTM F1185-            Withdrawn and   .............
                     88(1993)e1, Standard   transferred
                     Specification for      to Materials
                     Composition of
                     Ceramic
                     Hydroxylapatite for
                     Surgical Implants
------------------------------------------------------------------------
116                 ASTM F1801-97,         Withdrawn and   .............
                     Standard Recommended   transferred
                     Practice for           to materials
                     Corrosion Fatigue
                     Testing of Metallic
                     Implant Materials
------------------------------------------------------------------------
123                 ASTM F67-00, Standard  Withdrawn and   .............
                     Specification for      transferred
                     Unalloyed Titanium     to materials
                     for Surgical Implant
                     Applications (UNS
                     R50250, UNS R50550,
                     UNS R 50700)
------------------------------------------------------------------------
125                 ASTM F139-00,          Withdrawn and   .............
                     Standard               transferred
                     Specification for      to materials
                     Wrought 18 Chromium-
                     14 Nickel-2.5
                     Molybdenum Stainless
                     Steel Sheet and
                     Strip for Surgical
                     Implants (UNS
                     S31673)
------------------------------------------------------------------------
127                 ASTM F562-00,          Withdrawn and   .............
                     Standard               transferred
                     Specification for      to materials
                     Wrought Cobalt-35
                     Nickel-20 Chromium-
                     10 Molybdenum Alloy
                     for Surgical Implant
                     Applications
------------------------------------------------------------------------
128                 ASTM F688-00,          Withdrawn and   .............
                     Standard               transferred
                     Specification for      to materials
                     Wrought Cobalt-35
                     Nickel-2.5
                     Molybdenum Alloy
                     Plate, Sheet, and
                     Foil for Surgical
                     Implants (UNS
                     R30035)
------------------------------------------------------------------------
129                 ASTM F745-00,          Withdrawn and   .............
                     Standard               transferred
                     Specification for 18   to materials
                     Chromium-12.5 Nickel-
                     2.5 Molybdenum
                     Stainless Steel for
                     Cast and Solution-
                     Annealed Surgical
                     Implant Applications
------------------------------------------------------------------------
130                 ASTM F799-99,          Withdrawn and   .............
                     Standard               transferred
                     Specification for      to Materials
                     Cobalt-28 Chromium-6
                     Molybdenum Alloy
                     Forgings for
                     Surgical Implants
                     (UNS R31537, R31538,
                     R31539)
------------------------------------------------------------------------
132                 ASTM F1088-87          Withdrawn and   .............
                     (1992)e1, Standard     transferred
                     Specification for      to materials
                     Beta-Tricalcium
                     Phosphate for
                     Surgical
                     Implantation
------------------------------------------------------------------------
133                 ASTM F1108-97a,        Withdrawn and   .............
                     Standard               transferred
                     Specification for      to materials
                     Ti6A14V Alloy
                     Castings for
                     Surgical Implants
                     (UNS R56406)
------------------------------------------------------------------------
134                 ASTM F1295-01,         Withdrawn and   .............
                     Standard               transferred
                     Specification for      to materials
                     Wrought Titanium-6
                     Aluminum-7 Niobium
                     Alloy for Surgical
                     Implant Applications
                     (UNS R56700)
------------------------------------------------------------------------
135                 ASTM F1341-99,         Withdrawn and   .............
                     Standard               transferred
                     Specification for      to materials
                     Unalloyed Titanium
                     Wire UNS R50250, UNS
                     R50400, UNS R50500,
                     UNS R50700, for
                     Surgical Implant
                     Applications
------------------------------------------------------------------------

[[Page 61904]]

 
136                 ASTM F1472-00,         Withdrawn and   .............
                     Standard               transferred
                     Specification for      to materials
                     Wrought Titanium-6
                     Aluminum-4 Vanadium
                     Alloy (UNS R56400)
                     for Surgical Implant
                     Applications
------------------------------------------------------------------------
137                 ASTM F1537-00,         Withdrawn and   .............
                     Standard               transferred
                     Specification for      to materials
                     Wrought Cobalt-28-
                     Chromium-6-
                     Molybdenum Alloy for
                     Surgical Implants
                     (UNS R31537, UNS
                     R31538, and UNS
                     R31539)
------------------------------------------------------------------------
138                 ASTM F1541-01,         Withdrawn and   158
                     Standard               replaced with
                     Specification and      newer version
                     Test Methods for
                     External Skeletal
                     Fixation Devices
------------------------------------------------------------------------
139                 F1580-95e1, Standard   Withdrawn and   .............
                     Specification for      transferred
                     Titanium and           to materials
                     Titanium-6% Aluminum-
                     4% Vanadium Alloy
                     Powders for Coatings
                     of Surgical Implants
------------------------------------------------------------------------
144                 ASTM F138-00,          Withdrawn and   .............
                     Standard               transferred
                     Specification for      to materials
                     Wrought 18 Chromium-
                     14 Nickel-2.5
                     Molybdenum Stainless
                     Bar and Wire for
                     Surgical Implants
                     (UNS S31673)
------------------------------------------------------------------------
146                 ASTM F603-00,          Withdrawn and   .............
                     Standard               transferred
                     Specification for      to materials
                     High-Purity Dense
                     Aluminum Oxide for
                     Surgical Implant
                     Application
------------------------------------------------------------------------
147                 ASTM F620-00,           Withdrawn and  .............
                     Standard               transferred
                     Specification for      to materials
                     Alpha Beta Titanium
                     Alloy Forgings for
                     Surgical Implants
------------------------------------------------------------------------
148                 ASTM F648-00,          Withdrawn and   .............
                     Standard               transferred
                     Specification for      to materials
                     Ultra-High-Molecular-
                     Weight Polyethylene
                     Powder and
                     Fabricated Form for
                     Surgical Implants
------------------------------------------------------------------------
149                 ASTM F746-87 (1999),   Withdrawn and   .............
                     Standard Test Method   transferred
                     for Pitting or         to materials
                     Crevice Corrosion of
                     Metallic Surgical
                     Implant Materials
------------------------------------------------------------------------
151                 ASTM F1091-91(2000),   Withdrawn and   .............
                     Standard               transferred
                     Specification for      to Materials
                     Wrought Cobalt-20
                     Chromium-15 Tungsten-
                     10 Nickel Alloy
                     Surgical Fixation
                     Wire (UNS R 30605)
------------------------------------------------------------------------
154                 ASTM F1350-01,         Withdrawn and   .............
                     Standard               transferred
                     Specification for      to materials
                     Wrought 18 Chromium-
                     14 Nickel-2.5,
                     Molybdenum Stainless
                     Steel Surgical
                     Fixation Wire (UNS
                     S31673)
------------------------------------------------------------------------

I. Physical Medicine

------------------------------------------------------------------------
                                                            Replacement
   Old Item No.            Standard            Change         Item No.
------------------------------------------------------------------------
21                  ISO 7176-6:2001,       Withdrawn and   29
                     Wheelchairs--Part 6:   replaced with
                     Determination of       newer version
                     Maximum Speed,
                     Acceleration and
                     Deceleration of
                     Electric Wheelchairs
------------------------------------------------------------------------
22                  ISO 7176-9:2001,       Withdrawn and   30
                     Wheelchairs--Part 9:   replaced with
                     Climatic Tests for     newer version
                     Electric Wheelchair
------------------------------------------------------------------------

J. Radiology

[[Page 61905]]



------------------------------------------------------------------------
                                                            Replacement
    Old Item No.         Standard           Change           Item No.
------------------------------------------------------------------------
9                    NEMA NU 1-2001,  Withdrawn and       75
                      Performance      replaced with
                      Measurements     newer version
                      of
                      Scintillation
                      Cameras
------------------------------------------------------------------------
18                   NEMA NU 2-2001,  Withdrawn and       76
                      Performance      replaced with
                      Measurement of   newer version
                      Positron
                      Emission
                      Tomographs
------------------------------------------------------------------------
46                   AIUM RTD1--      Title correction    46
                      1998, Standard
                      for Real-Time
                      Display of
                      Thermal and
                      Mechanical
                      Acoustic
                      Output Indices
                      on Diagnostic
                      Ultrasound
                      Equipment
                      Revision 1
------------------------------------------------------------------------
61                   UL 122-2001,     Title correction    61
                      Standard for
                      Safety of
                      Photographic
                      Equipment--Fou
                      rth Edition
------------------------------------------------------------------------
62                   UL 187-1998,     Title correction    62
                      Standard for
                      Safety X-ray
                      Equipment--Sev
                      enth Edition
------------------------------------------------------------------------
64                   IEC 60601-2-45,  Title correction    64
                      Ed. 2.0,
                      Medical
                      Electrical
                      Equipment:
                      Part 2-45:
                      Particular
                      Requirement
                      for the Safety
                      of
                      Mammographic X-
                      ray Equipment
                      and
                      Mammographic
                      Stereotactic
                      Devices
------------------------------------------------------------------------
66                   MUS (R 1999),    Title correction    66
                      Medical
                      Ultrasound
                      Safety
------------------------------------------------------------------------
67                   NEMA MS-1-2001,  Withdrawn and       77
                      Determination    replaced with
                      of Signal to     newer version
                      Noise Ratio
                      (SNR) in
                      Diagnostic
                      Magnetic
                      Resonance
                      Images
------------------------------------------------------------------------
70                   NEMA PS 3.15     Withdrawn and       78
                      2000, Digital    replaced with
                      Imaging and      newer version
                      Communication
                      in Medicine
                      (DICOM) Part
                      15: Security
                      Profile
------------------------------------------------------------------------
73                   UL-122 (R2001),  Withdrawn           ..............
                      Standard for
                      Safety,
                      Photographic
                      Equipment
------------------------------------------------------------------------

K. Sterility

------------------------------------------------------------------------
                                                            Replacement
   Old Item No.            Standard            Change         Item No.
------------------------------------------------------------------------
01                  AOAC 6.2.01:1995,      Product codes   01
                     Official Method
                     955.24, Testing
                     Disinfectants
                     Against Salmonella
                     choleraesuis, Use-
                     Dilution Method
------------------------------------------------------------------------
02                  AOAC 6.2.02:1995,      Product codes   02
                     Official Method
                     991.47, Testing
                     Disinfectants
                     Against Salmonella
                     choleraesuis, Hard
                     Surface Carrier Test
                     Method
------------------------------------------------------------------------
03                  AOAC 6.2.03:1995,      Product codes   03
                     Official Method
                     991.48, Testing
                     Disinfectants
                     Against
                     Staphylococcus
                     aureus, Hard Surface
                     Carrier Test Method
------------------------------------------------------------------------
04                  AOAC 6.2.04:1995,      Product codes   04
                     Official Method
                     955.15, Testing
                     Disinfectants
                     Against
                     Staphylococcus
                     aureus, Use-Dilution
                     Method
------------------------------------------------------------------------

[[Page 61906]]

 
05                  AOAC 6.2.05:1995,       Product codes  05
                     Official Method        and relevant
                     991.49, Testing        guidance
                     Disinfectants
                     Against Pseudomonas
                     aeruginosa, Hard
                     Surface Carrier Test
                     Methods
------------------------------------------------------------------------
06                  AOAC 6.2.06:1995,      Product codes   06
                     Official Method        and relevant
                     964.02, Testing        guidance
                     Disinfectants
                     Against Pseudomonas
                     aeruginosa, Use-
                     Dilution Method
------------------------------------------------------------------------
07                  AOAC 6.3.02:1995,      Product codes   07
                     Official Method        and relevant
                     955.17, Fungicidal     guidance
                     Activity of
                     Disinfectants Using
                     Trichophyton
                     mentagrophytes
------------------------------------------------------------------------
08                  AOAC 6.3.05:1995,      Product codes   08
                     Official Method        and relevant
                     966.04, Sporicidal     guidance
                     Activity of
                     Disinfectants
------------------------------------------------------------------------
09                  AOAC 6.3.06:1995,      Product codes   09
                     Official Method        and relevant
                     965.12,                guidance
                     Tuberculocidal
                     Activity of
                     Disinfectants
------------------------------------------------------------------------
10                  ANSI/AAMI ST8: 2001,   Withdrawn and   71
                     Hospital Steam         replaced with
                     Sterilization          newer version
------------------------------------------------------------------------
11                  ANSI/AAMI ST19:1994,   Withdrawn       .............
                     Biological
                     Indicators for
                     Saturated Steam
                     Sterilization
------------------------------------------------------------------------
12                  ANSI/AAMI ST21:1994,    Withdrawn      .............
                     Biological
                     Indicators for
                     Ethylene Oxide
                     Sterilization
                     Processes in Health
                     Care Facilities
------------------------------------------------------------------------
14                  AAMI/ANSI ST33:1992,   Devices         72
                     Guidance for the       affected
                     Selection and Use of
                     Reusable Rigid
                     Sterilization
                     Container Systems
                     for Ethylene Oxide
                     Sterilization and
                     Steam Sterilization
                     in Health Care
                     Facilities
------------------------------------------------------------------------
19                  AAMI/ANSI ST46:1992,   Devices         73
                     Good Hospital          affected,
                     Practice Steam         correction to
                     Sterilization and      type of
                     Sterility Assurance    standard, and
                                            relevant
                                            guidance
------------------------------------------------------------------------
22                  ANSI/AAMI ST60:1996,   Extent of       74
                     Sterilization of       Recognition
                     Health Care            and relevant
                     Products--Chemical     guidance
                     Indicators--Part 1:
                     General Requirements
------------------------------------------------------------------------
25                  AAMI/ANSI/ISO          Relevant        25
                     11135:1994, Medical    guidance
                     Devices--Validation
                     and Routine Control
                     of Ethylene Oxide
                     Sterilization
------------------------------------------------------------------------
26                  AAMI/ANSI/ISO          Withdrawn and   75
                     11137:1994,            replaced with
                     Sterilization of       newer
                     Health Care            version,
                     Products--Requiremen   relevant
                     ts for Validation      guidance
                     and Routine Control-
                     Radiation
                     Sterilization and
                     ISO 11137:1995
                     (AMENDMENT 1:2001)
------------------------------------------------------------------------
37                  AAMI/ANSI/ISO 10993-   Withdrawn and   76
                     7:1995(R) 2001,        replaced with
                     Biological             newer
                     evaluation of          version,
                     medical devices--      relevant
                     Part 7: Ethylene       guidance
                     oxide sterilization
                     residuals
------------------------------------------------------------------------
38                  ANSI/AAMI ST24:1999,   Devices         77
                     Automatic General      affected and
                     Purpose Ethylene       type of
                     Oxide Sterilizers      standard
                     and Ethylene Oxide
                     Sterilant Sources
                     Intended for Use in
                     Health Care
                     Facilities
------------------------------------------------------------------------
39                  USP 25:2002,           Withdrawn and   78
                     Biological Indicator   replaced with
                     for Dry-Heat           newer version
                     Sterilization Paper
                     Carrier
------------------------------------------------------------------------
40                  USP 25:2002,           Withdrawn and   79
                     Biological Indicator   replaced with
                     for Ethylene Oxide     newer version
                     Sterilization, Paper
                     Carrier
------------------------------------------------------------------------
41                  USP 25:2002,           Withdrawn and   80
                     Biological Indicator   replaced with
                     for Steam              newer version
                     Sterilization, Paper
                     Carrier
------------------------------------------------------------------------
42                  USP 25:2002, <61 Microbial      replaced with
                     Limits Test            newer version
------------------------------------------------------------------------

[[Page 61907]]

 
43                  USP 25:2002,           Withdrawn and   82
                     Sterility Test         replaced with
                     <71         newer version
------------------------------------------------------------------------
44                  USP 25:2002, <85, Biological    replaced with
                     Tests and Assays,      newer version
                     Bacterial Endotoxin
                     Test (LAL)
------------------------------------------------------------------------
45                  USP:2002 <151 Pyrogen Test       replaced with
                     (USP Rabbit Test)      newer version
------------------------------------------------------------------------
46                  USP:2002 <1211 Sterilization      replaced with
                     and Sterility          newer version
                     Assurance of
                     Compendial Articles
------------------------------------------------------------------------
49                  AAMI/ANSI ST41:1999,   Citations,      49
                     Ethylene Oxide         product codes
                     Sterilization in       and relevant
                     Health Care            guidance
                     Facilities: Safety
                     and Effectiveness
------------------------------------------------------------------------
52                  ANSI/AAMI ST59:1999,   Relevant        52
                     Sterilization of       guidance
                     Health Care
                     Products--Biological
                     Indicators Part 1:
                     General Requirements
------------------------------------------------------------------------
53                  AAMI/ANSI ST 66:1999,  Relevant        53
                     Sterilization of       guidance
                     Health Care
                     Products--Chemical
                     Indicators--Part 2:
                     Class 2 Indicators
                     for Air Removal Test
                     Sheets and Packs
------------------------------------------------------------------------
65                  ASTM F1980:2002,       Withdrawn and   86
                     Standard Guide for     replaced with
                     Accelerated Aging of   newer version
                     Sterile Medical
                     Device Packages
------------------------------------------------------------------------
66                  USP 25:2002, <161 Transfusion    replaced with
                     and Infusion           newer version
                     Assemblies and
                     Similar Medical
                     Devices
------------------------------------------------------------------------

III. Listing of New Entries

    FDA is adding new entries to the list of recognized standards as 
follows:

A. Biocompatibility

------------------------------------------------------------------------
                                                     Reference No. and
       Item No.             Title of Standard               Date
------------------------------------------------------------------------
65                     Standard Practice for       ASTM F2065-00
                        Testing for Alternative
                        Pathway Complement
                        Activation in Serum by
                        Solid Materials
------------------------------------------------------------------------
66                     Standard Practice for       ASTM F2148-01
                        Evaluation of Delayed
                        Contact Hypersensitivity
                        Using the Murine Local
                        Lymph Node Assay (LLNA)
------------------------------------------------------------------------
67                     Standard Practice for       ASTM F756-00
                        Assessment of Hemolytic
                        Properties of Materials
------------------------------------------------------------------------

B. Cardiovascular/Neurology

------------------------------------------------------------------------
                                                      Reference No. and
       Item No.             Title of Standard               Date
------------------------------------------------------------------------
45                     Testing and Reporting       ANSI/AAMI EC57-98
                        Performance Results of
                        Cardiac Rhythm and ST-
                        Segment Measurement
                        Algorithms
------------------------------------------------------------------------
46                     Standard Test Method for    ASTM F2079-00
                        Measuring Recoil of
                        Balloon-Expandable Stents
------------------------------------------------------------------------
47                     Standard Guide for          ASTM F2081-02
                        Characterization and
                        Presentation of the
                        Dimensional Attributes of
                        Vascular Stents
------------------------------------------------------------------------
48                     Test Method for Conducting  ASTM F2129-01
                        Cyclic Potentiodynamic
                        Polarization Measurements
                        to Determine the
                        Corrosion Susceptibility
                        of Small Implant Devices
------------------------------------------------------------------------

C. Dental/Ear, Nose, and Throat (ENT)

[[Page 61908]]



------------------------------------------------------------------------
      Item No.            Title of Standard       Reference No. and Date
------------------------------------------------------------------------
92                    Dental Brazing Alloys     ANSI/ADA Specification
                                                 No. 88:2000
------------------------------------------------------------------------
93                    Methods of Measurement    ANSI C63.19:2001
                       of Compatibility
                       Between Wireless
                       Communication Devices
                       and Hearing Aids
------------------------------------------------------------------------

D. General Hospital/General Plastic Surgery

------------------------------------------------------------------------
                                                      Reference No. and
       Item No.             Title of Standard               Date
------------------------------------------------------------------------
93                     Sterlie Water for           USP 25
                        Irrigation
------------------------------------------------------------------------
94                     Heparin Lock Flush          USP 25
                        Solution
------------------------------------------------------------------------
95                     Sodium Chloride Injection   USP 25
------------------------------------------------------------------------
96                     Standard Test Method for    ASTM F2101-01
                        Evaluating the Bacterial
                        Filtration Efficiency
                        (BFE) of Medical Face
                        Mask Materials, Using a
                        Biological Aerosol of
                        Staphylococcus aureus
------------------------------------------------------------------------

E. In Vitro Devices

------------------------------------------------------------------------
      Item No.            Title of Standard       Reference No. and Date
------------------------------------------------------------------------
62                    Laboratory Automation:    NCCLS: AUTO04-A
                       Systems Operational
                       Requirements,
                       Characteristics, and
                       Information Elements;
                       Approved Standard
------------------------------------------------------------------------
63                    Laboratory Automation:    NCCLS: AUTO05-A
                       Electromechanical
                       Interfaces; Approved
                       Standard
------------------------------------------------------------------------
64                    Point-of-Care             NCCLS: POCT1-A
                       Connectivity; Approved
                       Standard
------------------------------------------------------------------------

F. Materials

------------------------------------------------------------------------
      Item No.            Title of Standard       Reference No. and Date
------------------------------------------------------------------------
09                    Standard Specification    ASTM F563-00
                       for Wrought Cobalt-20
                       Nickel-20 Chromium-3.5
                       Molybdenum-3.5 Tungsten-
                       5 Iron Alloy for
                       Surgical Implant
                       Applications (UNS
                       R30563)
------------------------------------------------------------------------
37                    Standard Specification     ASTM F1813-01
                       for Wrought Titanium-12
                       Molybdenum-6 Zirconium-
                       2 Iron Alloy for
                       Surgical Implant (UNS
                       R58120)
------------------------------------------------------------------------
38                    Standard Terminology for  ASTM F2005-00
                       Nickel-Titanium Shape
                       Memory Alloys
------------------------------------------------------------------------
40                    Standard Specification    ASTM F2063-00
                       for Wrought Nickel-
                       Titanium Shape Memory
                       Alloys for Medical
                       Devices and Surgical
                       Implants
------------------------------------------------------------------------
41                    Standard Specification    ASTM F2066-01
                       for Wrought Titanium-15
                       Molybdenum Alloy for
                       Surgical Implant
                       Applications (UNS
                       R58150)
------------------------------------------------------------------------
42                    Standard Test Method for  ASTM F2119-01
                       Evaluation of MR Image
                       Artifacts from Passive
                       Implants
------------------------------------------------------------------------
43                    Standard Specification    ASTM F2146-01
                       for Wrought Titanium-3
                       Aluminum-2.5 Vanadium
                       Alloy Seamless Tubing
                       for Surgical Implant
                       Applications (UNS
                       R56320)
------------------------------------------------------------------------


[[Page 61909]]

G. OB-GYN/Gastroenterology

------------------------------------------------------------------------
      Item No.            Title of Standard       Reference No. and Date
------------------------------------------------------------------------
26                    Natural Latex Rubber      ISO 4074:2000(E)
                       Condoms--Requirements
                       and Test methods
------------------------------------------------------------------------
27                    Standard Test Methods     ASTM D6324-99a
                       for Male Condoms Made
                       from Synthetic
                       Materials
------------------------------------------------------------------------

H. Ophthalmic

------------------------------------------------------------------------
      Item No.            Title of Standard       Reference No. and Date
------------------------------------------------------------------------
30                    Intraocular Lenses        ANSI Z80.7:2001
------------------------------------------------------------------------

I. Radiology

------------------------------------------------------------------------
      Item No.            Title of Standard       Reference No. and Date
------------------------------------------------------------------------
79                    High Voltage X-ray        NEMA XR 7-1995 (R2000)
                       Cables and Receptacles
------------------------------------------------------------------------
80                    Power Supply Guidelines   NEMA XR 9-1984 (R1994,
                       for X-ray Machines        R2000)
------------------------------------------------------------------------
81                    Mechanical Safety         NEMA XR 13-1990 (R1995,
                       Standard for Power        R2000)
                       Driven Motions of
                       Electromedical
                       Equipment
------------------------------------------------------------------------
82                    Recommended Practices     NEMA XR 14-1990 (R1995,
                       for Load Bearing          R2000)
                       Mechanical Assemblies
                       Used in Diagnostic
                       Imaging
------------------------------------------------------------------------
83                    Medical Electrical        IEC 60601-2-37 (2001-07)
                       Equipment, Part 2-37:
                       Particular Requirements
                       for the Safety of
                       Ultrasonic Medical
                       Diagnostic and
                       Monitoring Equipment
------------------------------------------------------------------------
84                    Consol. Ed. 1.2 (incl.    IEC 60825-1 (2001-08)
                       am1+am2), Safety of
                       Laser Products--Part 1:
                       Equipment
                       Classification,
                       Requirements and User's
                       Guide
------------------------------------------------------------------------
85                    Ed. 2.0, Medical          IEC 60601-2-22 (1995-11)
                       Electrical Equipment--
                       Part 2: Particular
                       Requirements for the
                       Safety of Diagnostic
                       and Therapeutic Laser
                       Equipment
------------------------------------------------------------------------

J. Sterility

------------------------------------------------------------------------
      Item No.            Title of Standard       Reference No. and Date
------------------------------------------------------------------------
88                    Sterilization of Health   ANSI/AAMI/ISO 14937:2000
                       Care Products--General
                       Requirements for
                       Characterization of a
                       Sterilizing Agent and
                       the Development,
                       Validation, and Routine
                       Control of a
                       Sterilization Process
                       for Medical Devices
------------------------------------------------------------------------
89                    Standard Test Method for  ASTM F2054-00
                       Burst Testing of
                       Flexible Package Seals
                       Using Internal Air
                       Pressurization Within
                       Restraining Plates
------------------------------------------------------------------------
90                    Standard Test Methods     ASTM F2095-01
                       for Pressure Decay Leak
                       Test for Nonporous
                       Flexible Packages With
                       and Without Restraining
                       Plates
------------------------------------------------------------------------
91                    Standard Test Method for  ASTM F2096-1
                       Detecting Gross Leaks
                       in Porous Medical
                       Packaging by Internal
                       Pressurization (Bubble
                       Test)
------------------------------------------------------------------------
92                    Standard Guide for        ASTM F2097-01
                       Design and Evaluation
                       of Primary Packaging
                       for Medical Products
------------------------------------------------------------------------
93                    Biological Indicator for  USP 25:2002
                       Steam Sterilization--
                       Self Contained
------------------------------------------------------------------------


[[Page 61910]]

IV. Recommendation of Standards for Recognition by FDA

    Any person may recommend consensus standards as candidates for 
recognition under 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.

V. 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 ([numsign]). 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: 007'' 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.

VI. Submission of Comments

    You may, at any time, submit to the contact person (see FOR FURTHER 
INFORMATION CONTACT) written comments regarding this document. You 
should submit two copies of any comments, except that individuals may 
submit one copy. You must 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: 007.''

    Dated: September 18, 2002.
Linda S. Kahan,
Deputy Director, Center for Devices and Radiological Health.
[FR Doc. 02-24954 Filed 10-1-02; 8:45 am]
BILLING CODE 4160-01-S