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Notice

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

Document Details

Information about this document as published in the Federal Register.

Published Document

This document has been published in the Federal Register. Use the PDF linked in the document sidebar for the official electronic format.

Start Preamble

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.

Start Further Info

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.

End Further Info End Preamble Start Supplemental Information

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 Start Printed Page 61894will 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:

  • Withdrawn and replaced with a newer version
  • Withdrawn and transferred to materials
  • Contact person
  • Transition statement added to the extend of recognition
  • Citations and product codes
  • Withdrawn
  • Title correction
  • Product codes and relevant guidance
  • Devices affected
  • 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

Old Item No.StandardChangeReplacement Item No.
12ASTM F813-01, Standard Practice for Direct Contact Cell Culture Evaluation of Materials for Medical DevicesWithdrawn and replaced with newer version 56
13ASTM E895-84 (2001)e1, Standard Test Method for Agar Diffusion Cell Culture Screening for CytotoxicityWithdrawn and replaced with newer version57
46USP 25—NF20, Biological Tests <87>, Biological Reactivity Test, In Vitro—Direct Contact TestWithdrawn and replaced with newer version58
47USP 25—NF20, Biological Tests <88>, Biological Reactivity Test, In Vitro—Elution TestWithdrawn and replaced with newer version59
48USP 25—NF20, Biological Tests <88>, Biological Reactivity Test, In Vivo, Classification of Plastics—Simple PreparationWithdrawn and replaced with newer version60
49USP 25—NF20, Biological Tests <88>, Biological Reactivity Test, In Vivo—Intracutaneous TestWithdrawn and replaced with newer version61
50USP 25—NF20, Biological Tests <88>, Biological Reactivity Test, In Vivo—Systemic Injection TestWithdrawn and replaced with newer version62
55ANSI/AAMI/ISO 10993-6:1995/(R)2001: Biological evaluation of medical devices—Part 6: Test for local effects after implantationWithdrawn and replaced with newer version63
54ANSI/AAMI/ISO 10993-5: Biological evaluation of medical devices—Part 5: Tests for in vitro cytotoxicityWithdrawn and replaced with change in extent of recognition64

B. Cardiovascular/Neurology

Old Item No.StandardChangeReplacement Item No.
12ASTM F961-96, Standard Specification for Cobalt-35 Nickel-20 Chromium-10 Molybdenum Alloy Forgings for Surgical Implants [UNS R30035]Withdrawn and transferred to materials
21ASTM F75-01, Standard Specification for Cobalt-28 Chromium-6 Molybdenum Alloy Castings and Casting Alloy for Surgical Implant (UNS R30075)Withdrawn and transferred to materials
22ASTM F90-01, Standard Specification for Wrought Cobalt-20 Chromium-15 Tungsten-10 Nickel Alloy for Surgical Implant Applications (UNS R30605)Withdrawn and transferred to materials
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24ASTM F560-98, Standard Specification for Unalloyed Tantalum for Surgical Implant Applications (UNS R05200, UNS R05400)Withdrawn and transferred to materials
28ASTM F1058-97, Standard Specification for Wrought Cobalt-Chromium-Nickel-Molybdenum-Iron Alloy for Surgical Implant ApplicationsWithdrawn and transferred to materials
34ASTM F138-00, Standard Specification for Wrought 18 Chromium-14 Nickel-2.5 Molybdenum Stainless Bar and Wire for Surgical Implants (UNS S31673)Withdrawn and transferred to materials
35ASTM F562-00, Standard Specification for Wrought Cobalt-35 Nickel-20 Chromium-10 Molybdenum Alloy for Surgical Implant ApplicationsWithdrawn and transferred to materials
36ASTM F136-98e1, Standard Specification for Wrought Titanium-6 Aluminum-4 Vanadium ELI (Extra Low Interstitial) Alloy (UNS R56401) for Surgical Implant ApplicationsWithdrawn and transferred to materials

C. Dental/ENT

Old Item No.StandardChangeReplacement Item No.
01ASTM F67-00, Standard Specification for Unalloyed Titanium for Surgical Implant Applications (UNS R50250, UNS R50550, UNS R50700)Withdrawn and transferred to materials
02ASTM F75-01, Standard Specification for Cobalt-28 Chromium-6 Molybdenum Alloy Castings and Casting Alloy for Surgical Implant (UNS R 30075)Withdrawn and transferred to materials
03ASTM F90-01, Standard Specification for Wrought Cobalt-20 Chromium-15 Tungsten-10 Nickel Alloy for Surgical Implant Applications (UNS R30605)Withdrawn and transferred to materials
04ASTM F136-98e1, Standard Specification for Wrought Titanium-6 Aluminum-4 Vanadium ELI (Extra Low Interstitial) Alloy (UNS R56401) for Surgical Implant ApplicationsWithdrawn and transferred to materials
05ASTM F138-00, Standard Specification for Wrought 18 Chromium-14 Nickel-2.5 Molybdenum Stainless Bar and Wire for Surgical Implants (UNS S31673)Withdrawn and transferred to materials
06ASTM F139-00, Standard Specification for Wrought 18 Chromium-14 Nickel-2.5 Molybdenum Stainless Steel Sheet and Strip for Surgical Implants (UNS S31673)Withdrawn and transferred to materials
07ASTM F562-00, Standard Specification for Wrought Cobalt-35 Nickel-20 Chromium-10 Molybdenum Alloy for Surgical Implant ApplicationsWithdrawn and transferred to materials
08ASTM F620-00, Standard Specification for Alpha Beta Titanium Alloy Forgings for Surgical ImplantsWithdrawn and transferred to materials
09ASTM F621-97, Standard Specification for Stainless Steel Forgings for Surgical ImplantsWithdrawn and transferred to materials
10ASTM F688-00, Standard Specification for Wrought Cobalt-35 Nickel-2.5 Molybdenum Alloy Plate, Sheet, and Foil for Surgical Implants (UNS R30035)Withdrawn and transferred to materials
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11ASTM F745-00, Standard Specification for 18 Chromium-12.5 Nickel-2.5 Molybdenum Stainless Steel for Cast and Solution-Annealed Surgical Implant ApplicationsWithdrawn and transferred to materials
12ASTM F799-99, Standard Specification for Cobalt-28 Chromium-6 Molybdenum Alloy Forgings for Surgical Implants (UNS R31537, R31538, R31539)Withdrawn and transferred to materials
13ASTM F961-96, Standard Specification for Cobalt-35 Nickel-20 Chromium-10 Molybdenum Alloy Forgings for Surgical Implants [UNS R30035]Withdrawn and transferred to materials
14ASTM F1088-87 (1992)e1, Standard Specification for Beta-Tricalcium Phosphate for Surgical ImplantationWithdrawn and transferred to materials
15ASTM F1091-91(2000), Standard Specification for Wrought Cobalt-20 Chromium-15 Tungsten-10 Nickel Alloy Surgical Fixation Wire (UNS R 30605)Withdrawn and transferred to materials
16ASTM F1108-97a, Standard Specification for Ti6A14V Alloy Castings for Surgical Implants (UNS R56406)Withdrawn and transferred to materials
17ASTM F1185-88(1993)e1, Standard Specification for Composition of Ceramic Hydroxylapatite for Surgical ImplantsWithdrawn and transferred to materials
18ASTM F1295-01, Standard Specification for Wrought Titanium-6 Aluminum-7 Niobium Alloy for Surgical Implant Applications (UNS R56700)Withdrawn and transferred to materials
19ASTM F1314-01, Standard Specification for Wrought Nitrogen Strengthened 22 Chromium-13 Nickel-5 Manganese-2.5 Molybdenum Stainless Steel Alloy Bar and Wire for Surgical Implants (UNS S20910)Withdrawn and transferred to materials
20ASTM F1341-99, Standard Specification for Unalloyed Titanium Wire UNS R50250, UNS R50400, UNS R50500, UNS R50700, for Surgical Implant ApplicationsWithdrawn and transferred to materials
21ASTM F1350-01, Standard Specification for Wrought 18 Chromium-14 Nickel-2.5, Molybdenum Stainless Steel Surgical Fixation Wire (UNS S31673)Withdrawn and transferred to materials
23ASTM F1472-00, Standard Specification for Wrought Titanium-6 Aluminum-4 Vanadium Alloy (UNS R56400) for Surgical Implant ApplicationsWithdrawn and transferred to materials
24ASTM F1537-00, Standard Specification for Wrought Cobalt-28-Chromium-6-Molybdenum Alloy for Surgical Implants (UNS R31537, UNS R31538, and UNS R31539)Withdrawn and transferred to materials
25F1580-95e1, Standard Specification for Titanium and Titanium-6% Aluminum-4% Vanadium Alloy Powders for Coatings of Surgical ImplantsWithdrawn and transferred to materials
26ASTM F1586-02, Standard Specification for Wrought Nitrogen Strengthened 21 Chromium-Nickel-3 Manganese-2.5 Molybdenum Stainless Steel Bar for Surgical Implants (UNS S31675)Withdrawn and transferred to materials
27ASTM F1609-95, Standard Specification for Calcium Phosphate Coatings for Implantable materialsWithdrawn and transferred to materials
28ASTM F1713-96, Standard Specification for Wrought Titanium-13 Niobium-13 Zirconium Alloy for Surgical Implant ApplicationsWithdrawn and transferred to materials
42ANSI/ADA Specification No. 3:1994, Dental Impression CompoundContact person42
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44ANSI/ADA Specification No. 11:1968, Agar Impression MaterialContact person44
45ANSI/ADA Specification No. 13:1981, Denture Cold-Curing Repair ResinContact person45
48ANSI/ADA Specification No. 16:1989, Dental Impression Paste Zinc Oxide Eugenol TypeContact person48
49ANSI/ADA Specification No. 17:1983, Denture Base Temporary Relining ResinContact person49
50ANSI/ADA Specification No. 18:1992, Alginate Impression MaterialsContact person50
51ANSI/ADA Specification No. 20:1968, Dental Duplicating MaterialContact person51
52ANSI/ADA Specification No. 27:1993, Resin-Based Filling MaterialsContact person52
53ANSI/ADA Specification No. 30:1990, Dental Zinc Oxide-Eugenol and Zinc Oxide Non-Eugenol CementsContact person53
55ANSI/ADA Specification No. 48:1983, Ultraviolet Activator and Disclosing LightsContact person, update to processes impacted to include quality system regulation55
56ANSI/ADA Specification No. 57:1993, Endodontic Sealing MaterialsContact person, update to processes impacted to include quality system regulation56
59ANSI/ADA Specification No. 80:2001, Color Stability Test ProceduresWithdrawn and replaced with newer version, update to processes impacted to include quality system regulation91
60ANSI/ADA Specification No. 96:1994, Dental-Water-Based CementsContact person, update to processes impacted to include quality system regulation60
62ISO 1563:1990, Dental Alginate Impression MaterialContact person, update to processes impacted to include quality system regulation62
63ISO 1564:1995, Dental Aqueous Impression Materials Based on AgarContact person, update to processes impacted to include quality system regulation63
64ISO 3107:1998, Dental Zinc Oxide Eugenol Cements and Zinc Oxide Non-Eugenol CementsContact person, update to processes impacted to include quality system regulation64
65ISO 3336:1993, Dentistry—Synthetic Polymer TeethContact person, update to processes impacted to include quality system regulation65
66ISO 4049:1998, Dentistry—Resin-Based Filling MaterialsContact person, update to processes impacted to include quality system regulation66
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69ISO 6872:1995, Amendment 1-1997 Dental CeramicContact person, update to processes impacted to include quality system regulation69
71ISO 6876:1986, Dental Root Canal Sealing MaterialsContact person, update to processes impacted to include quality system regulation71
72ISO 6877:1995, Dental Root Canal Obturating PointsContact person, update to processes impacted to include quality system regulation72
80ISO 9917:1991, Dental Water-Based CementsContact person, update to processes impacted to include quality system regulation80
81ISO 10139-1:1991, Dentistry—Resilient Lining Materials for Removable Dentures Part 1: Short Term MaterialsContact person, Update to CDRH Offices to include OC/DE2, and update to processes impacted to include quality system regulation81
82ISO 10477:1998, Dentistry—Polymer-Based Crown and Bridge MaterialsContact person, update to processes impacted to include quality system regulation82
85ANSI/ADA Specification 15:1999, Synthetic Resin TeethContact person, update to processes impacted to include quality system regulation85
86ANSI/ADA Specification No. 38:2000, Metal-Ceramic SystemContact person, update to processes impacted to include quality system regulation86
87ANSI/ADA Specification No. 69:1999, Dental CeramicContact person, update to processes impacted to include quality system regulation87
88ANSI/ADA Specification No. 78:2000, Endodontic Obturating PointsContact person88
89ANSI/ASA Specification No. 53:1999, Polymer-Based Crown and Bridge ResinsContact Person, update to processes impacted to include quality system regulation89

D. General

Old Item No.StandardChangeReplacement Item No.
28IEC 60601-1-2 (Second Edition, 2001), Medical Electrical Equipment—Part1: General Requirements for Safety; Electomagnetic Compatibility—Requirements and TestsTransition statement added to the extent of recognition28

E. General Hospital/General Plastic Surgery

Start Printed Page 61899
Old Item No.StandardChangeReplacement Item No.
13ISO 595/1 First Edition 1986-12-15, Reusable All Glass or Metal-and-Glass Syringes for Medical Use, Part 1: DimensionsCitations and product codes13
49ASTM D6355-98, Standard Test Method for Human Repeat Insult Patch Testing of Medical GlovesWithdrawn
57USP 24 <11>, Sterile Water for InjectionWithdrawn
62ISO 8536-6, First Edition, 1996-04-01, Infusion Equipment for Medical Use—Part 6: Freeze Drying Closures for Infusion BottlesCitations and product codes62
63ISO 8536-7, Second Edition, 1999-09-01, Infusion Equipment, Caps made of Aluminum-Plastic Combinations for Infusion BottlesCitations and product codes63
76ISO 1135-4, Second Edition, 1998-03-15, Transfusion Equipment for Medical Use—Part 4: Transfusion Sets for Single UseCitations and product codes76
80ASTM E1112-00, Standards Specification for Electronic Thermometers for Intermittent Determinations of Patient TemperaturesContact person80
41USP 25, Nonabsorbable Surgical SuturesWithdrawn and replaced with newer version82
50ASTM D6319-00ae3, Standard Specification for Nitrile Examination Gloves for Medical ApplicationWithdrawn and replaced with newer version83
51ASTM D6124-01, Standard Test Method for Residual Powder on Medical GlobesWithdrawn and replaced with newer version84
52ASTM D5250-00e4, Standard Specification for Poly (vinyl chloride) Gloves for Medical ApplicationWithdrawn and replaced with newer version85
54ASTM D3578-01ae2, Standard Specification for Rubber Examination GlovesWithdrawn and replaced with newer version86
55ASTM D3577-01ae2, Standard Specification for Rubber Surgical GlovesWithdrawn and replaced with newer version87
56USP 25 <11>, Sterile Sodium Chloride for IrrigationWithdrawn and replaced with newer version88
58USP 25, Absorbable Surgical SuturesWithdrawn and replaced with newer version89
59USP 25 <881>, Tensile StrengthWithdrawn and replaced with newer version90
60USP 25 <861>, Sutures—DiameterWithdrawn and replaced with newer version91
61USP 25 <871>, Sutures Needle AttachmentWithdrawn and replaced with newer version92

F. Materials

Old Item No.StandardChangeReplacement Item No.
Dental 01, Ortho 123ASTM F67-00, Standard Specification for Unalloyed Titanium for Surgical Implant Applications (UNS R50250, UNS R50550, UNS R 50700)Transferred from dental/ENT and orthopaedics01
Start Printed Page 61900
Cardio 21, Dental 02, Ortho 86ASTM F75-01, Standard Specification for Cobalt-28 Chromium-6 Molybdenum Alloy Castings and Casting Alloy for Surgical Implant (UNS R30075)Transferred from cardiovascular/neurology dental/ENT and orthopaedics02
Cardio 22, Dental 03, Ortho 87ASTM F90-01, Standard Specification for Wrought Cobalt-20 Chromium-15 Tungsten-10 Nickel Alloy for Surgical Implant Applications (UNS R30605)Transferred from cardiovascular neurology, dental/ENT and orthopaedics03
Cardio 36, Dental 04, Ortho 88ASTM F136-98e1, Standard Specification for Wrought Titanium-6 Aluminum-4 Vanadium ELI (Extra Low Interstitial) Alloy (UNS R56401) for Surgical Implant ApplicationsTransferred from cardiovascular/neurology, dental/ENT and orthopaedics04
Cardio 34, Dental 05, Ortho 144ASTM F138-00, Standard Specification for Wrought 18 Chromium-14 Nickel-2.5 Molybdenum Stainless Bar and Wire for Surgical Implants (UNS S31673)Transferred from cardiovascular/neurology, dental/ENT and orthopaedics05
Dental 06, Ortho 125ASTM F139-00, Standard Specification for Wrought 18 Chromium-14 Nickel-2.5 Molybdenum Stainless Steel Sheet and Strip for Surgical Implants (UNS S31673)Transferred from dental/ENT and orthopaedics06
Cardio 24, Ortho 90ASTM F560-98, Standard Specification for Unalloyed Tantalum for Surgical Implant Applications (UNS R05200, UNS R05400)Transferred from cardiovascular/neurology and orthopaedics07
Cardio 35, Dental 07, Ortho 127ASTM F562-00, Standard Specification for Wrought Cobalt-35 Nickel-20 Chromium-10 Molybdenum Alloy for Surgical Implant ApplicationsTransferred from cardiovascular/neurology, dental/ENT and orthopaedics08
Ortho 146ASTM F603-00, Standard Specification for High-Purity Dense Aluminum Oxide for Surgical Implant ApplicationTransferred from orthopaedics10
Dental 08, Ortho 147ASTM F620-00, Standard Specification for Alpha Beta Titanium Alloy Forgings for Surgical ImplantsTransferred from dental/ENT and orthopaedics11
Dental 09, Ortho 97ASTM F621-97, Standard Specification for Stainless Steel Forgings for Surgical ImplantsTransferred from dental/ENT and orthopaedics12
Ortho 148ASTM F648-00, Standard Specification for Ultra-High-Molecular-Weight Polyethylene Powder and Fabricated Form for Surgical ImplantsTransferred from orthopaedics13
Dental 10, Ortho 128ASTM F688-00, Standard Specification for Wrought Cobalt-35 Nickel-2.5 Molybdenum Alloy Plate, Sheet, and Foil for Surgical Implants (UNS R30035)Transferred from dental/ENT and orthopaedics14
Dental 11, Ortho 129ASTM F745-00, Standard Specification for 18 Chromium-12.5 Nickel-2.5 Molybdenum Stainless Steel for Cast and Solution-Annealed Surgical Implant ApplicationsTransferred from dental/ENT and orthopaedics15
Ortho 149ASTM F746-87 (1999), Standard Test Method for Pitting or Crevice Corrosion of Metallic Surgical Implant MaterialsTransferred from orthopaedics16
Dental 12, Ortho 130ASTM F799-99, Standard Specification for Cobalt-28 Chromium-6 Molybdenum Alloy Forgings for Surgical Implants (UNS R31537, R31538, R31539)Transferred from dental/ENT and orthopaedics17
Ortho 27ASTM F899-95, Standard Specification for Stainless Steel Billet, Bar, and Wire for Surgical InstrumentsTransferred from orthopaedics18
Cardio 12, Dental 13, Ortho 28ASTM F961-96, Standard Specification for Cobalt-35 Nickel-20 Chromium-10 Molybdenum Alloy Forgings for Surgical Implants [UNS R30035]Transferred from cardiovascular/neurology, dental/ENT and orthopaedics19
Start Printed Page 61901
Cardio 28ASTM F1058-97, Standard Specification for Wrought Cobalt-Chromium-Nickel-Molybdenum-Iron Alloy for Surgical Implant ApplicationsTransferred from cardiovascular/neurology20
Dental 14, Ortho 132ASTM F1088-87 (1992)e1, Standard Specification for Beta-Tricalcium Phosphate for Surgical ImplantationTransferred from dental/ENT and orthopaedics21
Dental 15, Ortho 151ASTM F1091-91(2000), Standard Specification for Wrought Cobalt-20 Chromium-15 Tungsten-10 Nickel Alloy Surgical Fixation Wire (UNS R 30605)Transferred from dental/ENT and orthopaedics22
Dental 16, Ortho 133ASTM F1108-97a, Standard Specification for Ti6A14V Alloy Castings for Surgical Implants (UNS R56406)Transferred from dental/ENT and orthopaedics23
Dental 17, Ortho 109ASTM F1185-88(1993)e1, Standard Specification for Composition of Ceramic Hydroxylapatite for Surgical ImplantsTransferred from dental/ENT and orthopaedics24
Dental 18, Ortho 134ASTM F1295-01, Standard Specification for Wrought Titanium-6 Aluminum-7 Niobium Alloy for Surgical Implant Applications (UNS R56700)Transferred from dental/ENT and orthopaedics25
Dental 19, Ortho 40ASTM F1314-01, Standard Specification for Wrought Nitrogen Strengthened 22 Chromium-13 Nickel-5 Manganese-2.5 Molybdenum Stainless Steel Alloy Bar and Wire for Surgical Implants (UNS S20910)Transferred from dental/ENT and orthopaedics26
Dental 20, Ortho 135ASTM F1341-99, Standard Specification for Unalloyed Titanium Wire UNS R50250, UNS R50400, UNS R50500, UNS R50700, for Surgical Implant ApplicationsTransferred for dental/ENT and orthopaedics27
Dental 21, Ortho 154ASTM F1350-01, Standard Specification for Wrought 18 Chromium-14 Nickel-2.5, Molybdenum Stainless Steel Surgical Fixation Wire (UNS S31673)Transferred from dental/ENT and orthopaedics28
Dental 23, Ortho 136ASTM F1472-00, Standard Specification for Wrought Titanium-6 Aluminum-4 Vanadium Alloy (UNS R56400) for Surgical Implant ApplicationsTransferred from dental/ENT and orthopaedics29
Dental 24, Ortho 137ASTM F1537-00, Standard Specification for Wrought Cobalt-28-Chromium-6-Molybdenum Alloy for Surgical Implants (UNS R31537, UNS R31538, and UNS R31539)Transferred from dental/ENT and orthopaedics30
Dental 25, Ortho 139ASTM F1580-95e1, Standard Specification for Titanium and Titanium-6% Aluminum-4% Vanadium Alloy Powders for Coatings of Surgical ImplantsTransferred from dental/ENT and orthopaedics31
Dental 26, Ortho 50ASTM F1586-02, Standard Specification for Wrought Nitrogen Strengthened 21 Chromium-Nickel-3 Manganese-2.5 Molybdenum Stainless Steel Bar for Surgical Implants (UNS S31675)Transferred from dental/ENT and orthopaedics32
Dental 27, Ortho 51ASTM F1609-95, Standard Specification for Calcium Phosphate Coatings for Implantable MaterialsTransferred from dental/ENT and orthopaedics33
Ortho 54ASTM F1659-95, Standard Test Method for Bending and Shear Testing of Calcium Phosphate Coatings on Solid Metallic SubstratesTransferred from orthopaedics34
Dental 28, Ortho 56ASTM F1713-96, Standard Specification for Wrought Titanium-13 Niobium-13 Zirconium Alloy for Surgical Implant ApplicationsTransferred from dental /ENT and orthopaedics35
Ortho 116ASTM F1801-97, Standard Recommended Practice for Corrosion Fatigue Testing of Metallic Implant MaterialsTransferred from orthopaedics36
Rad 65ASTM F2052-00, Standard Test Method for Measurement of Magnetically Induced Displacement Force on Passive Implants in the Magnetic Resonance EnvironmentTransferred from radiology39
Start Printed Page 61902

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

Old Item No.StandardChangeReplacement Item No.
08ISO 4047-1: 1996(E): Rubber Condoms—Part 1: RequirementsWithdrawn and replaced with newer version26
09ISO 4074-2: 1994(E): Rubber Condoms—Part 2: Determination of LengthWithdrawn and replaced with newer version26
10ISO 4047-3: 1994(E): Rubber Condoms—Part 3: Determination of WidthWithdrawn and replaced with newer version26
11ISO 4047-5: 1996(E): Rubber Condoms—Part 5: Testing for Holes—Water Leak TestWithdrawn and replaced with newer version26
12ISO 4074-6: 1996(E): Rubber Condoms—Part 6: Determination of Bursting Volume and PressureWithdrawn and replaced with newer version26
13ISO 4074-7: 1996(E): Rubber Condoms—Part 7: Oven ConditioningWithdrawn and replaced with newer version26
14ISO 4047-9: 1996(E): Rubber Condoms—Part 9: Determination of Tensile PropertiesWithdrawn and replaced with newer version26

H. Orthopaedics

Old Item No.StandardChangeReplacement Item No.
27ASTM F899-95, Standard Specification for Stainless Steel Billet, Bar, and Wire for Surgical InstrumentsWithdrawn and transferred to materials
28ASTM F961-96, Standard Specification for Cobalt-35 Nickel-20 Chromium-10 Molybdenum Alloy Forgings for Surgical Implants [UNS R30035]Withdrawn and Transferred to materials
40ASTM F1314-01, Standard Specification for Wrought Nitrogen Strengthened 22 Chromium-13 Nickel-5 Manganese-2.5 Molybdenum Stainless Steel Alloy Bar and Wire for Surgical Implants (UNS S20910)Withdrawn and Transferred to materials
50ASTM F1586-02, Standard Specification for Wrought Nitrogen Strengthened 21 Chromium-Nickel-3 Manganese-2.5 Molybdenum Stainless Steel Bar for Surgical Implants (UNS S31675)Withdrawn and Transferred to materials
51ASTM F1609-95, Standard Specification for Calcium Phosphate Coatings for Implantable MaterialsWithdrawn and Transferred to materials
54ASTM F1659-95, Standard Test Method for Bending and Shear Testing of Calcium Phosphate Coatings on Solid Metallic SubstratesWithdrawn and Transferred to materials
56ASTM F1713-96, Standard Specification for Wrought Titanium-13 Niobium-13 Zirconium Alloy for Surgical Implant ApplicationsWithdrawn and Transferred to materials
86ASTM F75-01, Standard Specification for Cobalt-28 Chromium-6 Molybdenum Alloy Castings and Casting Alloy for Surgical Implant (UNS R30075)Withdrawn and transferred to Materials
Start Printed Page 61903
87ASTM F90-01, Standard Specification for Wrought Cobalt-20 Chromium-15 Tungsten-10 Nickel Alloy for Surgical Implant Applications (UNS R30605)Withdrawn and Transferred to materials
88ASTM F136-98e1, Standard Specification for Wrought Titanium-6 Aluminum-4 Vanadium ELI (Extra Low Interstitial) Alloy (UNS R56401) for Surgical Implant ApplicationsWithdrawn and transferred to Materials
90ASTM F560-98, Standard Specification for Unalloyed Tantalum for Surgical Implant Applications (UNS R05200, UNS R05400)Withdrawn and Transferred to materials
97ASTM F621-97, Standard Specification for Stainless Steel Forgings for Surgical ImplantsWithdrawn and Transferred to materials
109ASTM F1185-88(1993)e1, Standard Specification for Composition of Ceramic Hydroxylapatite for Surgical ImplantsWithdrawn and transferred to Materials
116ASTM F1801-97, Standard Recommended Practice for Corrosion Fatigue Testing of Metallic Implant MaterialsWithdrawn and transferred to materials
123ASTM F67-00, Standard Specification for Unalloyed Titanium for Surgical Implant Applications (UNS R50250, UNS R50550, UNS R 50700)Withdrawn and transferred to materials
125ASTM F139-00, Standard Specification for Wrought 18 Chromium-14 Nickel-2.5 Molybdenum Stainless Steel Sheet and Strip for Surgical Implants (UNS S31673)Withdrawn and transferred to materials
127ASTM F562-00, Standard Specification for Wrought Cobalt-35 Nickel-20 Chromium-10 Molybdenum Alloy for Surgical Implant ApplicationsWithdrawn and transferred to materials
128ASTM F688-00, Standard Specification for Wrought Cobalt-35 Nickel-2.5 Molybdenum Alloy Plate, Sheet, and Foil for Surgical Implants (UNS R30035)Withdrawn and transferred to materials
129ASTM F745-00, Standard Specification for 18 Chromium-12.5 Nickel-2.5 Molybdenum Stainless Steel for Cast and Solution-Annealed Surgical Implant ApplicationsWithdrawn and transferred to materials
130ASTM F799-99, Standard Specification for Cobalt-28 Chromium-6 Molybdenum Alloy Forgings for Surgical Implants (UNS R31537, R31538, R31539)Withdrawn and transferred to Materials
132ASTM F1088-87 (1992)e1, Standard Specification for Beta-Tricalcium Phosphate for Surgical ImplantationWithdrawn and transferred to materials
133ASTM F1108-97a, Standard Specification for Ti6A14V Alloy Castings for Surgical Implants (UNS R56406)Withdrawn and transferred to materials
134ASTM F1295-01, Standard Specification for Wrought Titanium-6 Aluminum-7 Niobium Alloy for Surgical Implant Applications (UNS R56700)Withdrawn and transferred to materials
135ASTM F1341-99, Standard Specification for Unalloyed Titanium Wire UNS R50250, UNS R50400, UNS R50500, UNS R50700, for Surgical Implant ApplicationsWithdrawn and transferred to materials
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136ASTM F1472-00, Standard Specification for Wrought Titanium-6 Aluminum-4 Vanadium Alloy (UNS R56400) for Surgical Implant ApplicationsWithdrawn and transferred to materials
137ASTM F1537-00, Standard Specification for Wrought Cobalt-28-Chromium-6-Molybdenum Alloy for Surgical Implants (UNS R31537, UNS R31538, and UNS R31539)Withdrawn and transferred to materials
138ASTM F1541-01, Standard Specification and Test Methods for External Skeletal Fixation DevicesWithdrawn and replaced with newer version158
139F1580-95e1, Standard Specification for Titanium and Titanium-6% Aluminum-4% Vanadium Alloy Powders for Coatings of Surgical ImplantsWithdrawn and transferred to materials
144ASTM F138-00, Standard Specification for Wrought 18 Chromium-14 Nickel-2.5 Molybdenum Stainless Bar and Wire for Surgical Implants (UNS S31673)Withdrawn and transferred to materials
146ASTM F603-00, Standard Specification for High-Purity Dense Aluminum Oxide for Surgical Implant ApplicationWithdrawn and transferred to materials
147ASTM F620-00, Standard Specification for Alpha Beta Titanium Alloy Forgings for Surgical ImplantsWithdrawn and transferred to materials
148ASTM F648-00, Standard Specification for Ultra-High-Molecular-Weight Polyethylene Powder and Fabricated Form for Surgical ImplantsWithdrawn and transferred to materials
149ASTM F746-87 (1999), Standard Test Method for Pitting or Crevice Corrosion of Metallic Surgical Implant MaterialsWithdrawn and transferred to materials
151ASTM F1091-91(2000), Standard Specification for Wrought Cobalt-20 Chromium-15 Tungsten-10 Nickel Alloy Surgical Fixation Wire (UNS R 30605)Withdrawn and transferred to Materials
154ASTM F1350-01, Standard Specification for Wrought 18 Chromium-14 Nickel-2.5, Molybdenum Stainless Steel Surgical Fixation Wire (UNS S31673)Withdrawn and transferred to materials

I. Physical Medicine

Old Item No.StandardChangeReplacement Item No.
21ISO 7176-6:2001, Wheelchairs—Part 6: Determination of Maximum Speed, Acceleration and Deceleration of Electric WheelchairsWithdrawn and replaced with newer version29
22ISO 7176-9:2001, Wheelchairs—Part 9: Climatic Tests for Electric WheelchairWithdrawn and replaced with newer version30

J. Radiology

Start Printed Page 61905
Old Item No.StandardChangeReplacement Item No.
9NEMA NU 1-2001, Performance Measurements of Scintillation CamerasWithdrawn and replaced with newer version75
18NEMA NU 2-2001, Performance Measurement of Positron Emission TomographsWithdrawn and replaced with newer version76
46AIUM RTD1—1998, Standard for Real-Time Display of Thermal and Mechanical Acoustic Output Indices on Diagnostic Ultrasound Equipment Revision 1Title correction46
61UL 122-2001, Standard for Safety of Photographic Equipment—Fourth EditionTitle correction61
62UL 187-1998, Standard for Safety X-ray Equipment—Seventh EditionTitle correction62
64IEC 60601-2-45, Ed. 2.0, Medical Electrical Equipment: Part 2-45: Particular Requirement for the Safety of Mammographic X-ray Equipment and Mammographic Stereotactic DevicesTitle correction64
66MUS (R 1999), Medical Ultrasound SafetyTitle correction66
67NEMA MS-1-2001, Determination of Signal to Noise Ratio (SNR) in Diagnostic Magnetic Resonance ImagesWithdrawn and replaced with newer version77
70NEMA PS 3.15 2000, Digital Imaging and Communication in Medicine (DICOM) Part 15: Security ProfileWithdrawn and replaced with newer version78
73UL-122 (R2001), Standard for Safety, Photographic EquipmentWithdrawn

K. Sterility

Old Item No.StandardChangeReplacement Item No.
01AOAC 6.2.01:1995, Official Method 955.24, Testing Disinfectants Against Salmonella choleraesuis, Use-Dilution MethodProduct codes01
02AOAC 6.2.02:1995, Official Method 991.47, Testing Disinfectants Against Salmonella choleraesuis, Hard Surface Carrier Test MethodProduct codes02
03AOAC 6.2.03:1995, Official Method 991.48, Testing Disinfectants Against Staphylococcus aureus, Hard Surface Carrier Test MethodProduct codes03
04AOAC 6.2.04:1995, Official Method 955.15, Testing Disinfectants Against Staphylococcus aureus, Use-Dilution MethodProduct codes04
Start Printed Page 61906
05AOAC 6.2.05:1995, Official Method 991.49, Testing Disinfectants Against Pseudomonas aeruginosa, Hard Surface Carrier Test MethodsProduct codes and relevant guidance05
06AOAC 6.2.06:1995, Official Method 964.02, Testing Disinfectants Against Pseudomonas aeruginosa, Use-Dilution MethodProduct codes and relevant guidance06
07AOAC 6.3.02:1995, Official Method 955.17, Fungicidal Activity of Disinfectants Using Trichophyton mentagrophytesProduct codes and relevant guidance07
08AOAC 6.3.05:1995, Official Method 966.04, Sporicidal Activity of DisinfectantsProduct codes and relevant guidance08
09AOAC 6.3.06:1995, Official Method 965.12, Tuberculocidal Activity of DisinfectantsProduct codes and relevant guidance09
10ANSI/AAMI ST8: 2001, Hospital Steam SterilizationWithdrawn and replaced with newer version71
11ANSI/AAMI ST19:1994, Biological Indicators for Saturated Steam SterilizationWithdrawn
12ANSI/AAMI ST21:1994, Biological Indicators for Ethylene Oxide Sterilization Processes in Health Care FacilitiesWithdrawn
14AAMI/ANSI ST33:1992, Guidance for the Selection and Use of Reusable Rigid Sterilization Container Systems for Ethylene Oxide Sterilization and Steam Sterilization in Health Care FacilitiesDevices affected72
19AAMI/ANSI ST46:1992, Good Hospital Practice Steam Sterilization and Sterility AssuranceDevices affected, correction to type of standard, and relevant guidance73
22ANSI/AAMI ST60:1996, Sterilization of Health Care Products—Chemical Indicators—Part 1: General RequirementsExtent of Recognition and relevant guidance74
25AAMI/ANSI/ISO 11135:1994, Medical Devices—Validation and Routine Control of Ethylene Oxide SterilizationRelevant guidance25
26AAMI/ANSI/ISO 11137:1994, Sterilization of Health Care Products—Requirements for Validation and Routine Control-Radiation Sterilization and ISO 11137:1995 (AMENDMENT 1:2001)Withdrawn and replaced with newer version, relevant guidance75
37AAMI/ANSI/ISO 10993-7:1995(R) 2001, Biological evaluation of medical devices—Part 7: Ethylene oxide sterilization residualsWithdrawn and replaced with newer version, relevant guidance76
38ANSI/AAMI ST24:1999, Automatic General Purpose Ethylene Oxide Sterilizers and Ethylene Oxide Sterilant Sources Intended for Use in Health Care FacilitiesDevices affected and type of standard77
39USP 25:2002, Biological Indicator for Dry-Heat Sterilization Paper CarrierWithdrawn and replaced with newer version78
40USP 25:2002, Biological Indicator for Ethylene Oxide Sterilization, Paper CarrierWithdrawn and replaced with newer version79
41USP 25:2002, Biological Indicator for Steam Sterilization, Paper CarrierWithdrawn and replaced with newer version80
42USP 25:2002, <61> Microbial Limits TestWithdrawn and replaced with newer version81
Start Printed Page 61907
43USP 25:2002, Sterility Test <71>Withdrawn and replaced with newer version82
44USP 25:2002, <85>, Biological Tests and Assays, Bacterial Endotoxin Test (LAL)Withdrawn and replaced with newer version83
45USP:2002 <151> Pyrogen Test (USP Rabbit Test)Withdrawn and replaced with newer version84
46USP:2002 <1211> Sterilization and Sterility Assurance of Compendial ArticlesWithdrawn and replaced with newer version85
49AAMI/ANSI ST41:1999, Ethylene Oxide Sterilization in Health Care Facilities: Safety and EffectivenessCitations, product codes and relevant guidance49
52ANSI/AAMI ST59:1999, Sterilization of Health Care Products—Biological Indicators Part 1: General RequirementsRelevant guidance52
53AAMI/ANSI ST 66:1999, Sterilization of Health Care Products—Chemical Indicators—Part 2: Class 2 Indicators for Air Removal Test Sheets and PacksRelevant guidance53
65ASTM F1980:2002, Standard Guide for Accelerated Aging of Sterile Medical Device PackagesWithdrawn and replaced with newer version86
66USP 25:2002, <161> Transfusion and Infusion Assemblies and Similar Medical DevicesWithdrawn and replaced with newer version87

III. Listing of New Entries

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

A. Biocompatibility

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

B. Cardiovascular/Neurology

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

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

Start Printed Page 61908
Item No.Title of StandardReference No. and Date
92Dental Brazing AlloysANSI/ADA Specification No. 88:2000
93Methods of Measurement of Compatibility Between Wireless Communication Devices and Hearing AidsANSI C63.19:2001

D. General Hospital/General Plastic Surgery

Item No.Title of StandardReference No. and Date
93Sterlie Water for IrrigationUSP 25
94Heparin Lock Flush SolutionUSP 25
95Sodium Chloride InjectionUSP 25
96Standard Test Method for Evaluating the Bacterial Filtration Efficiency (BFE) of Medical Face Mask Materials, Using a Biological Aerosol of Staphylococcus aureusASTM F2101-01

E. In Vitro Devices

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

F. Materials

Item No.Title of StandardReference No. and Date
09Standard Specification for Wrought Cobalt-20 Nickel-20 Chromium-3.5 Molybdenum-3.5 Tungsten-5 Iron Alloy for Surgical Implant Applications (UNS R30563)ASTM F563-00
37Standard Specification for Wrought Titanium-12 Molybdenum-6 Zirconium-2 Iron Alloy for Surgical Implant (UNS R58120)ASTM F1813-01
38Standard Terminology for Nickel-Titanium Shape Memory AlloysASTM F2005-00
40Standard Specification for Wrought Nickel-Titanium Shape Memory Alloys for Medical Devices and Surgical ImplantsASTM F2063-00
41Standard Specification for Wrought Titanium-15 Molybdenum Alloy for Surgical Implant Applications (UNS R58150)ASTM F2066-01
42Standard Test Method for Evaluation of MR Image Artifacts from Passive ImplantsASTM F2119-01
43Standard Specification for Wrought Titanium-3 Aluminum-2.5 Vanadium Alloy Seamless Tubing for Surgical Implant Applications (UNS R56320)ASTM F2146-01
Start Printed Page 61909

G. OB-GYN/Gastroenterology

Item No.Title of StandardReference No. and Date
26Natural Latex Rubber Condoms—Requirements and Test methodsISO 4074:2000(E)
27Standard Test Methods for Male Condoms Made from Synthetic MaterialsASTM D6324-99a

H. Ophthalmic

Item No.Title of StandardReference No. and Date
30Intraocular LensesANSI Z80.7:2001

I. Radiology

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

J. Sterility

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

Start Signature

Dated: September 18, 2002.

Linda S. Kahan,

Deputy Director, Center for Devices and Radiological Health.

End Signature End Supplemental Information

[FR Doc. 02-24954 Filed 10-1-02; 8:45 am]

BILLING CODE 4160-01-S