FDA Modernization Act of 1997: Modifications to the List of Recognized Standards, Recognition List Number: 007
Federal RegisterOct 2, 2002
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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
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:
• 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.
Standard
Change
Replacement Item No.
12
ASTM F813-01, Standard Practice for Direct Contact Cell Culture Evaluation of Materials for Medical Devices
Withdrawn and replaced with newer version 56
13
ASTM E895-84 (2001)e1, Standard Test Method for Agar Diffusion Cell Culture Screening for Cytotoxicity
Withdrawn and replaced with newer version
57
46
USP 25—NF20, Biological Tests <87>, Biological Reactivity Test, In Vitro—Direct Contact Test
Withdrawn and replaced with newer version
58
47
USP 25—NF20, Biological Tests <88>, Biological Reactivity Test, In Vitro—Elution Test
Withdrawn and replaced with newer version
59
48
USP 25—NF20, Biological Tests <88>, Biological Reactivity Test, In Vivo, Classification of Plastics—Simple Preparation
Withdrawn and replaced with newer version
60
49
USP 25—NF20, Biological Tests <88>, Biological Reactivity Test, In Vivo—Intracutaneous Test
Withdrawn and replaced with newer version
61
50
USP 25—NF20, Biological Tests <88>, Biological Reactivity Test, In Vivo—Systemic Injection Test
Withdrawn and replaced with newer version
62
55
ANSI/AAMI/ISO 10993-6:1995/(R)2001: Biological evaluation of medical devices—Part 6: Test for local effects after implantation
Withdrawn and replaced with newer version
63
54
ANSI/AAMI/ISO 10993-5: Biological evaluation of medical devices—Part 5: Tests for in vitro cytotoxicity
Withdrawn and replaced with change in extent of recognition
64
B. Cardiovascular/Neurology
Old Item No.
Standard
Change
Replacement Item No.
12
ASTM F961-96, Standard Specification for Cobalt-35 Nickel-20 Chromium-10 Molybdenum Alloy Forgings for Surgical Implants [UNS R30035]
Withdrawn and transferred to materials
21
ASTM 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
22
ASTM 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
24
ASTM F560-98, Standard Specification for Unalloyed Tantalum for Surgical Implant Applications (UNS R05200, UNS R05400)
Withdrawn and transferred to materials
28
ASTM F1058-97, Standard Specification for Wrought Cobalt-Chromium-Nickel-Molybdenum-Iron Alloy for Surgical Implant Applications
Withdrawn and transferred to materials
34
ASTM 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
35
ASTM F562-00, Standard Specification for Wrought Cobalt-35 Nickel-20 Chromium-10 Molybdenum Alloy for Surgical Implant Applications
Withdrawn and transferred to materials
36
ASTM F136-98e1, Standard Specification for Wrought Titanium-6 Aluminum-4 Vanadium ELI (Extra Low Interstitial) Alloy (UNS R56401) for Surgical Implant Applications
Withdrawn and transferred to materials
C. Dental/ENT
Old Item No.
Standard
Change
Replacement Item No.
01
ASTM F67-00, Standard Specification for Unalloyed Titanium for Surgical Implant Applications (UNS R50250, UNS R50550, UNS R50700)
Withdrawn and transferred to materials
02
ASTM 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
03
ASTM 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
04
ASTM F136-98e1, Standard Specification for Wrought Titanium-6 Aluminum-4 Vanadium ELI (Extra Low Interstitial) Alloy (UNS R56401) for Surgical Implant Applications
Withdrawn and transferred to materials
05
ASTM 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
06
ASTM 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
07
ASTM F562-00, Standard Specification for Wrought Cobalt-35 Nickel-20 Chromium-10 Molybdenum Alloy for Surgical Implant Applications
Withdrawn and transferred to materials
08
ASTM F620-00, Standard Specification for Alpha Beta Titanium Alloy Forgings for Surgical Implants
Withdrawn and transferred to materials
09
ASTM F621-97, Standard Specification for Stainless Steel Forgings for Surgical Implants
Withdrawn and transferred to materials
10
ASTM 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
11
ASTM F745-00, Standard Specification for 18 Chromium-12.5 Nickel-2.5 Molybdenum Stainless Steel for Cast and Solution-Annealed Surgical Implant Applications
Withdrawn and transferred to materials
12
ASTM F799-99, Standard Specification for Cobalt-28 Chromium-6 Molybdenum Alloy Forgings for Surgical Implants (UNS R31537, R31538, R31539)
Withdrawn and transferred to materials
13
ASTM F961-96, Standard Specification for Cobalt-35 Nickel-20 Chromium-10 Molybdenum Alloy Forgings for Surgical Implants [UNS R30035]
Withdrawn and transferred to materials
14
ASTM F1088-87 (1992)e1, Standard Specification for Beta-Tricalcium Phosphate for Surgical Implantation
Withdrawn and transferred to materials
15
ASTM 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
16
ASTM F1108-97a, Standard Specification for Ti6A14V Alloy Castings for Surgical Implants (UNS R56406)
Withdrawn and transferred to materials
17
ASTM F1185-88(1993)e1, Standard Specification for Composition of Ceramic Hydroxylapatite for Surgical Implants
Withdrawn and transferred to materials
18
ASTM F1295-01, Standard Specification for Wrought Titanium-6 Aluminum-7 Niobium Alloy for Surgical Implant Applications (UNS R56700)
Withdrawn and transferred to materials
19
ASTM 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
20
ASTM F1341-99, Standard Specification for Unalloyed Titanium Wire UNS R50250, UNS R50400, UNS R50500, UNS R50700, for Surgical Implant Applications
Withdrawn and transferred to materials
21
ASTM 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
23
ASTM F1472-00, Standard Specification for Wrought Titanium-6 Aluminum-4 Vanadium Alloy (UNS R56400) for Surgical Implant Applications
Withdrawn and transferred to materials
24
ASTM 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
25
F1580-95e1, Standard Specification for Titanium and Titanium-6% Aluminum-4% Vanadium Alloy Powders for Coatings of Surgical Implants
Withdrawn and transferred to materials
26
ASTM 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
27
ASTM F1609-95, Standard Specification for Calcium Phosphate Coatings for Implantable materials
Withdrawn and transferred to materials
28
ASTM F1713-96, Standard Specification for Wrought Titanium-13 Niobium-13 Zirconium Alloy for Surgical Implant Applications
Withdrawn and transferred to materials
42
ANSI/ADA Specification No. 3:1994, Dental Impression Compound
Contact person
42
44
ANSI/ADA Specification No. 11:1968, Agar Impression Material
Contact person
44
45
ANSI/ADA Specification No. 13:1981, Denture Cold-Curing Repair Resin
Contact person
45
48
ANSI/ADA Specification No. 16:1989, Dental Impression Paste Zinc Oxide Eugenol Type
Contact person
48
49
ANSI/ADA Specification No. 17:1983, Denture Base Temporary Relining Resin
Contact person
49
50
ANSI/ADA Specification No. 18:1992, Alginate Impression Materials
Contact person
50
51
ANSI/ADA Specification No. 20:1968, Dental Duplicating Material
Contact person
51
52
ANSI/ADA Specification No. 27:1993, Resin-Based Filling Materials
Contact person
52
53
ANSI/ADA Specification No. 30:1990, Dental Zinc Oxide-Eugenol and Zinc Oxide Non-Eugenol Cements
Contact person
53
55
ANSI/ADA Specification No. 48:1983, Ultraviolet Activator and Disclosing Lights
Contact person, update to processes impacted to include quality system regulation
55
56
ANSI/ADA Specification No. 57:1993, Endodontic Sealing Materials
Contact person, update to processes impacted to include quality system regulation
56
59
ANSI/ADA Specification No. 80:2001, Color Stability Test Procedures
Withdrawn and replaced with newer version, update to processes impacted to include quality system regulation
91
60
ANSI/ADA Specification No. 96:1994, Dental-Water-Based Cements
Contact person, update to processes impacted to include quality system regulation
60
62
ISO 1563:1990, Dental Alginate Impression Material
Contact person, update to processes impacted to include quality system regulation
62
63
ISO 1564:1995, Dental Aqueous Impression Materials Based on Agar
Contact person, update to processes impacted to include quality system regulation
63
64
ISO 3107:1998, Dental Zinc Oxide Eugenol Cements and Zinc Oxide Non-Eugenol Cements
Contact person, update to processes impacted to include quality system regulation
64
65
ISO 3336:1993, Dentistry—Synthetic Polymer Teeth
Contact person, update to processes impacted to include quality system regulation
65
66
ISO 4049:1998, Dentistry—Resin-Based Filling Materials
Contact person, update to processes impacted to include quality system regulation
66
69
ISO 6872:1995, Amendment 1-1997 Dental Ceramic
Contact person, update to processes impacted to include quality system regulation
69
71
ISO 6876:1986, Dental Root Canal Sealing Materials
Contact person, update to processes impacted to include quality system regulation
71
72
ISO 6877:1995, Dental Root Canal Obturating Points
Contact person, update to processes impacted to include quality system regulation
72
80
ISO 9917:1991, Dental Water-Based Cements
Contact person, update to processes impacted to include quality system regulation
80
81
ISO 10139-1:1991, Dentistry—Resilient Lining Materials for Removable Dentures Part 1: Short Term Materials
Contact person, Update to CDRH Offices to include OC/DE2, and update to processes impacted to include quality system regulation
81
82
ISO 10477:1998, Dentistry—Polymer-Based Crown and Bridge Materials
Contact person, update to processes impacted to include quality system regulation
82
85
ANSI/ADA Specification 15:1999, Synthetic Resin Teeth
Contact person, update to processes impacted to include quality system regulation
85
86
ANSI/ADA Specification No. 38:2000, Metal-Ceramic System
Contact person, update to processes impacted to include quality system regulation
86
87
ANSI/ADA Specification No. 69:1999, Dental Ceramic
Contact person, update to processes impacted to include quality system regulation
87
88
ANSI/ADA Specification No. 78:2000, Endodontic Obturating Points
Contact person
88
89
ANSI/ASA Specification No. 53:1999, Polymer-Based Crown and Bridge Resins
Contact Person, update to processes impacted to include quality system regulation
89
D. General
Old Item No.
Standard
Change
Replacement Item No.
28
IEC 60601-1-2 (Second Edition, 2001), Medical Electrical Equipment—Part1: General Requirements for Safety; Electomagnetic Compatibility—Requirements and Tests
Transition statement added to the extent of recognition
28
E. General Hospital/General Plastic Surgery
Old Item No.
Standard
Change
Replacement Item No.
13
ISO 595/1 First Edition 1986-12-15, Reusable All Glass or Metal-and-Glass Syringes for Medical Use, Part 1: Dimensions
Citations and product codes
13
49
ASTM D6355-98, Standard Test Method for Human Repeat Insult Patch Testing of Medical Gloves
Withdrawn
57
USP 24 <11>, Sterile Water for Injection
Withdrawn
62
ISO 8536-6, First Edition, 1996-04-01, Infusion Equipment for Medical Use—Part 6: Freeze Drying Closures for Infusion Bottles
Citations and product codes
62
63
ISO 8536-7, Second Edition, 1999-09-01, Infusion Equipment, Caps made of Aluminum-Plastic Combinations for Infusion Bottles
Citations and product codes
63
76
ISO 1135-4, Second Edition, 1998-03-15, Transfusion Equipment for Medical Use—Part 4: Transfusion Sets for Single Use
Citations and product codes
76
80
ASTM E1112-00, Standards Specification for Electronic Thermometers for Intermittent Determinations of Patient Temperatures
Contact person
80
41
USP 25, Nonabsorbable Surgical Sutures
Withdrawn and replaced with newer version
82
50
ASTM D6319-00ae3, Standard Specification for Nitrile Examination Gloves for Medical Application
Withdrawn and replaced with newer version
83
51
ASTM D6124-01, Standard Test Method for Residual Powder on Medical Globes
Withdrawn and replaced with newer version
84
52
ASTM D5250-00e4, Standard Specification for Poly (vinyl chloride) Gloves for Medical Application
Withdrawn and replaced with newer version
85
54
ASTM D3578-01ae2, Standard Specification for Rubber Examination Gloves
Withdrawn and replaced with newer version
86
55
ASTM D3577-01ae2, Standard Specification for Rubber Surgical Gloves
Withdrawn and replaced with newer version
87
56
USP 25 <11>, Sterile Sodium Chloride for Irrigation
Withdrawn and replaced with newer version
88
58
USP 25, Absorbable Surgical Sutures
Withdrawn and replaced with newer version
89
59
USP 25 <881>, Tensile Strength
Withdrawn and replaced with newer version
90
60
USP 25 <861>, Sutures—Diameter
Withdrawn and replaced with newer version
91
61
USP 25 <871>, Sutures Needle Attachment
Withdrawn and replaced with newer version
92
F. Materials
Old Item No.
Standard
Change
Replacement Item No.
Dental 01, Ortho 123
ASTM F67-00, Standard Specification for Unalloyed Titanium for Surgical Implant Applications (UNS R50250, UNS R50550, UNS R 50700)
Transferred from dental/ENT and orthopaedics
01
Cardio 21, Dental 02, Ortho 86
ASTM 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 orthopaedics
02
Cardio 22, Dental 03, Ortho 87
ASTM 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 orthopaedics
03
Cardio 36, Dental 04, Ortho 88
ASTM F136-98e1, Standard Specification for Wrought Titanium-6 Aluminum-4 Vanadium ELI (Extra Low Interstitial) Alloy (UNS R56401) for Surgical Implant Applications
Transferred from cardiovascular/neurology, dental/ENT and orthopaedics
04
Cardio 34, Dental 05, Ortho 144
ASTM 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 orthopaedics
05
Dental 06, Ortho 125
ASTM 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 orthopaedics
06
Cardio 24, Ortho 90
ASTM F560-98, Standard Specification for Unalloyed Tantalum for Surgical Implant Applications (UNS R05200, UNS R05400)
Transferred from cardiovascular/neurology and orthopaedics
07
Cardio 35, Dental 07, Ortho 127
ASTM F562-00, Standard Specification for Wrought Cobalt-35 Nickel-20 Chromium-10 Molybdenum Alloy for Surgical Implant Applications
Transferred from cardiovascular/neurology, dental/ENT and orthopaedics
08
Ortho 146
ASTM F603-00, Standard Specification for High-Purity Dense Aluminum Oxide for Surgical Implant Application
Transferred from orthopaedics
10
Dental 08, Ortho 147
ASTM F620-00, Standard Specification for Alpha Beta Titanium Alloy Forgings for Surgical Implants
Transferred from dental/ENT and orthopaedics
11
Dental 09, Ortho 97
ASTM F621-97, Standard Specification for Stainless Steel Forgings for Surgical Implants
Transferred from dental/ENT and orthopaedics
12
Ortho 148
ASTM F648-00, Standard Specification for Ultra-High-Molecular-Weight Polyethylene Powder and Fabricated Form for Surgical Implants
Transferred from orthopaedics
13
Dental 10, Ortho 128
ASTM 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 orthopaedics
14
Dental 11, Ortho 129
ASTM F745-00, Standard Specification for 18 Chromium-12.5 Nickel-2.5 Molybdenum Stainless Steel for Cast and Solution-Annealed Surgical Implant Applications
Transferred from dental/ENT and orthopaedics
15
Ortho 149
ASTM F746-87 (1999), Standard Test Method for Pitting or Crevice Corrosion of Metallic Surgical Implant Materials
Transferred from orthopaedics
16
Dental 12, Ortho 130
ASTM F799-99, Standard Specification for Cobalt-28 Chromium-6 Molybdenum Alloy Forgings for Surgical Implants (UNS R31537, R31538, R31539)
Transferred from dental/ENT and orthopaedics
17
Ortho 27
ASTM F899-95, Standard Specification for Stainless Steel Billet, Bar, and Wire for Surgical Instruments
Transferred from orthopaedics
18
Cardio 12, Dental 13, Ortho 28
ASTM 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 orthopaedics
19
Cardio 28
ASTM F1058-97, Standard Specification for Wrought Cobalt-Chromium-Nickel-Molybdenum-Iron Alloy for Surgical Implant Applications
Transferred from cardiovascular/neurology
20
Dental 14, Ortho 132
ASTM F1088-87 (1992)e1, Standard Specification for Beta-Tricalcium Phosphate for Surgical Implantation
Transferred from dental/ENT and orthopaedics
21
Dental 15, Ortho 151
ASTM 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 orthopaedics
22
Dental 16, Ortho 133
ASTM F1108-97a, Standard Specification for Ti6A14V Alloy Castings for Surgical Implants (UNS R56406)
Transferred from dental/ENT and orthopaedics
23
Dental 17, Ortho 109
ASTM F1185-88(1993)e1, Standard Specification for Composition of Ceramic Hydroxylapatite for Surgical Implants
Transferred from dental/ENT and orthopaedics
24
Dental 18, Ortho 134
ASTM F1295-01, Standard Specification for Wrought Titanium-6 Aluminum-7 Niobium Alloy for Surgical Implant Applications (UNS R56700)
Transferred from dental/ENT and orthopaedics
25
Dental 19, Ortho 40
ASTM 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 orthopaedics
26
Dental 20, Ortho 135
ASTM F1341-99, Standard Specification for Unalloyed Titanium Wire UNS R50250, UNS R50400, UNS R50500, UNS R50700, for Surgical Implant Applications
Transferred for dental/ENT and orthopaedics
27
Dental 21, Ortho 154
ASTM 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 orthopaedics
28
Dental 23, Ortho 136
ASTM F1472-00, Standard Specification for Wrought Titanium-6 Aluminum-4 Vanadium Alloy (UNS R56400) for Surgical Implant Applications
Transferred from dental/ENT and orthopaedics
29
Dental 24, Ortho 137
ASTM 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 orthopaedics
30
Dental 25, Ortho 139
ASTM F1580-95e1, Standard Specification for Titanium and Titanium-6% Aluminum-4% Vanadium Alloy Powders for Coatings of Surgical Implants
Transferred from dental/ENT and orthopaedics
31
Dental 26, Ortho 50
ASTM 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 orthopaedics
32
Dental 27, Ortho 51
ASTM F1609-95, Standard Specification for Calcium Phosphate Coatings for Implantable Materials
Transferred from dental/ENT and orthopaedics
33
Ortho 54
ASTM F1659-95, Standard Test Method for Bending and Shear Testing of Calcium Phosphate Coatings on Solid Metallic Substrates
Transferred from orthopaedics
34
Dental 28, Ortho 56
ASTM F1713-96, Standard Specification for Wrought Titanium-13 Niobium-13 Zirconium Alloy for Surgical Implant Applications
Transferred from dental /ENT and orthopaedics
35
Ortho 116
ASTM F1801-97, Standard Recommended Practice for Corrosion Fatigue Testing of Metallic Implant Materials
Transferred from orthopaedics
36
Rad 65
ASTM F2052-00, Standard Test Method for Measurement of Magnetically Induced Displacement Force on Passive Implants in the Magnetic Resonance Environment
Transferred from radiology
39
G. Obstetrics and Gynecology (OB-GYN)/Gastroenterology
Old Item No.
Standard
Change
Replacement Item No.
08
ISO 4047-1: 1996(E): Rubber Condoms—Part 1: Requirements
Withdrawn and replaced with newer version
26
09
ISO 4074-2: 1994(E): Rubber Condoms—Part 2: Determination of Length
Withdrawn and replaced with newer version
26
10
ISO 4047-3: 1994(E): Rubber Condoms—Part 3: Determination of Width
Withdrawn and replaced with newer version
26
11
ISO 4047-5: 1996(E): Rubber Condoms—Part 5: Testing for Holes—Water Leak Test
Withdrawn and replaced with newer version
26
12
ISO 4074-6: 1996(E): Rubber Condoms—Part 6: Determination of Bursting Volume and Pressure
Withdrawn and replaced with newer version
26
13
ISO 4074-7: 1996(E): Rubber Condoms—Part 7: Oven Conditioning
Withdrawn and replaced with newer version
26
14
ISO 4047-9: 1996(E): Rubber Condoms—Part 9: Determination of Tensile Properties
Withdrawn and replaced with newer version
26
H. Orthopaedics
Old Item No.
Standard
Change
Replacement Item No.
27
ASTM F899-95, Standard Specification for Stainless Steel Billet, Bar, and Wire for Surgical Instruments
Withdrawn and transferred to materials
28
ASTM F961-96, Standard Specification for Cobalt-35 Nickel-20 Chromium-10 Molybdenum Alloy Forgings for Surgical Implants [UNS R30035]
Withdrawn and Transferred to materials
40
ASTM 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
50
ASTM 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
51
ASTM F1609-95, Standard Specification for Calcium Phosphate Coatings for Implantable Materials
Withdrawn and Transferred to materials
54
ASTM F1659-95, Standard Test Method for Bending and Shear Testing of Calcium Phosphate Coatings on Solid Metallic Substrates
Withdrawn and Transferred to materials
56
ASTM F1713-96, Standard Specification for Wrought Titanium-13 Niobium-13 Zirconium Alloy for Surgical Implant Applications
Withdrawn and Transferred to materials
86
ASTM 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
87
ASTM 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
88
ASTM F136-98e1, Standard Specification for Wrought Titanium-6 Aluminum-4 Vanadium ELI (Extra Low Interstitial) Alloy (UNS R56401) for Surgical Implant Applications
Withdrawn and transferred to Materials
90
ASTM F560-98, Standard Specification for Unalloyed Tantalum for Surgical Implant Applications (UNS R05200, UNS R05400)
Withdrawn and Transferred to materials
97
ASTM F621-97, Standard Specification for Stainless Steel Forgings for Surgical Implants
Withdrawn and Transferred to materials
109
ASTM F1185-88(1993)e1, Standard Specification for Composition of Ceramic Hydroxylapatite for Surgical Implants
Withdrawn and transferred to Materials
116
ASTM F1801-97, Standard Recommended Practice for Corrosion Fatigue Testing of Metallic Implant Materials
Withdrawn and transferred to materials
123
ASTM F67-00, Standard Specification for Unalloyed Titanium for Surgical Implant Applications (UNS R50250, UNS R50550, UNS R 50700)
Withdrawn and transferred to materials
125
ASTM 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
127
ASTM F562-00, Standard Specification for Wrought Cobalt-35 Nickel-20 Chromium-10 Molybdenum Alloy for Surgical Implant Applications
Withdrawn and transferred to materials
128
ASTM 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
129
ASTM F745-00, Standard Specification for 18 Chromium-12.5 Nickel-2.5 Molybdenum Stainless Steel for Cast and Solution-Annealed Surgical Implant Applications
Withdrawn and transferred to materials
130
ASTM F799-99, Standard Specification for Cobalt-28 Chromium-6 Molybdenum Alloy Forgings for Surgical Implants (UNS R31537, R31538, R31539)
Withdrawn and transferred to Materials
132
ASTM F1088-87 (1992)e1, Standard Specification for Beta-Tricalcium Phosphate for Surgical Implantation
Withdrawn and transferred to materials
133
ASTM F1108-97a, Standard Specification for Ti6A14V Alloy Castings for Surgical Implants (UNS R56406)
Withdrawn and transferred to materials
134
ASTM F1295-01, Standard Specification for Wrought Titanium-6 Aluminum-7 Niobium Alloy for Surgical Implant Applications (UNS R56700)
Withdrawn and transferred to materials
135
ASTM F1341-99, Standard Specification for Unalloyed Titanium Wire UNS R50250, UNS R50400, UNS R50500, UNS R50700, for Surgical Implant Applications
Withdrawn and transferred to materials
136
ASTM F1472-00, Standard Specification for Wrought Titanium-6 Aluminum-4 Vanadium Alloy (UNS R56400) for Surgical Implant Applications
Withdrawn and transferred to materials
137
ASTM 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
138
ASTM F1541-01, Standard Specification and Test Methods for External Skeletal Fixation Devices
Withdrawn and replaced with newer version
158
139
F1580-95e1, Standard Specification for Titanium and Titanium-6% Aluminum-4% Vanadium Alloy Powders for Coatings of Surgical Implants
Withdrawn and transferred to materials
144
ASTM 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
146
ASTM F603-00, Standard Specification for High-Purity Dense Aluminum Oxide for Surgical Implant Application
Withdrawn and transferred to materials
147
ASTM F620-00, Standard Specification for Alpha Beta Titanium Alloy Forgings for Surgical Implants
Withdrawn and transferred to materials
148
ASTM F648-00, Standard Specification for Ultra-High-Molecular-Weight Polyethylene Powder and Fabricated Form for Surgical Implants
Withdrawn and transferred to materials
149
ASTM F746-87 (1999), Standard Test Method for Pitting or Crevice Corrosion of Metallic Surgical Implant Materials
Withdrawn and transferred to materials
151
ASTM 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
154
ASTM 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.
Standard
Change
Replacement Item No.
21
ISO 7176-6:2001, Wheelchairs—Part 6: Determination of Maximum Speed, Acceleration and Deceleration of Electric Wheelchairs
Withdrawn and replaced with newer version
29
22
ISO 7176-9:2001, Wheelchairs—Part 9: Climatic Tests for Electric Wheelchair
Withdrawn and replaced with newer version
30
J. Radiology
Old Item No.
Standard
Change
Replacement Item No.
9
NEMA NU 1-2001, Performance Measurements of Scintillation Cameras
Withdrawn and replaced with newer version
75
18
NEMA NU 2-2001, Performance Measurement of Positron Emission Tomographs
Withdrawn and replaced with newer version
76
46
AIUM RTD1—1998, Standard for Real-Time Display of Thermal and Mechanical Acoustic Output Indices on Diagnostic Ultrasound Equipment Revision 1
Title correction
46
61
UL 122-2001, Standard for Safety of Photographic Equipment—Fourth Edition
Title correction
61
62
UL 187-1998, Standard for Safety X-ray Equipment—Seventh Edition
Title correction
62
64
IEC 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 Devices
Title correction
64
66
MUS (R 1999), Medical Ultrasound Safety
Title correction
66
67
NEMA MS-1-2001, Determination of Signal to Noise Ratio (SNR) in Diagnostic Magnetic Resonance Images
Withdrawn and replaced with newer version
77
70
NEMA PS 3.15 2000, Digital Imaging and Communication in Medicine (DICOM) Part 15: Security Profile
Withdrawn and replaced with newer version
78
73
UL-122 (R2001), Standard for Safety, Photographic Equipment
Withdrawn
K. Sterility
Old Item No.
Standard
Change
Replacement Item No.
01
AOAC 6.2.01:1995, Official Method 955.24, Testing Disinfectants Against Salmonella choleraesuis, Use-Dilution Method
Product codes
01
02
AOAC 6.2.02:1995, Official Method 991.47, Testing Disinfectants Against Salmonella choleraesuis, Hard Surface Carrier Test Method
Product codes
02
03
AOAC 6.2.03:1995, Official Method 991.48, Testing Disinfectants Against Staphylococcus aureus, Hard Surface Carrier Test Method
Product codes
03
04
AOAC 6.2.04:1995, Official Method 955.15, Testing Disinfectants Against Staphylococcus aureus, Use-Dilution Method
Product codes
04
05
AOAC 6.2.05:1995, Official Method 991.49, Testing Disinfectants Against Pseudomonas aeruginosa, Hard Surface Carrier Test Methods
Product codes and relevant guidance
05
06
AOAC 6.2.06:1995, Official Method 964.02, Testing Disinfectants Against Pseudomonas aeruginosa, Use-Dilution Method
Product codes and relevant guidance
06
07
AOAC 6.3.02:1995, Official Method 955.17, Fungicidal Activity of Disinfectants Using Trichophyton mentagrophytes
Product codes and relevant guidance
07
08
AOAC 6.3.05:1995, Official Method 966.04, Sporicidal Activity of Disinfectants
Product codes and relevant guidance
08
09
AOAC 6.3.06:1995, Official Method 965.12, Tuberculocidal Activity of Disinfectants
Product codes and relevant guidance
09
10
ANSI/AAMI ST8: 2001, Hospital Steam Sterilization
Withdrawn and replaced with newer version
71
11
ANSI/AAMI ST19:1994, Biological Indicators for Saturated Steam Sterilization
Withdrawn
12
ANSI/AAMI ST21:1994, Biological Indicators for Ethylene Oxide Sterilization Processes in Health Care Facilities
Withdrawn
14
AAMI/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 Facilities
Devices affected
72
19
AAMI/ANSI ST46:1992, Good Hospital Practice Steam Sterilization and Sterility Assurance
Devices affected, correction to type of standard, and relevant guidance
73
22
ANSI/AAMI ST60:1996, Sterilization of Health Care Products—Chemical Indicators—Part 1: General Requirements
Extent of Recognition and relevant guidance
74
25
AAMI/ANSI/ISO 11135:1994, Medical Devices—Validation and Routine Control of Ethylene Oxide Sterilization
Relevant guidance
25
26
AAMI/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 guidance
75
37
AAMI/ANSI/ISO 10993-7:1995(R) 2001, Biological evaluation of medical devices—Part 7: Ethylene oxide sterilization residuals
Withdrawn and replaced with newer version, relevant guidance
76
38
ANSI/AAMI ST24:1999, Automatic General Purpose Ethylene Oxide Sterilizers and Ethylene Oxide Sterilant Sources Intended for Use in Health Care Facilities
Devices affected and type of standard
77
39
USP 25:2002, Biological Indicator for Dry-Heat Sterilization Paper Carrier
Withdrawn and replaced with newer version
78
40
USP 25:2002, Biological Indicator for Ethylene Oxide Sterilization, Paper Carrier
Withdrawn and replaced with newer version
79
41
USP 25:2002, Biological Indicator for Steam Sterilization, Paper Carrier
Withdrawn and replaced with newer version
80
42
USP 25:2002, <61> Microbial Limits Test
Withdrawn and replaced with newer version
81
43
USP 25:2002, Sterility Test <71>
Withdrawn and replaced with newer version
82
44
USP 25:2002, <85>, Biological Tests and Assays, Bacterial Endotoxin Test (LAL)
Withdrawn and replaced with newer version
83
45
USP:2002 <151> Pyrogen Test (USP Rabbit Test)
Withdrawn and replaced with newer version
84
46
USP:2002 <1211> Sterilization and Sterility Assurance of Compendial Articles
Withdrawn and replaced with newer version
85
49
AAMI/ANSI ST41:1999, Ethylene Oxide Sterilization in Health Care Facilities: Safety and Effectiveness
Citations, product codes and relevant guidance
49
52
ANSI/AAMI ST59:1999, Sterilization of Health Care Products—Biological Indicators Part 1: General Requirements
Relevant guidance
52
53
AAMI/ANSI ST 66:1999, Sterilization of Health Care Products—Chemical Indicators—Part 2: Class 2 Indicators for Air Removal Test Sheets and Packs
Relevant guidance
53
65
ASTM F1980:2002, Standard Guide for Accelerated Aging of Sterile Medical Device Packages
Withdrawn and replaced with newer version
86
66
USP 25:2002, <161> Transfusion and Infusion Assemblies and Similar Medical Devices
Withdrawn and replaced with newer version
87
III. Listing of New Entries
FDA is adding new entries to the list of recognized standards as follows:
A. Biocompatibility
Item No.
Title of Standard
Reference No. and Date
65
Standard Practice for Testing for Alternative Pathway Complement Activation in Serum by Solid Materials
ASTM F2065-00
66
Standard Practice for Evaluation of Delayed Contact Hypersensitivity Using the Murine Local Lymph Node Assay (LLNA)
ASTM F2148-01
67
Standard Practice for Assessment of Hemolytic Properties of Materials
ASTM F756-00
B. Cardiovascular/Neurology
Item No.
Title of Standard
Reference No. and Date
45
Testing and Reporting Performance Results of Cardiac Rhythm and ST-Segment Measurement Algorithms
ANSI/AAMI EC57-98
46
Standard Test Method for Measuring Recoil of Balloon-Expandable Stents
ASTM F2079-00
47
Standard Guide for Characterization and Presentation of the Dimensional Attributes of Vascular Stents
ASTM F2081-02
48
Test Method for Conducting Cyclic Potentiodynamic Polarization Measurements to Determine the Corrosion Susceptibility of Small Implant Devices
ASTM F2129-01
C. Dental/Ear, Nose, and Throat (ENT)
Item No.
Title of Standard
Reference No. and Date
92
Dental Brazing Alloys
ANSI/ADA Specification No. 88:2000
93
Methods of Measurement of Compatibility Between Wireless Communication Devices and Hearing Aids
ANSI C63.19:2001
D. General Hospital/General Plastic Surgery
Item No.
Title of Standard
Reference No. and Date
93
Sterlie Water for Irrigation
USP 25
94
Heparin Lock Flush Solution
USP 25
95
Sodium Chloride Injection
USP 25
96
Standard Test Method for Evaluating the Bacterial Filtration Efficiency (BFE) of Medical Face Mask Materials, Using a Biological Aerosol of Staphylococcus aureus
ASTM F2101-01
E. In Vitro Devices
Item No.
Title of Standard
Reference No. and Date
62
Laboratory Automation: Systems Operational Requirements, Characteristics, and Information Elements; Approved Standard
NCCLS: AUTO04-A
63
Laboratory Automation: Electromechanical Interfaces; Approved Standard
NCCLS: AUTO05-A
64
Point-of-Care Connectivity; Approved Standard
NCCLS: POCT1-A
F. Materials
Item No.
Title of Standard
Reference No. and Date
09
Standard 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
37
Standard Specification for Wrought Titanium-12 Molybdenum-6 Zirconium-2 Iron Alloy for Surgical Implant (UNS R58120)
ASTM F1813-01
38
Standard Terminology for Nickel-Titanium Shape Memory Alloys
ASTM F2005-00
40
Standard Specification for Wrought Nickel-Titanium Shape Memory Alloys for Medical Devices and Surgical Implants
ASTM F2063-00
41
Standard Specification for Wrought Titanium-15 Molybdenum Alloy for Surgical Implant Applications (UNS R58150)
ASTM F2066-01
42
Standard Test Method for Evaluation of MR Image Artifacts from Passive Implants
ASTM F2119-01
43
Standard Specification for Wrought Titanium-3 Aluminum-2.5 Vanadium Alloy Seamless Tubing for Surgical Implant Applications (UNS R56320)
ASTM F2146-01
G. OB-GYN/Gastroenterology
Item No.
Title of Standard
Reference No. and Date
26
Natural Latex Rubber Condoms—Requirements and Test methods
ISO 4074:2000(E)
27
Standard Test Methods for Male Condoms Made from Synthetic Materials
ASTM D6324-99a
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 Cables and Receptacles
NEMA XR 7-1995 (R2000)
80
Power Supply Guidelines for X-ray Machines
NEMA XR 9-1984 (R1994, R2000)
81
Mechanical Safety Standard for Power Driven Motions of Electromedical Equipment
NEMA XR 13-1990 (R1995, R2000)
82
Recommended Practices for Load Bearing Mechanical Assemblies Used in Diagnostic Imaging
NEMA XR 14-1990 (R1995, R2000)
83
Medical Electrical Equipment, Part 2-37: Particular Requirements for the Safety of Ultrasonic Medical Diagnostic and Monitoring Equipment
IEC 60601-2-37 (2001-07)
84
Consol. Ed. 1.2 (incl. am1+am2), Safety of Laser Products—Part 1: Equipment Classification, Requirements and User's Guide
IEC 60825-1 (2001-08)
85
Ed. 2.0, Medical Electrical Equipment—Part 2: Particular Requirements for the Safety of Diagnostic and Therapeutic Laser Equipment
IEC 60601-2-22 (1995-11)
J. Sterility
Item No.
Title of Standard
Reference No. and Date
88
Sterilization 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 Devices
ANSI/AAMI/ISO 14937:2000
89
Standard Test Method for Burst Testing of Flexible Package Seals Using Internal Air Pressurization Within Restraining Plates
ASTM F2054-00
90
Standard Test Methods for Pressure Decay Leak Test for Nonporous Flexible Packages With and Without Restraining Plates
ASTM F2095-01
91
Standard Test Method for Detecting Gross Leaks in Porous Medical Packaging by Internal Pressurization (Bubble Test)
ASTM F2096-1
92
Standard Guide for Design and Evaluation of Primary Packaging for Medical Products
ASTM F2097-01
93
Biological Indicator for Steam Sterilization—Self Contained
USP 25:2002
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.”
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
This is a copy of a public record, reproduced as it was published. It is not legal advice, and it may not be the version a court would rely on. Check the official source before you cite it.