Food and Drug Administration Modernization Act of 1997: Modifications to the List of Recognized Standards, Recognition List Number: 014

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 2004N-0226]

Food and Drug Administration Modernization Act of 1997: Modifications to the List of Recognized Standards, Recognition List Number: 014

AGENCY:

Food and Drug Administration, HHS.

ACTION:

Notice.

SUMMARY:

The Food and Drug Administration (FDA) is announcing a publication containing modifications the agency is making to the list of standards FDA recognizes for use in premarket reviews (FDA recognized consensus standards). This publication, entitled “Modifications to the List of Recognized Standards, Recognition List Number: 014” (Recognition List Number: 014), will assist manufacturers who elect to declare conformity with consensus standards to meet certain requirements for medical devices.

DATES:

Submit written or electronic comments concerning this document at any time. See section VII of this document for the effective date of the recognition of standards announced in this document.

ADDRESSES:

Submit written requests for single copies of “Modifications to the List of Recognized Standards, Recognition List Number: 014” to the Division of Small Manufacturers, International and Consumer Assistance, Center for Devices and Radiological Health (HFZ-220), Food and Drug Administration, 1350 Piccard Dr., Rockville, MD 20850. Send two self-addressed adhesive labels to assist that office in processing your requests, or fax your request to 301-443-8818. Submit written comments concerning this document, or recommendations for additional standards for recognition, to the contact person (see

FOR FURTHER INFORMATION CONTACT

). Submit electronic comments by e-mail:

standards@cdrh.fda.hhs.gov

. This document may also be accessed on FDA's Web site at

http://www.fda.gov/cdrh/fedregin.html

. See section VI of this document for electronic access to the searchable database for the current list of FDA recognized consensus standards, including Recognition List Number: 014 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, 12720 Twinbrook Pkwy., Rockville, MD 20857, 301-827-0021.

SUPPLEMENTARY INFORMATION:

I. Background

Section 204 of the Food and Drug Administration Modernization Act of 1997 (FDAMA) (Public Law 105-115) amended section 514 of the Federal Food, Drug, and Cosmetic Act (the act) (21 U.S.C. 360d). Amended section 514 allows FDA to recognize consensus standards developed by international and national organizations for use in satisfying portions of device premarket review submissions or other requirements.

In a notice published in the

Federal Register

of February 25, 1998 (63 FR 9561), FDA announced the availability of a guidance entitled “Recognition and Use of Consensus Standards.” The notice described how FDA would implement its standard recognition program and provided the initial list of recognized standards.

In

Federal Register

notices published on October 16, 1998 (63 FR 55617), July 12, 1999 (64 FR 37546), November 15, 2000 (65 FR 69022), May 7, 2001 (66 FR 23032), January 14, 2002 (67 FR 1774), October 2, 2002 (67 FR 61893), April 28, 2003 (68 FR 22391), March 8, 2004 (69 FR 10712), June 18, 2004 (69 FR 34176), October 4, 2004 (69 FR 59240), May 27, 2005 (70 FR 30756), and November 8, 2005 (70 FR 67713), FDA modified its initial list of FDA recognized consensus standards. These notices describe the addition, withdrawal, and revision of certain standards recognized by FDA. The agency maintains “hypertext markup language” (HTML) and “portable document format” (PDF) versions of the list of “FDA Recognized Consensus Standards.” Both versions are publicly accessible at the agency's Web site. See section VI of this document for electronic access information. Interested persons should review the supplementary information sheet for the standard to understand fully the extent to which FDA recognizes the standard.

II. Modifications to the List of Recognized Standards, Recognition List Number: 014

FDA is announcing the addition, withdrawal, correction, and revision of certain consensus standards the agency will recognize for use in satisfying premarket reviews and other requirements for devices. FDA will incorporate these modifications in the list of FDA Recognized Consensus Standards in the agency's searchable database. FDA will use the term “Recognition List Number: 014” to identify these current modifications.

In table 1 of this document, FDA describes the following modifications: (1) The withdrawal of standards and their replacement by others, (2) the correction of errors made by FDA in listing previously recognized standards, and (3) the changes to the supplementary information sheets of recognized standards that describe revisions to the applicability of the standards.

In section III of this document, FDA lists modifications the agency is making that involve the initial addition of standards not previously recognized by FDA.

Table 1.

Old Item No.

Standard

Change

Replacement Item No.

A. Anesthesia

32

ISO 7767: 1997: Oxygen Monitors for Monitoring Patient Breathing Mixtures—Safety Requirements

Withdrawn

33

ISO 9918: 1993: Capnometers for Use with Humans—Requirements

Withdrawn

41

NFPA 99: 2005: Standard for Health Care Facilities Chapter 20—Hyperbaric Facilities

Withdrawn and replaced with newer version

67

B. Dental/Ear, Nose, and Throat

52

ANSI/ADA Specification No. 27: 1997, Resin-Based Filling Materials

Date

60

ANSI/ADA Specification No. 96: 2000, Dental-Water-Based Cements—Adoption of ISO 9917: 1991

Date and title

114

ANSI/ADA Specification No. 48: 2004, Ultraviolet Activator and Disclosing Lights

Date

C. General Hospital/General Plastic Surgery

47

ASTM D5712-05 Standard Test Method for Analysis of Aqueous Extractable Protein in Natural Rubber and Its Products Using the Modified Lowry Method

Withdrawn and replaced with newer version

144

77

ASTM F1862-00a Standard Test Method for Resistance of Medical Face Masks to Penetration by Synthetic Blood (Horizontal Projection of Fixed Volume at a Known Velocity)

Contact person

86

ASTM D3578-05 Standard Specification for Rubber Examination Gloves

Withdrawn and replaced with newer version

145

96

ASTM F2101-01 Standard Test Method for Evaluating the Bacterial Filtration Efficiency (BFE) of Medical Face Mask Materials, Using a Biological Aerosol of Staphylococcus Aureus

Contact person

112

AAMI/ANSI PB70: 2003 Liquid barrier performance and classification of protective apparel and drapes intended for use in health care facilities

Contact person

113

ASTM F2100-04 Standard Specification for Performance of Materials Used in Medical Face Masks

Contact person

120

ASTM F1054-01 Standard Specification for Conical Fittings

Withdrawn

128

ASTM F1670-03 Standard Test Method for Resistance of Materials Used in Protective Clothing to Penetration by Synthetic Blood

Contact person

D. Materials

14

ASTM F688-05: Standard Specification for Wrought Cobalt-35Nickel-20Chromium-10Molybdenum Alloy Plate, Sheet, and Foil for Surgical Implants (UNS R30035)

Withdrawn and replaced with newer version

119

38

ASTM F2005-00: Standard Terminology for Nickel-Titanium Shape Memory Alloys

Withdrawn

78

ASTM F560-05: Standard Specification for Unalloyed Tantalum for Surgical Implant Applications (UNS R05200, UNS R05400)

Withdrawn and replaced with newer version

120

100

ASTM F2005-05: Standard Terminology for Nickel-Titanium Shape Memory Alloys

Withdrawn and replaced with newer version

121

E. OB-GYN/Gastroenterology

19

ISO 8600-1: 2005 Optics and photonics—Medical endoscopes and endotherapy devices—Part 1: General requirements

Withdrawn and replaced with newer version

37

F. Orthopedic/Physical Medicine

162

ASTM F564-02: Standard Specification and Test Methods for Metallic Bone Staples

Extent of recognition, type of standard, contact person and related Code of Federal Regulations citation and product codes

164

ASTM F1541-02: Standard Specification and Test Methods for External Skeletal Fixation Devices

Devices affected, processes affected, extent of recognition, type of standard, and contact person

182

ASTM F1800-04: Standard Test Method for Cyclic Fatigue Testing of Metal Tibial Tray Components of Total Knee Joint Replacements

Processes affected and relevant guidance

G. Radiology

1

ISO 9236-1: 2004 Photography—Sensitometry of screen/film systems for medical radiography—Part 1: Determination of sensitometric curve shape, speed and Average Gradient

Withdrawn and replaced with newer version

136

2

ISO 4090: 2001 Photography—Medical radiographic cassettes/screens/films and hard-copy imaging films—Dimensions and specifications

Withdrawn and replaced with newer version

137

5

ISO 5799: 1991 Photography—Direct-exposing medical and dental radiographic film/process systems—Determination of ISO Speed and ISO average gradient

Withdrawn and replaced with newer version

138

37

IEC 60601-2-11-2004 Amendment 1—Medical electrical equipment—Part 2-11: Particular requirements for the safety of gamma beam therapy equipment

Withdrawn and replaced with newer version

133

44

AOMS-2005 Acoustic Output Measurement Standard for Diagnostic Ultrasound Equipment

Withdrawn and replaced with newer version

139

46

RTD1-2005 Standard for Real-Time Display of Thermal and Mechanical Acoustic Output Indices on Diagnostic Ultrasound Equipment Revision 1

Withdrawn and replaced with newer version

140

101

ANSI/IESNA RP-27.1-1996 Recommended Practice for Photobiological Safety for Lamps and Lamp Systems—General Requirements

Title

102

ANSI/IESNA RP-27.2-2000 Recommended Practice for Photobiological Safety for Lamps and Lamp Systems—Measurement Techniques

Title

103

ANSI/IESNA RP-27.3-1996 Recommended Practice for Photobiological Safety Lamps—Risk Group Classification and Labeling

Title

128

IEEE N42.13-2004 Calibration and Usage of “Dose Calibrator” Ionization Chambers for the Assay of Radionuclides

Withdrawn and replaced with newer version

141

H. Sterility

53

ANSI/AAMI ST66, Sterilization of health care products—Chemical indicators—Part 2: Indicators for Air Removal Test Sheets and Packs

Relevant guidance

74

ANSI/AAMI ST60, Sterilization of health care products—Chemical indicators—Part 1: General requirements

Extent of recognition and relevant guidance

92

ASTM F2097-05, Standard Guide for Design and Evaluation of Primary Packaging for Medical Products

Withdrawn and replaced with newer version

167

151

ASTM F2338-05, Standard Test Method for Nondestructive Detection of Leaks in Packages by Vacuum Decay Method

Withdrawn and replaced with newer version

168

III. Listing of New Entries

The listing of new entries and consensus standards added as modifications to the list of recognized standards under Recognition List Number: 014, follows:

Table 2.

Item No.

Title of Standard

Reference No. and Date

A. Cardiovascular/Neurology

58

Cardiovascular implants—Cardiac valve prostheses

ANSI/AAMI/ISO 5840: 2005

B. General Hospital/General Plastic Surgery

146

Medical electrical equipment—Part 2: Particular requirements for safety of infant radiant warmers

ANSI/AAMI/IEC 60601-2-21 and 60601-2-21 amendment 1: 2000

147

Standard Practice for Assessment of Resistance of Medical Gloves to Permeation by Chemotherapy Drugs

ASTM D6978-05

148

Sterile hypodermic syringes for single use—Part 3: Auto-disable syringes for fixed-dose immunization

ISO 7886-3: 2005

149

Standard Practice for Determination of Expiration Dating for Medical Gloves

ASTM D7160-05

150

Standard Practice for Determination of Real Time Expiration Dating of Mature Medical Gloves Stored Under Typical Warehouse Conditions

ASTM D7161-05

C. Orthopedic/Physical Medicine

183

Standard Practice for Fretting Corrosion Testing of Modular Implant Interfaces: Hip Femoral Head-bore and Cone Taper Interface

ASTM F1875-98 (2004)

184

Implants for Surgery—Staples with parallel legs for orthopaedic use—General requirements

ISO 8827: 1988

185

Standard Test Method for Measuring Load Induced Subsidence of an Intervertebral Body Fusion Device Under Static Axial Compression

ASTM F2267-04

186

Test Methods for Intervertebral Body Fusion Devices

ASTM F2077-03

187

Standard Specifications and Test Methods for Components Used in the Surgical Fixation of the Spinal Skeletal System

ASTM F2193-02

188

Implants for surgery—Wear of total knee-joint prostheses—Part 1: Loading and displacement parameters for wear-testing machines with load control and corresponding environmental conditions for test

ISO 14243-1: 2002

189

Implants for surgery—wear of total knee-joint prostheses—Part 2: Methods of measurement

ISO 14243-2: 2000

190

Implants for surgery—wear of total knee-joint prostheses—Part 3: Loading and displacement parameters for wear-testing machines with displacement control and corresponding environmental conditions for test

ISO 14243-3: 2004

191

Implants for surgery—Total knee-joint prostheses—Part 1: Determination of endurance properties of knee tibial trays

ISO 14879-1: 2000

192

Standard Test Method for Determination of Total Knee Replacement Constraint

ASTM F1223-05

193

Standard Specification for Total Knee Prosthesis

ASTM F2083-04

D. Radiology

142

Lasers and laser-related equipment—Test methods for laser beam widths, Divergence angles, and beam propagation ratios—Part 2: General astigmatic beams

ISO 11146-2: 2005

143

Lasers and laser-related equipment—Test methods for determination of the shape of a laser beam wavefront—Part 2: Shack-Hartmann sensors

ISO 15367-2: 2005

E. Sterility

169

Standard Test Method for Measuring Package and Seal Integrity Using Helium as Tracer Gas

ASTM F2391-05

170

Standard Guide for Biocompatibility Evaluation of Medical Device Packaging Materials

ASTM F2475-05

171

Chemical Indicators—Guidance on the selection, use, and interpretation of results

ANSI/AAMI/ISO 15882: 2003

IV. List of Recognized Standards

FDA maintains the agency's current list of FDA recognized consensus standards in a searchable database that may be accessed directly at FDA's Web site at

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfstandards/search.cfm

. FDA will incorporate the modifications and minor revisions described in this notice into the database and, upon publication in the

Federal Register

, this recognition of consensus standards will be effective. FDA will announce additional modifications and minor revisions to the list of recognized consensus standards, as needed, in the

Federal Register

once a year, or more often, if necessary.

V. Recommendation of Standards for Recognition by FDA

Any person may recommend consensus standards as candidates for recognition under the new provision of section 514 of the act by submitting such recommendations, with reasons for the recommendation, to the contact person (see

FOR FURTHER INFORMATION CONTACT

). To be properly considered such recommendations should contain, at a minimum, the following information: (1) Title of the standard, (2) any reference number and date, (3) name and address of the national or international standards development organization, (4) a proposed list of devices for which a declaration of conformity to this standard should routinely apply, and (5) a brief identification of the testing or performance or other characteristics of the device(s) that would be addressed by a declaration of conformity.

VI. Electronic Access

In order to receive “Guidance on the Recognition and Use of Consensus Standards” on your fax machine, call the Center for Devices and Radiological Health (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 also 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 the 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: 014” 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 database for “FDA Recognized Consensus Standards” through the hyperlink at

http://www.fda.gov/cdrh/stdsprog.html

.

This

Federal Register

document on modifications in FDA's recognition of consensus standards is available at

http://www.fda.gov/cdrh/fedregin.html

.

VII. Submission of Comments and Effective Date

Interested persons may submit to the contact person (see

FOR FURTHER INFORMATION CONTACT

) written or electronic comments regarding this document. Submit a single copy of electronic comments or two paper copies of any mailed comments, except that individuals may submit one paper copy. Comments are to be identified 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: 014. These modifications to the list of recognized standards are effective upon publication of this notice in the

Federal Register

.

Dated: March 23, 2006

Linda S. Kahan,

Deputy Director, Center for Devices and Radiological Health.

[FR Doc. E6-4695 Filed 3-30-06; 8:45 am]

BILLING CODE 4160-01-S