Food and Drug Administration Modernization Act of 1997: Modifications to the List of Recognized Standards, Recognition List Number: 010

Federal RegisterJun 18, 2004

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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: 010

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 of the List of Recognized Standards, Recognition List Number: 010” (Recognition List Number: 010), will assist manufacturers who elect to declare conformity with consensus standards to meet certain requirements for medical devices.

DATES:

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

ADDRESSES:

Submit written requests for single copies on a 3.5″ diskette of “Modification to the List of Recognized Standards, Recognition List Number: 010” to the Division of Small Manufacturers 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 to recommend additional standards for recognition to the contact person (see

FOR FURTHER INFORMATION CONTACT

). Submit electronic comments by e-mail:

standards@cdrh.fda.gov

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

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

. See section VI of this document for electronic access to the searchable database for the current list of “FDA Recognized Consensus Standards,” including Recognition List Number: 010 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 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 document entitled “Recognition and Use of Consensus Standards.” This notice described how FDA will implement its standard recognition program and provided the initial list of recognized standards.

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), and March 8, 2004 (69 FR 10712), FDA modified its initial list of recognized standards. These notices described the addition, withdrawal, and revision of certain standards recognized by FDA. The agency maintains 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 Internet 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: 010

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: 010” to identify these current modifications.

In the following table, FDA describes modifications that involve: (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.

A. Anesthesia

Old Item No.

Standard

Change

Replacement Item No.

ISO 8382:1988, Resuscitators Intended for Use with Humans

Processes impacted, extent of recognition, relevant guidance

ISO 5360:1993, Anaesthetic vaporizers—Agent-specific filling systems

Devices affected, processes impacted, extent of recognition

B. General

Old Item No.

Standard

Change

Replacement Item No.

IEC 60601-1, Medical Electrical Equipment—Part 1: General Requirements for Safety

Contact person

IEC 60601-1-2 (Second Edition, 2001) Medical Electrical Equipment—Part 1: General Requirements for Safety; Electromagnetic Compatibility—Requirements and Tests

Contact person

ANSI/AAMI/IEC 60601-1-2:2001, Medical Electrical Equipment—Parts 1 to 2: General Requirements for Safety—Collateral Standard: Electromagnetic Compatibility—Requirements and Tests

Correct title of standard

C. General Hospital/General Plastic Surgery

Old Item No.

Standard

Change

Replacement Item No.

ASTM F754-88, Standard Specification for Implantable Polytetrafluoroethylene (PTFE) Polymer Fabricated in Sheet, Tube and Rod Shapes

Withdrawn and replaced with new version

108

ASTM F881-94, Standard Specification for Elastomer Facial Implants

Withdrawn and replaced with newer version

109

ASTM F1441-92, Standard Specification for Soft Tissue Expanders

Withdrawn and replaced with newer version

110

IEC 60601-2-38, Medical Electrical Equipment—Part 2: Particular Requirements for the Safety of Electrically Operated Hospital Beds

Withdrawn and replaced with newer version

111

D. In Vitro Diagnostic

Old Item No.

Standard

Change

Replacement Item No.

NCCLS MM2-A2 Immunoglobulin and T-Cell Receptor Gene Rearrangement Assays; Approved Guideline—Second Edition

Withdrawn and replaced with newer version

CEN 13640, Stability Testing of In Vitro Diagnostic Reagents

Correction to date of standard

E. Materials

Old Item No.

Title of Standard

Change

Replacement Item No.

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)

Title change

ASTM F2052-02, Standard Test Method for Measurement of Magnetically Induced Displacement Force on medical Devices in the Magnetic Resonance Environment

Recognizing a newer version with a revised title

ASTM F2182-02a, Standard Test Method for Measurement of Radio Frequency Induced Heating Near Passive Implants During Magnetic Resonance Imaging

Recognizing a newer version

ISO 5832-1:1997, Implants for Surgery—Metallic materials—Part 1: Wrought stainless steel

Transferred from Orthopedics 62 to Materials 56

ISO 5832-3:1996, Implants for Surgery—Metallic materials—Part 3: Wrought titanium 6-aluminum 4-vanadium alloy

Transferred from Orthopedics 64 to Materials 58

ISO 5832-4:1996, Implants for Surgery—Metallic materials—Part 4: Cobalt-chromium-molybdenum casting alloy

Transferred from Orthopedics 65 to Materials 59

ISO 5832-1:1997, Implants for Surgery—Metallic materials—Part 1: Wrought stainless steel

Transferred from Orthopedics 62 to Materials 56

ISO 5832-3:1996, Implants for Surgery—Metallic materials—Part 3: Wrought titanium 6-aluminum 4-vanadium alloy

Transferred from Orthopedics 64 to Materials 58

ISO 5832-4:1996, Implants for Surgery—Metallic materials—Part 4: Cobalt-chromium-molybdenum casting alloy

Transferred from Orthopedics 65 to Materials 59

ISO 5832-5:1993, Implants for Surgery—Metallic materials—Part 5: Wrought cobalt-chromium-tungsten-nickel alloy

Transferred from Orthopedics 66 to Materials 60

ISO 5832-6:1997, Implants for Surgery—Metallic materials—Part 6: Wrought cobalt-nickel-chromium-molybdenum alloy

Transferred from Orthopedics 67 to Materials 61

ISO 5832-11:1994, Implants for Surgery—Metallic materials—Part 11: Wrought titanium 6-aluminum 7-niobium alloy

Transferred from Orthopedics 70 to Materials 63

ISO 5832-12:1996, Implants for Surgery—Metallic materials—Part 12: Wrought cobalt-chromium-molybdenum alloy

Transferred from Orthopedics 71 to Materials 64

ISO 6474-94, Implants for surgery—Ceramic materials based on high purity alumina

Transferred from Orthopedics 76 to Materials 66

ISO 13782:1996, Implants for surgery—Metallic materials—Unalloyed tantalum for surgical implant applications

Transferred from Orthopedics 84 to Materials 68

117

ISO 5832-2:1999, Implants for Surgery—Metallic Materials—Part 2: Unalloyed Titanium

Transferred from Orthopedics 117 to Materials 57

118

ISO 5832-9:1992, Implants for Surgery—Metallic Materials—Part 9: Wrought High Nitrogen Stainless Steel

Transferred from Orthopedics 118 to Materials 62

119

ISO 5834-2:1998, Implants for Surgery—Ultra-High-Molecular Weight Polyethylene—Part 2: Moulded Forms

Transferred from Orthopedics 119 to Materials 65

143

ISO 7153-1:1991/Amd. 1:1999, Surgical instruments—Metallic materials—Part 1: Stainless steel

Transferred from Orthopedics 143 to Materials 67

F. Radiology

Old Item No.

Standard

Change

Replacement Item No.

ANSI Ph 2.50-1983, Photography—Direct-Exposing Medical and Dental Radiographic Film/Process Systems—Determination of ISO Speed and Average Gradient

Title correction

ISO/IEC 10918-1:1994, Information Technology—Digital Compression and Coding of Continuous—Tone Still Images: Requirements and Guidelines

Title correction

IEC 60336 (R1993), X-ray Tube Assemblies for Medical Diagnosis Characteristics of Focal Spots

Title correction

NEMA MS 8-1993 (2000), Characterization of the Specific Absorption Rate for Magnetic Resonance Imaging Systems

Reaffirmation

NEMA XR 5-1992 (R1999), Measurement of Dimensions and Properties of Focal Spots of Diagnostic X-ray Tubes

Reaffirmation

NEMA XR 10-1986 (R1992, R1998), Measurement of the Maximum Symmetrical Radiation Field from a Rotating Node X-ray Tube used for Medical Diagnosis

Reaffirmation

NEMA XR 11-1993 (R1999), Test Standard for Determination of the Limiting Spatial Resolution of X-ray Image Intensifier Systems

Title correction

NEMA XR 15-1991 (R1996, R2001), Test Standard for the Determination of the Visible Entrance Field Size of an X-ray Image Intensifier System

Reaffirmation

NEMA XR 16-1991 (R1996, R2001), Test Standard for the Determination of the System Contrast Ratio and the System Veiling Glare Index of an X-ray Image Intensifier System

Reaffirmation

NEMA XR 17-1993 (R1999), Test Standard for the Measurement of the Image Signal Uniformity of an X-ray Image Intensifier System

Reaffirmation

NEMA XR 18-1993 (R1999), Test Standard for the Determination of the Radial Image Distortion of an X-ray Image Intensifier System

Reaffirmation

NEMA XR 19-1993 (R1999), Thermal and Loading Characteristics of X-ray Tubes used for Medical Diagnosis

Reaffirmation

AIUM AOMS—Acoustic Output Measurement Standard for Diagnostic Ultrasound Equipment

Title correction and reaffirmation

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

Title correction and reaffirmation

AIUM AOL—Acoustic Output Labeling Standard for Diagnostic Ultrasound Equipment: A Standard for How Manufacturers Should Specify Acoustic Output Data

Title correction

UL 122-1999, Standard for Safety of Photographic Equipment—4th Edition

Title correction

AIUM MUS—Medical Ultrasound Safety

Title correction and reaffirmation

NEMA UD 3-1998, Revision 1, Standard for Real Time Display of Thermal and Mechanical Acoustic Output Indices on Diagnostic Ultrasound Equipment

Title correction

NEMA MS 2-2003, Determination of Two-Dimensional Geometric Distortion in Diagnostic Magnetic Resonance Images

Withdrawn and replaced with newer version

NEMA MS 3-2003, Determination of Image Uniformity in Diagnostic Magnetic Resonance Images

Withdrawn and replaced with newer version

NEMA MS-1-2001, Determination of Signal to Noise Ratio (SNR) in Diagnostic Magnetic Resonance Images

Withdrawn and replaced with newer version

NEMA MS 6-1991 (R2000), Characterization of Special Purpose Coils for Diagnostic Magnetic Resonance Images

Reaffirmation

ANSI IT1.49-1995, Photography (Films)—Medical Radiographic Cassettes/Screens/Films-Dimensions

Withdrawn and replaced with Item 98

NEMA MS 5-2003, Determination of Slice Thickness in Diagnostic Magnetic Resonance Imaging

Withdrawn and replaced with newer version

G. Sterility

Old Item No.

Standard

Change

Replacement Item No.

AAMI/ANSI/ISO 10993-7:1995 (R) 2001, Biological Evaluation of Medical Devices—Part 7: Ethylene Oxide Sterilization Residuals

Deleted “Hemodialyzers” from Extent of Recognition

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: 010, is as follows:

A. Anesthesia

Item No.

Title of Standard

Reference No. and Date

Ancillary devices for expired air resuscitation

AS 4259-1995

Standard Specification for Electrically Powered Home Care Ventilators, Part 1—Positive-Pressure Ventilators and Ventilator Circuits

ASTM F1246-91(1999)

Standard Specification for Suction Catheters for Use in the Respiratory Tract

ASTM F1981-99

B. General

Item No.

Title of Standard

Reference No. and Date

Medical Electrical Equipment—Parts 1 to 8: General requirements for safety—Collateral Standard: Alarm systems—Requirements, tests, and guidelines—General requirements and guidelines for alarm systems in medical equipment

IEC 60601-1-8:2003

C. In Vitro Diagnostic

Item No.

Title of Standard

Reference No. and Date

Nucleic Acid Amplification Assays for Molecular Hematopathology; Approved Guideline

NCCLS MM5-A:2000

100

In Vitro Diagnostic Test Systems—Requirements for In Vitro Whole Blood Glucose Monitoring Systems Intended for Use by Patients for Self Testing in Management of Diabetes Mellitus, First Edition

ISO 15197:2003

101

Assays of vonWillebrand Factor Antigen and Ristocetin Cofactor Activity; Approved Guideline

NCCLS H51-A:2002

D. Materials

Item No.

Title of Standard

Reference No. and Date

Standard Test Method for Measurement of Magnetically Induced Torque on Medical Devices in the Magnetic Resonance Environment

ASTM F2213-04

E. Radiology

Item No.

Title of Standard

Reference No. and Date

Medical Electrical Equipment—Dosimeters with Ionization Chambers as Used in Radiotherapy

IEC 60731—Amendment 1 2002-06

IV. List of Recognized Standards

FDA maintains the agency's current list of FDA Recognized Consensus Standards in a searchable database that may be accessed directly at FDA's Internet site at

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

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

Federal Register

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

Federal Register

once a year, or more often, if necessary.

V. Recommendation of Standards for Recognition by FDA

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

FOR FURTHER INFORMATION CONTACT

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

VI. Electronic Access

In order to receive “Guidance on the Recognition and Use of Consensus Standards” via your fax machine, call the CDRH Facts-On-Demand system at 800-899-0381 or 301-827-0111 from a touch-tone telephone. Press 1 to enter the system. At the second voice prompt press 1 to order a document. Enter the document number 321 followed by the pound sign (#). Follow the remaining voice prompts to complete your request.

You may obtain a copy of “Guidance on the Recognition and Use of Consensus Standards” by using the Internet. CDRH maintains a site on the Internet for easy access to information including text, graphics, and files that you may download to a personal computer with access to the Internet. Updated on a regular basis, the CDRH home page includes 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 “Modification to the List of Recognized Standards, Recognition List Number: 010” 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 hyperlink at

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

. This

Federal Register

notice of modifications in FDA's recognition of consensus standards will be available, upon publication, at

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

VII. Submission of Comments and Effective Date

Interested persons may submit to the contact person (see

FOR FURTHER INFORMATION CONTACT

) written or electronic comments regarding this document. Two copies of any mailed comments are to be submitted, except that individuals may submit one 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: 010.” These modifications to the list or recognized standards are effective upon publication of this notice in the

Federal Register

Dated: June 2, 2004.

Linda S. Kahan,

Deputy Director, Center for Devices and Radiological Health.

[FR Doc. 04-13725 Filed 6-17-04; 8:45 am]

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