[Federal Register Volume 66, Number 88 (Monday, May 7, 2001)]
[Notices]
[Pages 23032-23034]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 01-11329]


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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: 005

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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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: 005'' (Recognition List Number: 005) will assist manufacturers 
who elect to declare conformity with consensus standards to meet 
certain requirements for medical devices.

DATES: Submit written comments concerning this document at any time. 
See section VI 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: 005,'' 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 to the contact person (address 
below). Comments should be identified with the docket number found in 
brackets in the heading of this document. This document may also be 
accessed 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: 005 
modifications, and other standards related information.

FOR FURTHER INFORMATION CONTACT: To comment on this document and/or to 
recommend additional standards for recognition: 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 the 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), and November 15, 2000 (65 FR 
69022), FDA modified its initial list of recognized standards. These 
notices described the addition, withdrawal, and revision of certain 
standards recognized by FDA. When these notices were published, the 
agency maintained ``html'' and ``pdf'' versions of the list of ``FDA 
Recognized Consensus Standards.'' Both versions were publicly 
accessible at the agency's Internet site. The agency maintains the 
current list in a searchable database accessible to the public. See 
section V of this document for electronic access information.

II. Discussion of Modifications to the List of Recognized 
Standards, Recognition List Number: 005

    FDA is announcing the addition, withdrawal, correction, and 
revision of certain consensus standards the agency will recognize for 
use in satisfying premarket reviews 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: 005'' to identify: (1) Supplementary 
information sheets for standards added to the list for the first time, 
(2) standards added to replace withdrawn standards, and (3) still 
recognized standards for which minor revisions are made to clarify the 
application of the standards.
    At the end of this notice, FDA lists modifications the agency is 
making that involve: (1) The initial addition of standards not 
previously recognized by FDA and (2) the addition of standards in 
conjunction with the withdrawal of other standards that are replaced by 
these later, amended, or different standards.
    In this section, FDA describes modifications that involve the 
withdrawal of standards and their replacement by others. In this 
notice, all changes of this type are in the sterility category of the 
complete list of recognized standards.
    1. ASTM-F1140:1996 is withdrawn under previous item 59. ASTM-
F1140:2000 is added under current item 67.
    2. ASTM-F1585:1995 is withdrawn under previous item 61. ASTM 
F1585:2000 is added under current item 68.
    3. ASTM-1608:1995 is withdrawn under previous item 62. ASTM 
F1608:2000 is added under current item 69.

III. 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 Intranet site at http://

[[Page 23033]]

www.acessdata.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.

IV. 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 (address above). To be properly considered, such 
recommendations should contain, at a minimum, the following 
information: (1) Title of standards, (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.
    Persons interested in obtaining a copy of ``Guidance on the 
Recognition and Use of Consensus Standards'' may also do so by using 
the Internet. CDRH maintains a site on the Internet for easy access to 
information including text, graphics, and files that may be downloaded 
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: 005'' will be available on the CDRH home page. 
The CDRH home page may be accessed at http://www.fda.gov/cdrh. The 
``Guidance on the Recognition and Use of Consensus Standards,'' and the 
searchable database for ``FDA Recognized Consensus Standards,'' may be 
accessed through hyper links 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 and Effective Date

    Interested persons may, at any time, submit to the contact person 
(address above) written comments regarding this document. Two copies of 
any comments are to be submitted, except that individuals may submit 
one copy. Comments are to be identified with the docket number found in 
brackets in the heading of this document. Received comments will be 
considered in determining whether to amend the current listing of 
``Modifications to the List of Recognized Standards, Recognition List 
Number: 005.''
    The recognition of standards announced in this notice of 
modifications will become effective on May 7, 2001.

VII. 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: 005, is as follows:

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    Item Number                         Title of Standards                          Reference Number and Date
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                                                   Anesthesia
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34                  Standard Test Method for Evaluation the Ignition            ASTM PS127:2000
                     Sensitivity and Fault Tolerance of Oxygen Regulators Used
                     for Medical and Emergency Applications
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                                            Cardiovascular/Neurology
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31                  Standard Practice for Evaluating and Specifying             ASTM F647-94
                     Implantable Shunt Assemblies for Neurosurgical
                     Applications
32                  Standard Specification for the Requirements and Disclosure  ASTM F1542-94 (2000)
                     of Self-Closing Aneurysm Clips
33                  Neurosurgical Implants-Sterile, Single-Use Hydrocephalus    ISO 7197:1997
                     Shunts and Components
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                                                     General
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25                  Standard for the Development of an Electrostatic Discharge  ANSI/ESD S20.20-1999
                     Control Program
26                  Medical Devices-Application of Risk Management to Medical   ISO 14971:2000
                     Devices
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Sterility
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67                  Standard Test Methods for Internal Pressurization Failure   ASTM F1140:2000
                     Resistance of Unrestrained Packages for Medical
                     Applications
68                  Standard Guide for Integrity Testing of Porous Barrier      ASTM F1585:2000
                     Medical Packages
69                  Standard Test Method for Microbial Ranking of Porous        ASTM F1608:2000
                     Packaging Materials (Exposure Chamber Method)
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[[Page 23034]]

    Dated: April 24, 2001.
David W. Feigal, Jr.,
Director, Center for Devices and Radiological Health.
[FR Doc. 01-11329 Filed 5-4-01; 8:45 am]
BILLING CODE 4160-01-S