[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