[Federal Register Volume 63, Number 121 (Wednesday, June 24, 1998)]
[Notices]
[Pages 34433-34442]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 98-16736]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration
[Docket No. 98D-0376]


Guidance on FDA's Expectations of Medical Device Manufacturers 
Concerning the Year 2000 Date Problem

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is announcing the 
availability of the guidance entitled ``Guidance on FDA's Expectations 
of Medical Device Manufacturers Concerning the Year 2000 Date 
Problem.'' The guidance, which is included in this notice, is a Level 1 
guidance that is immediately effective in accordance with FDA's good 
guidance practices (GGP's) criteria, which allow immediate 
implementation of guidance that is necessary for public health reasons. 
FDA will receive comments on the guidance at any time and consider them 
in determining whether to amend the current guidance.
DATES: This guidance is effective June 24, 1998. Submit written 
comments by September 22, 1998. After the close of the comment period, 
written comments may be submitted at any time to Thomas B. Shope 
(address below).

ADDRESSES: See the SUPPLEMENTARY INFORMATION section for information on 
electronic access to the guidance in this notice.
    Submit comments during the comment period to: Dockets Management 
Branch (HFA-305), Food and Drug Administration, 12420 Parklawn Dr., rm. 
1-23, Rockville, MD 20857. Such comments will be considered when 
determining whether to amend the current guidance. Comments should be 
identified with the docket number found in brackets in the heading of 
this document.
    Submit comments at any time after the close of the comment period 
to: Thomas B. Shope (address below). Comments may not be acted upon by 
the agency until the document is next revised or updated.
FOR FURTHER INFORMATION CONTACT: Thomas B. Shope, Center for Devices 
and Radiological Health (HFZ-140), Food and Drug Administration, 9200 
Corporate Blvd., Rockville, MD 20850, 301-443-3314, ext. 32.
SUPPLEMENTARY INFORMATION:

I. Background

    The guidance entitled ``Guidance on FDA's Expectations of Medical 
Device Manufacturers Concerning the Year 2000 Date Problem'' reviews 
the legal responsibilities of device manufacturers under the Federal 
Food, Drug, and Cosmetic Act in ensuring the uninterrupted functioning 
of any medical device that might be impacted by the Year 2000 date 
problem. It also reviews legislative and regulatory requirements 
applicable to device manufacturers with regard to correcting potential 
Year 2000 problems, to indicate when corrective action is or is not 
required, to present recommendations for device assessment, and to 
encourage reporting on the status of devices that are adversely 
affected by the Year 2000 date problem.

II. Significance of Guidance

    This guidance document represents the agency's current thinking on 
FDA's

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expectations of medical device manufacturers concerning the Year 2000 
date problem. It does not create or confer any rights for or on any 
person and does not operate to bind FDA or the public. An alternative 
approach may be used if such approach satisfies the applicable statute, 
regulations, or both.
    The agency has adopted GGP's that set forth the agency's policies 
and procedures for the development, issuance, and use of guidance 
documents (62 FR 8961, February 27, 1997). This guidance document is 
issued as a Level 1 guidance consistent with GGP's.

III. Electronic Access

    In order to receive the guidance entitled ``Guidance on FDA's 
Expectations of Medical Device Manufacturers Concerning the Year 2000 
Date Problem'' via your fax machine, call the CDRH Facts-On-Demand 
(FOD) system at 800-899-0381 or 301-827-0111 from a touch-tone 
telephone. At the first voice prompt press 1 to access DSMA Facts, at 
the second voice prompt press 2, and then enter the document number 
2000 followed by the pound sign (#). Then follow the remaining voice 
prompts to complete your request.
    Persons interested in obtaining a copy of the guidance may also use 
the World Wide Web (WWW). CDRH maintains an entry on the WWW for easy 
access to information including text, graphics, and files that may be 
downloaded to a personal computer with access to the Web. Updated on a 
regular basis, the CDRH home page includes guidances, device safety 
alerts, Federal Register reprints, information on premarket submissions 
(including lists of approved applications and manufacturers' 
addresses), small manufacturers' assistance, information on video 
conferencing and electronic submissions, mammography matters, and other 
device-oriented information. The CDRH home page may be accessed at 
http://www.fda.gov/cdrh. The guidance entitled ``Guidance on FDA's 
Expectations of Medical Device Manufacturers Concerning the Year 2000 
Date Problem'' will be available at <a href="http://www.fda.gov/cdrh/yr2000/
y2kguide.html">http://www.fda.gov/cdrh/yr2000/
y2kguide.html</a>.
    A text-only version of the CDRH web site is also available from a 
computer or VT-100 compatible terminal by dialing 800-222-0185 
(terminal settings are 8/1/N). Once the modem answers, press Enter 
several times and then select menu choice 1: FDA BULLETIN BOARD 
SERVICE. From there follow instructions for logging in, and at the BBS 
TOPICS PAGE, arrow down to the FDA home page (do not select the first 
CDRH entry). Then select Medical Devices and Radiological Health. From 
there select CENTER FOR DEVICES AND RADIOLOGICAL HEALTH for general 
information, or arrow down for specific topics.

IV. Comments

    Interested persons may, on or before September 22, 1998, submit to 
the Dockets Management Branch (address above) written comments 
regarding the guidance for medical devices. After the close of the 
comment period, comments may be submitted at any time to Thomas B. 
Shope (address above). 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. A copy of the guidance and received comments may be seen 
in the Dockets Management Branch between 9 a.m. and 4 p.m., Monday 
through Friday.

    Dated: June 11, 1998.
Linda S. Kahan,
Acting Deputy Director for Regulations Policy, Center for Devices and 
Radiological Health.
     The text of the guidance is set forth below:

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[FR Doc. 98-16736 Filed 6-23-98; 8:45 am]
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