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

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 http://www.fda.gov/cdrh/yr2000/

y2kguide.html.

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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