General Principles of Software Validation; Draft Guidance; Extension of the Comment Period

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 97D-0282]

General Principles of Software Validation; Draft Guidance;

Extension of the Comment Period

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice; extension of comment period.

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SUMMARY: The Food and Drug Administration (FDA) is extending to

December 30, 1997, the comment period for the notice announcing the

availability of a draft guidance entitled ``General Principles of

Software Validation'' that published in the Federal Register of July

25, 1997 (62 FR

[[Page 50954]]

40099). The draft guidance discusses how the general provisions of the

Quality System Regulation apply to software and the agency's current

approach to evaluating a software validation system. The agency is

taking this action in response to a request for an extension to allow

additional time for comment on this draft guidance document.

DATES: Written comments by December 30, 1997.

ADDRESSES: Submit written comments to the Dockets Management Branch

(HFA-305), Food and Drug Administration, 12420 Parklawn Dr., rm. 1-23,

Rockville, MD 20857. Comments should be identified with the docket

number found in brackets in the heading of this document.

FOR FURTHER INFORMATION CONTACT: E. Stewart Crumpler, Center for

Devices and Radiological Health (HFZ-343), Food and Drug

Administration, 2094 Gaither Rd., Rockville, MD 20850, 301-594-4659.

SUPPLEMENTARY INFORMATION: In the Federal Register of July 25, 1997 (62

FR 40099), FDA announced the availability of a draft guidance entitled

``General Principles of Software Validation.'' The draft guidance

discusses how the general provisions of the Quality System Regulation

apply to software and the agency 's current approach to evaluating a

software validation system. Interested persons were given until October

1, 1997, to submit written comments on the notice. FDA received a

request from the Health Industry Manufacturers Association to extend

the comment period for 90 days. This would give them sufficient time to

review the document and ensure quality comments on the document.

FDA is extending the comment period for 90 days to assure adequate

time for preparation of comments. Accordingly, FDA finds under section

520(d) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C 360j(d))

that there is good cause for such an extension.

Interested persons may, on or before December 30, 1997, submit to

the Docket Management Branch (address above) written comments regarding

the notice. 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 may be seen in the office above between 9 a.m. and 4

p.m., Monday through Friday.

Dated: August 28, 1997.

Joseph A. Levitt,

Deputy Director for Regulations Policy, Center for Devices and

Radiological Health.

[FR Doc. 97-25669 Filed 9-26-97; 8:45 am]

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