[Federal Register Volume 62, Number 188 (Monday, September 29, 1997)]
[Notices]
[Pages 50953-50954]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 97-25669]


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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General Principles of Software Validation; Draft Guidance; 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availability of a draft guidance entitled ``General Principles of 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 The draft guidance discusses how the general provisions of the 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additional time for comment on this draft guidance document.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FR 40099), FDA announced the availability of a draft guidance entitled 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 The draft guidance 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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