Zdrowie i gospodarka · 29/09/1997

General Principles of Software Validation; Draft Guidance; Extension of the Comment Period

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(FDA) is extending to December 30, 1997, the comment period for the notice announcing the availability of a draft guidance entitled ``General Principles of Software Validation'' that published in the Federal Register of July 25, 1997 (62 FR 40099). The draft guidance discusses how the general provisions of the Quality System Regulation apply to software and the agency's current approach to evaluating a software validation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The agency is taking this action in response to a request for an extension to allow additional time for comment on this draft guidance document.