Y2K compliance reporting
This article was originally published in The Gray Sheet
Executive Summary
About 150 device manufacturers "have not yet provided data" to FDA indicating whether their products are Year 2000 compliant, the agency says in a Federal Register notice scheduled for publication Aug. 16. About 300 other firms have supplied information "that is either incomplete or that requires clarification," FDA says in the notice, which requests emergency approval from the Office of Management and Budget to continue to solicit such information through Feb. 29, 2000. FDA estimates each of the roughly 450 firms will need about eight hours to complete a response
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