Medical Devices: Status of FDA's Program for Inspections by Accredited Organizations
Description:
A letter report issued by the Government Accountability Office with an abstract that begins "The Food and Drug Administration (FDA) inspects domestic and foreign establishments where U.S.-marketed medical devices are manufactured to assess compliance with FDA's quality system requirements for ensuring good manufacturing practices and other applicable requirements. The Medical Device User Fee and Modernization Act of 2002 (MDUFMA) required FDA to accredit organizations to inspect certain establi…
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Date:
January 5, 2007
Creator:
United States. Government Accountability Office.
Item Type:
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Report
Partner:
UNT Libraries Government Documents Department