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GAO Report on FDA's Program for Inspections of Medical Devices by Accredited Organizations

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Medical Devices: Status of FDA’s Program for Inspections by Accredited Organizations, Full text GAO-07-157, and Highlights, January 5, 2007.

  • “GAO examined FDA documents, interviewed FDA officials, and obtained information from FDA on the number of inspections conducted from March 11, 2004–when FDA first cleared an accredited organization to conduct independent inspections–through October 31, 2006. GAO also interviewed affected entities, including accredited organizations and medical device manufacturers.”
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