書誌事項

Overview of the Medical device amendment

Center for Devices and Radiological Health, U.S. Food and Drug Administration

The Center, 1988 , Distributed by National Audiovisual Center

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注記

Cataloged from contributor's data

Manufacturers of medical devices

Issued as U-matic 3/4 in. or Beta 1/2 in. or VHS 1/2 in

Summary: Presents an overview of the 1976 Medical device amendments to the Food, Drug and Cosmetic Act. Describes how the amendments evolved, the regulatory scope of the amendments, how devices are classified, good manufacturing practices, and where to get help with questions about compliance with the amendments

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