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Showing 1 to 1 of 1 for “"Medical Device Amendments"”.
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The Impact of Federal Regulation on Time to Equivalence and Compliance within the Orthopaedic Medical Device Industry
The Medical Device Amendments of 1976 (Public Law 94-295) consolidated and expanded existing federal authority over manufacturers of medical devices. This meant that any medical device manufactured after the Medical Device Amendment of 1976 needed to establish that it is substantially equivalent in …