Unlike the history of drug regulation within the United States, there seems to be no single, major incident to which one can attribute the genesis of medical device regulation. While there is a history of product failures and recall of devices having potentially serious consequences (Beck, 1979b), the impetus behind government regulation of medical devices seems to have been the increasing complexity of medical technology, the number of new therapeutic and diagnostic devices entering the market, and the general regulatory atmosphere prevalent in the United States. The intent has been to prevent a “thalidomide” in the world of medical devices.
KeywordsMedical Device Clinical Investigator Versus Versus Versus Versus Versus Knee Brace Tongue Depressor
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