Minimizing the adverse effects of the medical device amendments of 1976 on innovation in artificial organs research. (Including a proposed short-form application to the FDA for investigational exemptions).
D000818:Animals; D001187:Artificial Organs / Q000592:standards*; D002417:Cattle; D004864:Equipment and Supplies / Q000592:standards*; D049673:History, 20th Century; D006801:Humans; D007880:Legislation, Drug / Q000266:history; D012107:Research Design; D014481:United States; D014486:United States Food and Drug Administration