The 1976 Medical Device Amendments
After 1938 Medical Devices were brought under control of the FDA . While pre-market approval did not apply to Medical Devices, the 1938 law equated them to drugs for regulatory purposes. A therapeutic disaster in which thousands of women were injured by the Dalkon Shield intrauterine device led to the passing of the 1976 Medical Device Amendments. The amendments require manufacturers to register with FDA and follow quality control procedures. Some products must have pre-market approval by FDA ; others must meet performance standards before marketing