Legislation to Regulate Medical Devices

Abstract

In Congressional hearings on legislation to give the Food and Drug Administration authority to regulate medical devices, a physician testified: “Under current standards of nonregulation in the United States, I could take a paper clip and fashion it into an IUD (intra-uterine device). I could then begin inserting it into women without even informing them that it is an experimental and never-tested IUD. And I would not even have to inform the FDA of my newly invented IUD.” Physicians, scientists, consumers, manufacturers, Congress and the Nixon Administration were all in agreement that FDA needs additional authority, through new legislation, to oversee the safety and efficacy of medical devices. An HEW commission recommended that medical devices be classified by FDA into three categories: those requiring testing prior to marketing, those for which standards would be sufficient to protect the public health and safety, and those generally recognized as safe and requiring neither standards nor premarket scientific review. FDA has already conducted an inventory of medical devices and initiated classification into categories. Legislation giving FDA authority to establish standards and require premarket testing of medical devices is expected to pass Congress and become law in 1975.