Safe Medical Devices Act of 1990

The Safe Medical Devices Act of 1990 (P.L. 101-629) was signed by President Rush on 28 November 1990. It is the first important device amendment to the federal Food, Drug, and Cosmetic Act since the Medical Device Amendments of 1976. The new law caps eight years of congressional review of implementation of the 1976 statute and gives to the Food and Drug Administration (FDA) significant new authority for regulating the safety and effectiveness of medical devices and diagnostic products. The 1976 device law established a regulatory system based on the degree of risk posed by a product, as classified by FDA. New high-risk products were subjected to a premarket procedure similar to that for new drugs. This procedure required FDA approval based on clinical experience before a device could be marketed. “Me-too” products and product modifications were not required to adhere to this process if the product as introduced or modified was substantially equivalent to a product on the market before the 1976 enactment date. High-risk products on the market prior to that date were “grandfathered” but were supposed to be subjected eventually to premarket approval requirements. All products, regardless of the category of risk, were subject to a variety of controls, chief of which were adherence to good manufacturing practices and reporting of defects related to product