FDA’S Medical Device Standards Policy

Abstract

During 1980 the Food and Drug Administration (FDA) published a proposed voluntary standards policy, but as a result of the public comments received, the Agency may make major changes in its thrust. This presentation first reviews the mandatory standards process specified in the 1976 medical device amendments to the Food, Drug, and Cosmetic Act. It then summarizes the proposed voluntary standards policy published in the Federal Register, February 1, 1980, and the public comments received regarding that proposal. It concludes with possible changes to the voluntary standards policy as a result of those comments and their effect on the FDA medical device standards program for fiscal 1981.