ABSTRACT
In 1962, the Food and Drug Administration (FDA) began requesting safety and efficacy data on new drugs and cosmetics. Prior to 1976, the FDA had limited authority over medical devices under the Food, Drug, and Cosmetic Act of 1938. In 1976, with input from the Cooper Committee, the FDA created the Medical Device Amendments to the Federal Food, Drug and Cosmetic Act, which were subsequently signed into law. In 1978, with the authority granted the FDA by the amendments, the Good Manufacturing Practices (GMP) were promulgated. The GMP represents a quality assurance program intended to control the manufacturing, packaging, storage, distribution and installation of medical devices. Premarket notification is documentation submitted by a manufacturer that notifies the FDA that a device is about to be marketed. The FDA responds with an “order of concurrence” or nonconcurrence with the manufacturer’s equivalency claims.
