ABSTRACT
The Food and Drug Administration (FDA) promulgated the good manufacturing practices (GMPs) for medical devices regulations in 1978, drawing authority from the Medical Devices Amendments to the Federal Food, Drug, and Cosmetic (FD&C) Act of 1976. The GMP regulations represented a total quality assurance program intended to control the manufacture and distribution of devices. It allows the FDA to periodically inspect medical device manufacturers for compliance to the regulations.
