Regulatory issues of the Food and Drug Administration∗

The mission of the US Food and Drug Administration (FDA) is to promote and protect public health. Among the numerous ways the FDA seeks to accomplish this mission is through regulatory supervision of medical drugs, devices, and biologics that are clinically evaluated and granted market entry into the USA. While the FDA’s regulatory history of medical drugs is well established over the course of 100 years, triggered by the passage of the Federal Food and Drugs Act of 1906, the FDA’s history of regulation of medical devices is much shorter, and was initiated with the passage of the Medical Device Amendments on May 28, 1976.