The Medical Devices Introductory Course 2020

Regulatory Agency

Food & Drug Administration

www.fda.gov

The Organisation for Professionals in Regulatory Affairs

Regulatory Agency:

• FDA provides federal oversight of food, drugs, devices, biologics, combination products and other health related products in the US • Established originally in 1862 as the Division of Chemistry in the US Department of Agriculture, renamed FDA in 1930, and first introduced the Food & Drugs Act in 1906, the Food, Drug & Cosmetic Act (FD&CA) in 1938 and the Medical Device Amendments Act in 1976 • The FDA includes the following centers and offices relevant to medical devices and related products: • Center for Devices & Radiological Health (CDRH) • Center for Biologics Evaluation & Research (CBER) • Center for Drug Evaluation & Research (CDER) • Office of Combination Products (OCP)

The Organisation for Professionals in Regulatory Affairs