US Food and Drug Administration (US FDA)

What is the FDA? The US Food and Drug Administration (FDA) is the federal regulatory authority responsible for protecting public health in the United States by ensuring the safety, effectiveness, and quality of a wide range of health-related products. Its jurisdiction extends across medical devices, in vitro diagnostics (IVDs), pharmaceuticals, vaccines, biologics, blood products, food, dietary supplements, cosmetics, radiation-emitting electronic products, and tobacco products. The FDA operates under the Department of Health and Human Services and derives its authority primarily from the Federal Food, Drug, and Cosmetic Act of 1938, along with subsequent amendments. The agency traces its roots back to 1906 with the passage of the original Pure Food and Drugs Act. What does the FDA do? The FDA regulates health products throughout their lifecycle to safeguard public health. This includes pre-market review of drugs, biologics, and medical devices to evaluate safety and efficacy before they can be marketed. It enforces Good Manufacturing Practices (GMP) by inspecting facilities in the U.S. and abroad to ensure compliance with quality standards. Once products are on the market, the FDA monitors their performance through post-market surveillance, adverse event reporting systems, recalls, and safety alerts. The agency also regulates clinical trials, oversees product labeling and advertising, and works with U.S. Customs and Border Protection to control the import and export of regulated goods. Beyond enforcement, the FDA issues regulations, guidance documents, and scientific standards to support innovation and regulatory consistency.