US FDA (US Food and Drug Administration)

The US Food and Drug Administration (FDA) is the federal regulatory authority responsible for ensuring the safety, effectiveness, and quality of 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. It enforces the Federal Food, Drug, and Cosmetic Act of 1938, along with subsequent amendments. FDA develops guidance documents to support regulatory consistency and publishes new regulations and rules in the Federal Register, which are codified in the Code of Federal Regulations (CFR) when they become final.

The Center of Devices and Radiological Health (CDRH) is the center within the FDA responsible for medical device oversight. This includes pre-market review of medical devices to evaluate safety and efficacy before they can be marketed. Most devices are required to submit a Premarket Notification 510(k) for review, depending on their risk classification. Most high-risk devices are required to submit a more extensive Premarket Approval (PMA).

It enforces Good Manufacturing Practices (GMP) by inspecting facilities in the US and abroad to ensure compliance with the Quality Management System Regulation (QMSR), which will apply from February 2, 2026. Once products are on the market, the FDA ensures 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 US Customs and Border Protection to control the import and export of regulated goods.

‍Website: US FDA
Address: 10903 New Hampshire Ave, Silver Spring, MD 20993
Phone: (800) 638-2041
Email: DICE@fda.hhs.gov