FDA
Food and Drug Administration: The US federal agency responsible for regulating medical devices, drugs, and food safety.
The Food and Drug Administration oversees medical device clearances, approvals, and market enforcement in the United States. Its Center for Devices and Radiological Health (CDRH) manages premarket applications like 510(k), PMA, and De Novo, enforces 21 CFR regulations, and maintains post-market surveillance databases like MAUDE.