FDA
U.S. Food and Drug Administration (FDA)
About
The FDA Center for Devices and Radiological Health (CDRH) regulates medical devices sold in the United States. It oversees premarket review (510(k), PMA, De Novo), establishment registration, device listing, and post-market surveillance including MDR and recalls.
Regulatory Details
Regulatory FrameworkFDA 21 CFR Parts 800-1299
Device ClassificationClass I, Class II, Class III
Jurisdiction TypeNational
Country🇺🇸 United States
StatusActive