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§ NORTH AMERICA
FDA
U.S. Food and Drug Administration
United States
The FDA is the primary regulatory authority for medical devices in the United States. Its Center for Devices and Radiological Health (CDRH) oversees premarket review, postmarket surveillance, and enforcement. The FDA processes approximately 4,000 510(k) submissions and 50 PMA applications annually, making it the most active device regulatory body globally.
DEVICE CLASSES
Class I, II, III
APPROVAL PATHWAY
510(k), PMA, De Novo, HDE
KEY REGULATORY FUNCTIONS
- ▸510(k) clearance and PMA approval
- ▸MAUDE adverse event database
- ▸FDA Enforcement Reports and recalls
- ▸De Novo classification
- ▸Breakthrough Device Designation
OFFICIAL WEBSITE
https://www.fda.gov →MedFlux monitors FDA regulatory changes, safety alerts, and market signals in real time — so your team never misses a critical update.
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