US FDA — Center for Devices and Radiological Health (CDRH)
Silver Spring, MD, United States
Regulatory & StandardsRegulatory Authorities
US regulator for medical devices and radiation-emitting products, responsible for 510(k) clearance, De Novo, PMA approval and post-market surveillance.
- Category
- Regulatory & Standards
- Type
- Regulatory Authorities
- Country
- United States
- Region
- North America
- Headquarters
- Silver Spring, MD
- Website
- fda.gov
510(k)PMApremarketpost-market