U.S. FDA — Medical Devices (CDRH)

The FDA's Center for Devices and Radiological Health (CDRH) regulates medical devices under the Federal Food, Drug, and Cosmetic Act (FD&C Act).

Device Classification

Class	Risk	Pathway
Class I	Low	510(k) exempt or 510(k)
Class II	Moderate	510(k) or De Novo
Class III	High	PMA

Structure

• Regulations (21 CFR) — Code of Federal Regulations
• Consensus Standards — FDA-recognized standards
• Guidance Documents — FDA guidance for industry

Key Resources

• CDRH Website
• 510(k) Database
• FDA Standards Database
• CDRH Guidance Documents