Medical Devices
CDRH Preliminary Internal Evaluations
Reports on the 510(k) program and the use of science in regulatory decision making.
FDA's Role in Fostering the Development of Better Medical Devices
Message from Center Director Jeff Shuren, M.D., J.D.
Approvals & Clearances, Home Use, Surgical, Implants & Prosthetics, In Vitro Diagnostics, more...
Medical Device SafetyAlerts & Notices, Recalls, Report a Problem, MedSun, Emergency Situations
Device Advice: Device Regulation and GuidanceHow to Market a Device, Postmarket Requirements, Compliance, Importing & Exporting, more...
Chemistry & Materials Science, Solid & Fluid Mechanics, Imaging & Applied Mathematics, Electrical & Software Engineering, more...
News & Events (Medical Devices)Medical Device News, Videos, Workshops & Meetings
Resources for You (Medical Devices)Consumers, Health Care Providers, Regulated Industry
Program Areas
Industry Assistance
CDRH Learn Guidance Documents (Medical Devices and Radiation-Emitting Products) How to Market Your Device Postmarket Requirements (Devices) Importing and Exporting Devices International Information (Devices) Device Classification Bioresearch Monitoring FDA eSubmitter Resolution of Differences of Opinion
Spotlight
Recalls & Alerts
Approvals & Clearances
Tools & Resources
Contact Us
CDRH-Center for Devices and Radiological Health
- 1-800-638-2041
- 301-796-7100
Food and Drug Administration
10903 New Hampshire Avenue
WO66-5429
Silver Spring, MD 20993