Medical Devices
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Approvals & Clearances, Home Use, Surgical, Implants & Prosthetics, In Vitro Diagnostics, more...
Medical Device SafetyAlerts & Notices, Recalls, Report a Problem, MedSun, Emergency Situations
Device Advice: Comprehensive Regulatory AssistanceDevice Advice, FDA-CDRH's webpage for comprehensive regulatory education.
Digital HealthInformation about CDRH's Digital Health Program
Science at CDRH includes laboratory and field research in the areas of physical, life, and engineering sciences as well as epidemiological research in postmarket device safety.
International ProgramsInternational Medical Device Regulators Forum, Medical Device Single Audit Program Pilot
News & Events (Medical Devices)Medical Device News, Videos, Workshops & Meetings
Resources for You (Medical Devices)Information of special interest to specific audiences and stakeholders.
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Industry Assistance
Device Advice: Comprehensive Regulatory Assistance CDRH Learn Recent Final Medical Device Guidance Documents Recent Draft Medical Device Guidance Documents - Premarket Requirements (How to Market Your Device)
Postmarket Requirements (Devices) Importing and Exporting Devices Classify Your Medical Device FDA eSubmitter
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Recalls & Alerts
Approvals & Clearances
Useful Information
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Division of Industry and Consumer Education
CDRH-Center for Devices and Radiological Health
Food and Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993