Medical Devices
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Medical Device SafetyAlerts & Notices, Recalls, Report a Problem, MedSun, Emergency Situations
Device Advice: Comprehensive Regulatory AssistanceHow to Market a Device, Postmarket Requirements, Compliance, Importing & Exporting, more...
Digital HealthCybersecurity, Mobile Medical Applications, Wireless Medical Devices
Applied Mechanics, Biology Chemistry & Materials Science, Biomedical Physics, Imaging Diagnostics & Software Reliability.
International ProgramsInternational Medical Device Regulators Forum, Medical Device Single Audit Program Pilot
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Industry Assistance
Device Advice: Comprehensive Regulatory Assistance CDRH Learn Medical Device Webinars and Stakeholder Calls - Premarket Requirements (How to Market Your Device)
Postmarket Requirements (Devices) Importing and Exporting Devices Classify Your Medical Device Guidance Documents (Medical Devices and Radiation-Emitting Products) FDA eSubmitter
Spotlight
Recalls & Alerts
- FDA Warns Health Care Providers Against Relying Solely on Zika Virus Serological IgM Assay Results; Reminds them to Wait for Confirmatory Test Results Before Making Patient Management Decisions
- Infections Associated with Reprocessed Flexible Bronchoscopes
- List of Recalls
Safety Communications Medical Device Reporting (MDR)
Approvals & Clearances
FDA permits marketing of new tissue expander for women undergoing breast reconstruction following mastectomy FDA expands indication for continuous glucose monitoring system, first to replace fingerstick testing for diabetes treatment decisions Recently-Approved Devices 510(k) Clearances PMA Approvals
Tools & Resources
Contact FDA
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