Medical Devices
Public Workshop – Moving Forward: Collaborative Approaches to Medical Device Cybersecurity, January 20-21, 2016 -
Public Workshop – Moving Forward: Collaborative Approaches to Medical Device Cybersecurity, January 20-21, 2016 The First-ever FDA Patient Engagement Advisory Committee
- Bringing patients into the medical device regulatory process.
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CDRH Patient Engagement Registration and Listing
- All medical device establishments are required to pay the annual registration user fee and re-register their establishments (annual registration) by December 31st of each year.
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Device Registration and Listing
Navigate the Medical Devices Section
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Device Advice: Comprehensive Regulatory AssistanceHow to Market a Device, Postmarket Requirements, Compliance, Importing & Exporting, more...
Digital HealthCybersecurity, Health IT Risk-Based Framework, 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
News & Events (Medical Devices)Medical Device News, Videos, Workshops & Meetings
Resources for You (Medical Devices)Consumers, Health Care Providers, Regulated Industry
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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
- CDRHLearn: Announcing Seven New Medical Device Education Modules
- Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling - Guidance for Industry and FDA Staff (PDF - 1.3MB)
Recommendations for a National Medical Device Evaluation System: Strategically Coordinated Registry Networks to Bridge the Clinical Care and Research - August 2015 (PDF - 2.3MB)- CDRH Customer Service - Please take our survey
Advancing precision medicine by enabling a collaborative informatics community
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Contact FDA
Office of Communication and Education
Center for Devices and Radiological Health
Food and Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993