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Medical Devices Topics
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 AssistanceHow 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
Industry Assistance
CDRH Learn Guidance Documents (Medical Devices and Radiation-Emitting Products) How to Market Your Device FDA eSubmitter FDA-CMS Parallel Review Postmarket Requirements (Devices) - Industry Recall Guidance
Importing and Exporting Devices International Information (Devices) Classify Your Medical Device Bioresearch Monitoring Resolution of Differences of Opinion
Destacados
FDA announces public-private partnership to develop regulatory science that will speed patient access to new medical device technologies Improvements in Device Review: Results of CDRH's Plan of Action for Premarket Review of Devices National Medical Device Postmarket Surveillance Plan CDRH Mission, Vision and Shared Values CDRH 2013 Strategic Priorities