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...
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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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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 alerts health care providers about potential risks with fluid-filled intragastric balloons
Potential Problems with Battery-Powered Mobile Medical Carts in Health Care Facilities that May Result in Fire: Letter to Health Care Professionals - List of Recalls
Safety Communications Medical Device Reporting (MDR)
Approvals & Clearances
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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