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[Reference] [Medical Device] [FDA-CDRH] [European Union] [Health Canada] [ISO] [Organizations]

Center for Devices and Radiological Health / CDRH

Document Name

Medical Device Quality Systems Manual


Overview of Regulations


Guidance Documents

CDRH Databases

Code of Federal Regulations

International Information

Consumer Information

CDRH Learn

Premarket Information

Is Your Product Regulated?

Classify Your Device

How to Market Your Device

510(k)/GMP Exemption

Device Labeling

Premarket Submissions

Premarket Notification 510k

Investigational Device Exemption(IDE) for Clinical Studies

Premarket Approval (PMA)

Humanitarian Device Exemption (HDE)

Postmarket Information

Establishment Registration

Device Listing

Quality Systems for Manufacturing

Medical Device Reporting for Adverse Events

 Recalls/ Corrections and Removals

Importing Devices

Exporting Devices

Medical Device Tracking

Postmarket Surveillance Studies

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