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Device Advice

Device Advice is CDRH`s self-service site for medical device and radiation emitting product information. It is an interactive system for obtaining regulatory information concerning medical devices.

Medical Device Regulations


Premarket Information

Premarket Submissions

Postmarket Information

Overview of Regulations


Guidance Documents

CDRH Databases

Code of Federal Regulations

International Information

Consumer Information

Is Your Product Regulated?

Classify Your Device

How to Market Your Device

510(k)/GMP Exemption

Device Labeling

Premarket Notification 510(k)

Investigational Device Exemption (IDE)
for Clinical Studies

Premarket Approval (PMA)

Humanitarian Device Exemption (HDE)

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

Radiation Emitting Products

Does Your Product Emit Radiation?

Updated September 2, 2008

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