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CDRH Learn is the FDA’s Center for Devices and Radiological Health (CDRH) web page for multimedia industry education and provides free learning modules describing many aspects of medical device and radiation-emitting product regulations, covering both premarket and postmarket topics.

New modules were added on September 30, 2019:

Start Here/The Basics! – (New modules 9/30/19)
MDUFA Small Business Program, Registration and Listing

How to Study and Market Your Device – (New modules 9/30/19) 510k, De Novo, IDE, PMA, HUD/HDE, Q-Submissions, Standards, Classification

Premarket Approval Application (PMA)


Categories FDA Regulatory
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