Six New Modules added to CDER Learn
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)
- Introduction to the Premarket Approval Application (PMA) Program
- Premarket Approval Application (PMA) Program: Postapproval Requirements
Q-Submissions
Categories FDA Regulatory