The Investigational Device Exemption (IDE) Workshop

February 17, 2023
12:00 pm to 2:00 pm
Zoom

Event sponsored by:

Office of Regulatory Affairs and Quality
Duke Clinical and Translational Science Institute (CTSI)
Pratt School of Engineering
School of Medicine (SOM)

Contact:

Susan Nagorski

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Speaker:

Kylie Opel, JD and David Jensen, PhD, RAC
-Discuss FDA's approach to regulation of devices in clinical studies and for marketing -Provide guidance on when the IDE regulations apply and discuss possible exemptions -Review significant risk and non-significant risk device studies -Discuss the preparation, submission, and maintenance of IDE applications -Encourage participant discussion of case scenarios