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The Investigational Device Exemption (IDE) Workshop

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Friday, February 17, 2023
12:00 pm - 2:00 pm
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

Contact: Susan Nagorski