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The Investigational Device Exemption Workshop

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Friday, March 12, 2021
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9:00 am - 11:00 am
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Alysa Vereen, PharmD 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
Review case scenarios

Contact: Susan Nagorski