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The Investigational Device Exemption (IDE) Workshop

Feb 17

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

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Presenter

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
susan.nagorski@duke.edu