The Investigational Device Exemption (IDE) Workshop

Wednesday, June 14, 2017 - 9:00am to 12:00pm

Trent Semans Center for Health Education - Great Hall

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Sarah Gemberling, PhD, RAC and Kelly Lindblom, PhD


This workshop will: - 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

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