Office of Regulatory Affairs and Quality - Investigational Device Exemption (IDE) Workshop

Jun 13

Tuesday, June 13, 2017

1:00 pm - 4:00 pm
Trent Semans Center for Health Education - Great Hall


Sarah Gemberling, PhD, RAC and Kelly Lindblom, PhD

*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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Perry, Audrey

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