The Investigational Device Exemption (IDE) Workshop
Wednesday, June 14, 2017 - 9:00am to 12:00pm
Wednesday, June 14, 2017 - 9:00am to 12:00pm
Trent Semans Center for Health Education - Great Hall
Presenter
Sarah Gemberling, PhD, RAC and Kelly Lindblom, PhD
Details
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