The Investigational Device Exemption (IDE) Workshop

Apr 11

This event has passed.

Wednesday, April 11, 2018 - 9:00am to 12:00pm

Presenter

Kelly Lindblom, PhD, RAC & Sarah Gemberling, 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