The Investigational Device Exemption (IDE) Workshop

November 20, 2019 - 9:00am to 12:00pm
Kelly Lindblom, PhD, RAC 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