Skip to main content
Browse by:
GROUP

Effective March 10, 2020, all Duke-sponsored events over 50 people have been cancelled, rescheduled, postponed or virtualized.
Please check with the event contact regarding event status. For more information, please see https://coronavirus.duke.edu/events

The Investigational Device Exemption (IDE) Workshop

Event Image
Icon calendar
Wednesday, November 20, 2019
Icon time
9:00 am - 12:00 pm
Icon speaker
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

Contact: Susan Nagorski