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, April 11, 2018
Icon time
9:00 am - 12:00 pm
Icon speaker
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

Contact: Susan Nagorski