Friday, April 25, 2025
12:00 pm – 2:00 pm
Zoom
Presenter: 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 • Encourage participant discussion of case scenarios
Contact
Susan Nagorski
susan.nagorski@duke.edu