Event sponsored by:
Office of Regulatory Affairs and Quality
Duke Clinical and Translational Science Institute (CTSI)
Pratt School of Engineering
School of Medicine (SOM)
Contact:
Susan NagorskiSpeaker:
Kylie Opel, JD 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