Event sponsored by:
Office of Regulatory Affairs and Quality
Biomedical Engineering (BME)
Duke Clinical and Translational Science Institute (CTSI)
Pratt School of Engineering
School of Medicine (SOM)
School of Nursing (SON)
Contact:
Susan NagorskiSpeaker:
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