Event sponsored by:
Office of Regulatory Affairs and Quality
Pratt School of Engineering
School of Medicine (SOM)
Contact:
Susan NagorskiSpeaker:
Alysa Vereen, PharmD 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
Review case scenarios