The Investigational Device Exemption (IDE) Workshop


event sponsored by

Office of Regulatory Affairs and Quality &

Duke Clinical and Translational Science Institute (CTSI), Pratt School of Engineering, and School of Medicine (SOM)


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


United States Focus, Lecture/Talk, Workshop/Short Course, and Research