The Investigational Device Exemption (IDE) Workshop
Wednesday, April 11, 2018
9:00 am - 12:00 pm
Kelly Lindblom, PhD, RAC & Sarah Gemberling, PhD, RAC
Sponsor(s): School of Medicine - Regulatory Affairs, Biomedical Engineering (BME), Department of Surgery, Duke Center for Applied Genomics and Precision Medicine, Duke Clinical and Translational Science Award (CTSA), Duke Clinical and Translational Science Institute (CTSI), Duke Clinical Research Institute (DCRI), Duke Office of Clinical Research (DOCR), MEDx, Office of Research Administration (ORA), Office of Research Support (ORS), Pratt School of Engineering, School of Medicine (SOM), and School of Nursing (SON)
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
Contact: Susan Nagorski
