The Investigational Device Exemption (IDE) Workshop
Wednesday, June 14, 2017
9:00 am - 12:00 pm
Sarah Gemberling, PhD, RAC and Kelly Lindblom, PhD
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)
Cost: Free but REGISTRATION REQUIRED
This workshop will:
- 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
Type: WORKSHOP/SHORT COURSE
