Factors to Consider When Making Benefit-Risk Determinations for Medical Device Investigational Device Exemptions: Guidance for Investigational Device Exemption Sponsors, Sponsor-Investigators and Food and Drug Administration Staff

Issue Date: January 13, 2017
Issued by: Center for Devices and Radiological Health
Topic(s): Premarket, Clinical – Medical, Investigational Device Exemption (IDE)
Status: Final

Factors to Consider When Making Benefit-Risk Determinations for Medical Device Investigational Device Exemptions: Guidance for Investigational Device Exemption Sponsors, Sponsor-Investigators and Food and Drug Administration Staff

FDA is committed to improving U.S. patient access to new devices by strengthening and streamlining the clinical trial enterprise so that medical device clinical trials are conducted in the U.S. in an efficient and cost-effective manner, while maintaining appropriate patient and research participant protections. The purpose of this guidance is to provide greater clarity for FDA staff and investigational device exemption (IDE) sponsors and sponsor-investigators1 regarding the principal factors that FDA considers when assessing the benefits and risks of IDE applications for human clinical studies.

Download the Guidance Document