Review the FDA Guidance titled Significant Risk and Nonsignificant Risk Medical Device Studies. The guidance document provides definitions and examples of Significant Risk (SR) and Nonsignificant Risk (NSR) studies.
The sponsor-investigator makes the initial risk determination for the proposed study and presents it to the IRB. The IRB then reviews the sponsor-investigator’s risk determination and agrees or disagrees. FDA is available to help the sponsor-investigator and the IRB in making the determination. If needed, FDA is the final arbiter.
Sponsors of an SR study are encouraged to contact FDA to obtain further guidance prior to the submission of an IDE application. This will be especially beneficial to new sponsors who have not previously had contact with the agency and for sponsors proposing to study new technologies or new uses for existing technologies. The pre-IDE Program is primarily designed to benefit the IDE sponsor. By allowing the sponsor to obtain early FDA input on selected (by the sponsor) sections of the IDE application, FDA hopes that the initiation of clinical trials will be facilitated.
This communication may take the form of telephone conference calls, video conferences, or face-to-face discussions. The pre-IDE Program is intended as a way for sponsors to obtain preliminary comments on their pre-clinical data (bench/animal testing) or the investigational plan (clinical protocol) in a timely manner. It will also allow FDA personnel to familiarize themselves with the new technologies. The sponsor should contact the Office of Device Evaluation (ODE) reviewing division directly or may contact the IDE staff for assistance:
Investigational Device Exemptions Program
Office of Device Evaluation
Center for Devices and Radiological Health
10903 New Hampshire Avenue
Silver Spring, MD 20993-0002