This section will help faculty navigate the process of developing a Sponsor-Investigator IDE. For a comprehensive introduction to device development, please refer to: Kahan, Jonathan. Medical Device Development: Regulation and Law. Needham, MA: Barnett International, 2009.
The information provided in the following links pertains to Class III devices, that is, devices with the greatest risk or those that have a new intended use or employ a new, unique technology. For additional information, please contact the ITHS Preclinical Research Development team directly.
View templates and guidance relevant to each step in the process. ITHS can review your application prior to submission.
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:
A fully developed protocol is the basis for both the IRB Application and the initial IDE submission:
An IDE application is considered approved 30 days after it has been received, unless FDA informs the sponsor otherwise.
An IDE may be approved, approved with conditions, or disapproved. In cases of disapproval, a sponsor has the opportunity to respond to the deficiencies and/or to request a regulatory hearing under 21 CFR Part 16
IDE holders are responsible for submitting supplemental applications, notifications, and reports in accordance with 21 CFR 812. All submissions should be submitted in triplicate to the project manager named in the IDE Acknowledgement Letter. Additional information can be found in the sections of 21 CFR 8 linked below and in “Guidance on IDE Policies and Procdures.”
IDE holders may wish to modify the study protocol or the device design during the course of a clinical study. Under 21 CFR 812.35 sponsors are required to:
IDE sponsor-investigators are required under 21 CFR 812.150 to submit the following reports:
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