Question:

What is the IRB’s role in making the nonsignificant risk device determination?  Does the IRB review a sponsor’s determination prior to initiation of the study?  If so, what information does the sponsor need to submit to the IRB? 
– Researcher, Medical Device Company

Response:

Clinical trials of significant risk (SR) medical devices require submission of an IDE application to the FDA for approval before beginning your study.  Certain devices are deemed nonsignificant risk (NSR) by the FDA and do not require an IDE submission prior to enrolling subjects in the study.  FDA guidance includes an extensive list of examples that is useful in guiding SR and NSR decisions. 

The FDA requires the IRB to make an SR/NSR determination at the time of initial review of a study (unless the FDA has already made a determination). The initial application to the IRB needs to include the sponsor’s risk assessment and the rationale used by the sponsor in making its SR/NSR determination.

The IRB is required to review “the description of the device, reports of prior investigations conducted with the device, the proposed investigational plan, and subject selection criteria” along with the sponsor’s rationale for making its SR/NSR determination.