A sponsor's preliminary determination that a medical device study presents an NSR is subject to IRB approval. The effect of the IRB's NSR decision is important to research sponsors and investigators because significant risk (SR) studies require sponsors to file an Investigational Device Exemption (IDE) with FDA before they may begin. NSR studies, however, may begin as soon as the IRB approves the study. The sponsor, usually through the clinical investigator, provides the IRB with information necessary to make a judgment on the risk of a device study.
While the investigational plan and supporting materials usually contain sufficient information to make a determination, the IRB can request additional information if needed. If the IRB believes that additional information is needed, it may contact the sponsor directly, but it should keep the clinical investigator apprised of the request. While making the SR/NSR determination, any of the three parties may ask FDA to provide a risk assessment.
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