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• When the research involves the clinical investigation of drugs or biologics as a test article, the PI must provide documentation in the protocol whether the test article(s) for use is under an IND or provide written justification for why the test article(s) is exempt from the requirement for an IND. Unless the PI is making the case that the test article is exempt from requirements for an IND, the IRBO will not further process the submitted IRB application until a determination has been reached by the FDA that either: 1) the test article does not require an IND; or 2) the research being conducted under IND is safe to proceed, or 3) 30 days has elapsed since submission of the IND application to the FDA, and no clinical hold has been placed on the clinical investigation. The IRB may require that the PI get a determination from the FDA about need for an IND even if the PI provides information as to why they believe the test article is exempt from the FDA IND requirements.
• When the research involves the study of the safety or efficacy of an investigational device, the PI needs to provide documentation in the electronic IRB system supporting the sponsor's assessment of whether the device is exempt (21 CFR 812.2(c)^{Image Modified}) from the IDE requirements, or that the use of the device in the specific protocol constitutes a non-significant risk (NSR) or significant risk (SR). If a determination by the FDA has already been made as to whether the device is exempt, NSR or SR, documentation from the FDA must be submitted in the electronic IRB system prior to full board review. If the IRB requires the PI to submit to the FDA for a determination prior to reviewing any device study, FDA is the final arbiter as to whether a device study is exempt, SR or NSR. This response provided from FDA needs to also be uploaded into the electronic IRB system. If the device has been determined to be a significant risk device in the context of the protocol under review, the investigator must upload documentation from FDA of the approved IDE for the device.
• For additional information, see the section of this manual related to FDA regulated research.

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