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摘要：

To describe the procedures for Institutional Review Board (IRB) review of medical device clinical investigations including those exempt from, or subject to Investigational Device Exemption (IDE) regulations (i.e., Full IDE, Abbreviated IDE and Treatment IDE) and compassionate use of an investigational device. GENERAL DESCRIPTION The Food and Drug Administration (FDA) IDE regulation [21 CFR 312] describes three types of device studies: 1) exempt studies, 2) significant risk (SR) and 3) nonsignificant risk (NSR) studies. For studies that do not meet the criteria for exemption from IDE requirements, the sponsor and the IRB categorize the device investigation as either SR or NSR. The sponsor makes the initial determination of risk. The principal investigator (PI) submits the proposed study to a convened IRB for formal determination of the appropriate category. Unless the study is exempt from IDE requirements, a SR device study must be conducted under an FDA approved IDE and a NSR device study may be conducted under an abbreviated IDE with the IRB acting as surrogate for the FDA. An exemption from the IDE requirement is not an exemption from the requirement for prospective IRB review or informed consent. In the event of

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