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CADe retrospective MRMC study subject to (IDE) IRB NSR requirements ?

  • 1.  CADe retrospective MRMC study subject to (IDE) IRB NSR requirements ?

    This message was posted by a user wishing to remain anonymous
    Posted 05-Oct-2022 16:37
    This message was posted by a user wishing to remain anonymous

    Hi 
    Based on Clinical Performance Assessment CADe 510(k) Submissions Guidance,  and given that a device considers a retrospective
    Multiple-Reader, Multiple-Case (MRMC) clinical study. As per CFR PART 812. Do IRB NSR Requirements apply for this type of study? any guidance will be highly appreciated!


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