Frequently Asked Questions

What should IRBs do when reviewing the types of IVD studies that are the focus of this guidance?

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Compliance & Regulatory: MedTech

To facilitate IVD device development, FDA intends to exercise enforcement discretion toward IRBs who approve IVD investigations that are consistent with the factors, with respect to the IRB's duties under 21 CFR part 56 regarding informed consent for those studies. (Noncompliance with requirements of 21 CFR part 56 not related to informed consent is not subject to enforcement discretion.) FDA recommends that the IRB review the sponsor's documentation regarding the factors described, including the policies and procedures followed by the specimen provider to ensure that the subject cannot be identified. IRBs should apply existing FDA regulations, including all informed consent requirements, to any other investigational IVD study. FDA encourages IRBs to contact FDA if they have questions about the guidance or a specific study under review.

The factors being mentioned can be viewed here.