New USFDA draft Guidance on in-vitro Diagnostics in Oncology Trials

Comments and suggestions regarding this draft document should be submitted within 60 days of publication

The purpose of this guidance is to describe an optional streamlined submission process for determining whether use of an investigational in vitro diagnostic (IVD) in a clinical trial for an oncology therapeutic is considered significant risk (SR), non-significant risk (NSR), or exempt. If found to be SR, such a trial may require approval of an investigational device exemption (IDE) in addition to an investigational new drug application (IND). FDA encourages sponsors to use the streamlined process described in this guidance when possible to reduce administrative burden on sponsors and FDA and to maintain the current level of regulatory review.

Regardless of whether a study involving an investigational IVD is determined to be SR or NSR, it must follow the abbreviated requirements outlined in 21 CFR 812.2(b),3 including generating and retaining data that demonstrate analytical validation of the investigational IVD. Sponsors can contact CDRH directly with questions relating to analytical validation of the investigational IVD.

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