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Regulatory Focus™ > News Articles > 2019 > 10 > FDA Finalizes Guidance on Streamlined IVD Reviews for Cancer Clinical Trials

FDA Finalizes Guidance on Streamlined IVD Reviews for Cancer Clinical Trials

Posted 09 October 2019 | By Zachary Brennan 

FDA Finalizes Guidance on Streamlined IVD Reviews for Cancer Clinical Trials

As part of a push to reduce administrative burdens, the US Food and Drug Administration (FDA) on Wednesday finalized guidance on an optional streamlined submission process for determining the risk of an investigational in vitro diagnostic (IVD) in a clinical trial where an investigational IVD is being co-developed with an oncology investigational drug.

The submission process, first proposed in draft guidance in April 2018, is meant to help sponsors determine if an IVD is a significant risk (SR), a nonsignificant risk (NSR) or exempt from investigational device exemption (IDE) requirements.

“Major changes from the draft to the final version included adding language to clarify that sponsors will receive significant risk determinations within the 30-day review period for the IND and to clarify that the streamlined submission process only applies to new INDs (not additional protocols added to an existing IND, or IND amendments) and adding the definition of noninvasive in 21 CFR 812.3(k) to the glossary,” FDA explained in the Federal Register on Wednesday.

A study involving an investigational IVD that is determined to be NSR must follow the abbreviated requirements outlined in 21 CFR 812.2(b), FDA says, noting that a study involving an investigational IVD that is determined SR requires an IDE application to be submitted and is subject to the full IDE requirements.

Under the streamlined process, FDA explains: “The sponsor should submit to the appropriate center (CBER or CDER) all information about the oncology codevelopment program (including information about the investigational IVD) in the trial protocol for the IND. As part of the IND review, CBER or CDER will consult with CDRH or CBER, as appropriate, and determine if the investigational IVD is SR, NSR, or exempt.” The guidance also includes several considerations for sponsors using this streamlined process.

In the traditional submission process, FDA notes, sponsors submit a study risk determination Q-submission to the appropriate center (CDRH or CBER) and an IND to the appropriate center (CBER or CDER).

“In the streamlined process, all information regarding the oncology codevelopment program (including investigational in vitro diagnostic information) is initially submitted to the IND,” FDA says.

Investigational In Vitro Diagnostics in Oncology Trials: Streamlined Submission Process for Study Risk Determination Guidance for Industry


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Tags: cancer, CDRH, FDA, guidance, IVD

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