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The guidance describes an optional streamlined submission process for use of an investigational in vitro diagnostic in a clinical trial for oncology therapies.
FDA published guidance on Oct. 9, 2019 describing 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), nonsignificant risk (NSR), or exempt from investigational device exemption (IDE) requirements. According to FDA, a sponsor may need to submit an IDE to either the Center for Devices and Radiological Health (CDRH) or the Center for Biologics Evaluation and Research (CBER) if the IVD in the trial is determined to be SR, in addition to submitting an investigational new drug application (IND) to the Center for Drug Evaluation and Research (CDER) or CBER. FDA states that using the streamlined process may reduce administrative burden on sponsors and FDA.