publication date: Oct. 11, 2019

Drugs & Targets

FDA publishes guidance on submission process for determining risk of investigational in vitro diagnostics

FDA has published a guidance for industry on an optional streamlined submission process for determining whether investigational in vitro diagnostic in clinical trials for an oncology therapeutic is considered significant risk, nonsignificant risk, or exempt from investigational device exemption requirements.

If the IVD in the trial is determined to be SR in the streamlined process, the sponsor may need to submit an IDE to the appropriate center, either Center for Devices and Radiological Health or Center for Biologics Evaluation and Research, in addition to submitting an investigational new drug application to the appropriate center, either Center for Drug Evaluation and Research or CBER.

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