FDA Streamlines Process for Investigation IVDs Used in Cancer Drug Trials

A new final guidance from the FDA allows some sponsors of oncology products to file a single application for use of an investigational diagnostic in their trial rather than filing for the drug and device components separately.

Under the new guidance, sponsors of trials combining a new oncology drug with a new in vitro diagnostic (IVD) device will submit an investigational new drug application to the CDER or CBER, including information about the investigational IVD in question.

CDER or CBER then will consult with CDRH to determine whether the IVD presents a “significant risk” and requires the sponsor to submit a separate application to CDRH for investigational device exemption.