FDA Proposes Optional Process for Oncology Therapeutic IVD Risk Factors in Clinical Trials

The FDA announced draft guidance introducing an optional submission process for determining the risks or non-risks of using an investigational in vitro diagnostic in a clinical trial involving an oncology investigational drug.

The submission process determines whether the use of an investigational IVD in a clinical trial for an oncology therapeutic is a significant risk, nonsignificant risk or exempt. The trial may require an investigational device exemption approval if it is found to be a significant risk, the guidance stated, in addition to an investigational new drug application.

A single sponsor should be prepared to hold communications with the FDA about the IND, the guidance said, and should submit information about the oncology development program to either CBER or CDER so those centers can consult CDRH to determine its risk factor.