In Vitro Diagnostic Submission Streamlined Guidance

FDA has issued a guidance, Investigational In Vitro Diagnostics in Oncology Trials: Streamlined Submission Process for Study Risk Determination, 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, nonsignificant risk, or exempt from investigational device exemption requirements. The document says that if the IVD in the trial is determined to be significant risk in the streamlined process, the sponsor may need to submit an IDE to the appropriate Center (CDRH or CBER) in addition to submitting an IND to the appropriate Center (CDER or CBER). “FDA encourages sponsors to use the streamlined process described in this guidance when possible to reduce administrative burden on sponsors and FDA and to maintain the current level of regulatory review,” the agency says.