On December 18, 2017, FDA announced the availability of a new draft guidance, titled “Investigational IVDs Used in Clinical Investigations of Therapeutic Products.” The draft guidance is intended to inform both product sponsors and IRBs regarding the application of the Investigational Device Exemption (IDE) regulation to investigational in vitro diagnostic devices (IVDs) used in therapeutic product clinical trials. The guidance expands on elements of the agency’s July 2016 draft guidance document for product sponsors, titled “Principles for Codevelopment of an In Vitro Companion Diagnostic Device with a Therapeutic Product,” which we addressed in a previous blog post.
With the growing focus on personalized medicine, IVDs are increasingly used in clinical investigations of therapeutic products to guide the management of subjects in such investigations, for example, to select or classify subjects, assign subjects to therapeutic product arms or doses, or monitor responses to treatment. FDA stated that it was issuing the new draft guidance because the agency is concerned that sponsors and IRBs may not understand that the IVDs used in therapeutic product clinical trials are also often investigational and are subject to the IDE regulation in addition to the Investigational New Drug (IND) requirements applicable to the therapeutic product. The guidance clarifies that an investigational IVD is subject to the IDE regulation even if the therapeutic product is exempt from the IND regulation and even if the manufacturer does not intend to seek FDA clearance or approval for commercial distribution of the IVD.