FDA Draft Guidance on Investigational In Vitro Diagnostics (IVDs) Used in Clinical Investigations of Therapeutic Products

To: All registered in vitro diagnostic (IVD) manufacturers and importers Subject: FDA Draft Guidance on Investigational In Vitro Diagnostics (IVDs) Used in Clinical Investigations of Therapeutic Products Today’s Federal Register announces availability of the draft guidance, “Investigational IVDs Used in Clinical Investigations of Therapeutic Products.” This guidance: describes when Investigational Device Exemption (IDE) regulation may apply to certain clinical investigations of therapeutic products; describes certain regulatory requirements sponsors should be aware of as they develop and conduct investigations; provides recommendations for determining the risk of investigational in vitro diagnostics (IVDs); provides recommendations for institutional review boards (IRBs) in reviewing such investigations; and provides recommendations for content to provide in an IDE application, when required. The FDA believes sharing this information will assist manufacturers using investigational IVDs in clinical investigations of therapeutic products and IRBs that review such investigations in complying with the IDE regulation. We welcome your comments and suggestions regarding investigational IVDs used in clinical investigations of therapeutic products. The comment period for the Federal Register notice  will be open for 90 days. Please submit comments no later than March 19, 2018. Instructions for submitting comments can be found in the Federal Register under docket number FDA-2017-N-6356. Thank you, Food and Drug Administration Center for Devices and Radiological Health