Investigational In Vitro Diagnostics Used in Clinical Investigations of Therapeutic Products; Draft Guidance for Industry, Food and Drug Administration Staff, Sponsors, and Institutional Review Boards; Availability

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The Food and Drug Administration (FDA or Agency) is announcing the availability of the draft guidance entitled "Investigational IVDs Used in Clinical Investigations of Therapeutic Products." This draft guidance is intended to assist sponsors of clinical investigations of therapeutic products that also include investigational in vitro diagnostics (IVDs) and institutional review boards (IRBs) that review such investigations in complying with the Investigational Device Exemption (IDE) regulation. This draft guidance is also intended to assist FDA staff participating in the review of these investigations. This draft guidance is not final nor is it in effect at this time.