CDRH Industry: In Vitro Companion Diagnostic Devices - Guidance for Industry and FDA Staff

A guidance document titled In Vitro Companion Diagnostic Devices has recently been posted.  This guidance is intended to assist (1) sponsors who are planning to develop a therapeutic product1 (either a novel product or an existing product with a new indication) for which the use of an in vitro companion diagnostic device (or test) is essential for the therapeutic product’s safe and effective use and (2) sponsors planning to develop an in vitro companion diagnostic device that is intended to be used with a corresponding therapeutic product.  For more information, please see: http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/UCM262327.pdf