On July 31, 2014, the Food and Drug Administration (FDA) released a final guidance entitled “In Vitro Companion Diagnostic Devices: Guidance for Industry and Food and Drug Administration Staff” (the Final Guidance). The Final Guidance explains FDA’s views on development, review, and authorization of in vitro diagnostic (IVD) devices that provide essential information for the safe and effective use of a therapeutic product—called IVD companion diagnostic devices—and is relevant to sponsors of both therapeutic products and diagnostic devices.
As described in the Final Guidance, IVD companion diagnostic devices are part of a growing trend to personalize therapies for individual patients. With the emerging understanding of the human genome and advances in molecular diagnostics, IVD companion diagnostic devices offer the promise of tailoring therapies to the unique attributes of patients, such as identifying which patients are most likely to benefit or which patients are more likely to have adverse reactions to a particular drug therapy (among other possible uses). Over the past several years, FDA has approved numerous drugs or biologics with corresponding IVD companion diagnostic devices. FDA’s Final Guidance follows a Draft Guidance issued in July 2011, as well as a Draft Concept Paper issued in 2005.
Like the 2011 Draft Guidance on this topic, the Final Guidance provides that an IVD companion diagnostic device and corresponding therapeutic product should be approved or cleared contemporaneously “in most circumstances.” It also discusses FDA’s views on labeling and investigational requirements for these products.
The Final Guidance reflects limited, but potentially significant, changes from the Draft Guidance. To read more about these changes and other features of the Final Guidance, see our client alert.