FDA Issues New Guidelines for Approving Medical Devices

On July 25, 2014, the United States Food and Drug Administration issued new guidance regarding its 510(k) process, which is one of the processes by which manufacturers may obtain FDA approval for new medical devices.  The 510(k) process allows manufacturers to seek approval to market a new medical device based on the proposition that the new device is “substantially equivalent” to a previously approved and marketed device.  As part of this process, manufacturers are able to put forth less clinical evidence in regard to the new device, and to primarily rely on data regarding the previously approved device (or predicate device).

The FDA’s new guidance brings about several important changes, including the elimination of the “split predicate.”  A split predicate is when a manufacturer attempts to show that a new device has the same intended use as onepreviously marketed device and the same technological characteristics as another previously marketed device.  The new guidance concludes that “the use of a split predicate is inconsistent with the 510(k) regulatory standard.’’  The new guidance also introduces the idea of a “reference device,” which is a device that may be used to address specific scientific questions about a new device.  However, the reference device cannot act as a substitute for the predicate device.More information about the FDA’s updated 510(k) program can be found at:
http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/UCM284443.pdf