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).
FDA Issues New Guidelines for Approving Medical Devices
Aug 7, 2014 | Read Time: < 1 minute