In response to protracted public and political criticism of the Food and Drug Administration’s (FDA or Agency) regulation and review of medical devices under the premarket notification, or 510(k), process, the FDA’s Center for Devices and Radiological Health (CDRH or Center) yesterday released a set of proposed reforms to better “foster medical device innovation and assure the safety and effectiveness of medical technology.” 1

In a cover letter accompanying the proposals, Center Director Jeffrey Shuren acknowledged that CDRH has received complaints from regulated industry about its “unpredictable, inconsistent and opaque” decision making, and has also faced accusations from consumer advocates that the 510(k) program is “[in]sufficiently robust to assure that some devices cleared under the program are safe and effective nor does it provide enough information on safety and effectiveness to make well-informed decisions.” 2