On Wednesday, August 4, 2010, the Food and Drug Administration’s (FDA) Center for Devices and Radiological Health (CDRH) released for public comment two preliminary reports recommending steps to: (1) foster medical device innovation; (2) enhance regulatory predictability; and (3) improve patient safety. According to CDRH Director Jeffrey Shuren, MD, JD, the actions proposed in the reports represent “a blueprint for smarter medical device oversight” and are intended to advance CDRH’s responsibility to both protect and promote public health. The reports were prepared by two separate internal groups within CDRH, both convened in September 2009.