With James Flaherty, Zachary Gerson, Paul Kim
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."