MassDevice -- Center for Devices and Radiological Health director Dr. Jeffrey Shuren fires back at recent study from Stanford University on the costs associated with satisfying Food & Drug Administration rules during the 510(k) process. Center for Devices and Radiological Health director Dr. Jeffrey Shuren strongly refuted findings from a recently study that said more than three-quarters of the cost to bring a medical device from concept to the U.S. market is spent clearing regulatory hurdles.
