While FDA’s device center has been trying to leverage data provided by an outside “network-of-experts” since late 2011, CDRH Director Jeff Shuren testified to a Senate panel April 28 he is sometimes blocked from using that data due to companies’ confidentiality concerns.
Senate Health, Education, Labor and Pensions Committee Chairman Lamar Alexander, R-Tenn., convened the hearing in part so that Shuren and...