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CDRH Can’t Rely On ‘Network of Experts’ Due To Confidentiality Concerns

CDRH Director Jeff Shuren told a Senate panel April 28 that an obstacle to getting outside expertise on innovative devices to gain the know-how to appropriately review them is companies’ confidentiality concerns, and inability of firms to share access to their proprietary data.

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 his counterpart in FDA’s drug office, Janet Woodcock, could advise...

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