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

This article was originally published in The Gray Sheet

Executive Summary

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.

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