humanitarian device exemption application

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Internal Emails Show FDA, Industry Jointly Framed 'Cures' Device Language

Joe Williams | Inside Health Policy | December 10, 2015

FDA and the largest medical device lobbying group worked together to develop proposed legislative language for most of the medical device provisions included in the House-passed 21st Century Cures bill, one of the largest FDA reform bills to pass the House in recent years, and are developing a synchronized regulatory strategy for the Senate version, according to internal emails and documents obtained by Inside Health Policy through the Freedom of Information Act...

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