Fewer Device Submissions Sought In Subcommittee-Passed 'Cures' Bill
This article was originally published in The Gray Sheet
Executive Summary
The House Energy & Commerce Health Subcommittee moved the 21st Century Cures bill forward in a May 14 mark. The legislation includes a newly fleshed-out measure allowing third-party quality systems certifications to replace certain PMA supplements, and another focused on exempting more devices from 510(k)s.
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