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Fewer Device Submissions Sought In Subcommittee-Passed 'Cures' Bill

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.

21st Century Cures legislation approved in the House Energy & Commerce Health Subcommittee fleshes out provisions intended to reduce the number of FDA premarket submissions from device companies, including a measure allowing third-party quality systems certifications to replace certain premarket submissions and a provision pressing FDA to identify more devices that could be exempted from the 510(k) process.

The subcommittee approved the latest Cures draft in a voice vote at a May 14 markup, sending it up for consideration by the full committee the week of...

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