Fewer Device Submissions Sought In Subcommittee-Passed 'Cures' Bill
This article was originally published in The Gray Sheet
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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A combined House/Senate "21st Century Cures" package will get a vote in the House on Nov. 30, and soon in the Senate. The medical innovation package includes a breakthrough device pathway that, in its current form, would allow 510(k), as well as PMA and de novo, devices to participate. The bill also provides a modest $500m to help support a range of additional FDA device and drug pathway streamlining reforms. Meanwhile, it would authorize $4.8bn for the Precision Medicine Initiative, a BRAIN Initiative, and for cancer "Moonshot" research funds at NIH.
Formal consultations between FDA's product centers are becoming more frequent, and they are often triggered by questions about human factors issues, says Office of Combination Products Director Thinh Nguyen.
But the April 29 updated draft of the broad-based House reform package for medical innovation is missing some significant items floated earlier this year, including a Medicare breakthrough device program, a revamp of diagnostics regulations and device supply-chain security reform.