Shortened ‘Cures’ Draft Retains Breakthrough Pathway, Device Reforms
This article was originally published in The Gray Sheet
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.
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The Senate HELP Committee voted March 9 in favor of a breakthrough device provision, watered down from a version approved in the House last year. Other bills voted out of committee include a combination products reform measure, the digital-health focused MEDTECH Act, and four others. Senators are still debating whether NIH and FDA should get additional funds to cover the cost of the bills, which will be wrapped up into a broader package before Senate floor debate.
A run-down of key provisions impacting the medical device and diagnostics industry in the 21st Century Cures legislation, which passed the House by a 344-77 vote July 10.
FDA will host a public meeting July 13 to hear public input in advance of agency-industry negotiations to reauthorize the device user-fee program. Industry appears to feel better about the device-review program than it did during the prior user-fee program, but what the top issues will be during negotiations this time around remain to be seen. Ongoing reform efforts in Congress will impact the process.