The House Energy and Commerce Committee has substantially trimmed down its “21st Century Cures” reform wish list in an updated legislative proposal posted April 29, but significant device regulatory reforms, including a breakthrough device priority review program, remain in play.
Shortened ‘Cures’ Draft Retains Breakthrough Pathway, Device Reforms
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. A significant new addition to the legislative proposal would double the number of people that could be treated per year with a humanitarian device exemption product from 4,000 to 8,000.
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