House Set To Vote On Cures Nov. 30; Latest Version Includes 510(k)s In Breakthrough Pathway
• By Sue Darcey and David Filmore
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.
House and Senate lawmakers have released a compromise 21st Century Cures Act including a breakthrough device pathway and other device-related FDA and health-care policy reforms, in advance of planned vote in the House Nov. 30.
The latest version of the legislation, posted online Nov. 25, includes a combination of elements from the comprehensive 21St Century...
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