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 Cures Act passed by the House in 2015 (Also see...
Read the full article – start your free trial today!
Join thousands of industry professionals who rely on Medtech Insight for daily insights
The UK has issued clearer guidance to help drug and medical device sponsors demonstrate how they intend to include a diverse and relevant range of participants in their clinical trials.
Moves are at last underway for a more specific focus on orphan and pediatric devices. They are a start; but experts are calling for more to support this sector.