House Set To Vote On Cures Nov. 30; Latest Version Includes 510(k)s In Breakthrough Pathway

Executive Summary

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.