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Innovation Bill Scorecard: Device, Diagnostic Provisions In Senate And House

This article was originally published in The Gray Sheet

Executive Summary

On April 6, the Senate HELP Committee finished the last of three markup sessions on medical innovation bills designed to be the Senate's version of the 21st Century Cures Act, which passed the House last July. Check out this Gray Sheet chart that lists device-relevant bills that have passed through the HELP Committee aligned with similar House Cures' provisions.

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

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.

Congress Likely To Vote On Cures Bill Package After Thanksgiving

Back-to-back votes from the House and Senate on matching medical innovation bills, including provisions streamlining FDA device oversight, is expected the week of Nov. 28, with "pay-fors" expected to come from the Strategic Petroleum Reserve fund and the Prevention and Public Health Fund.

Medical Innovation Bills On Fast Track In Congress, But Some Barriers Remain

With an all-Republican House, Senate and administration lined up to lead the government following the 2016 elections, the path is clear for passage of a set of FDA reforms to ease device approvals embedded in a combined House 'Cures' and Senate medical innovation package. It could even happen over the upcoming lame-duck session, before the new administration and Congress take over. But controversy around price-gouging by drug firms still could stymie quick Cures bill passage, an industry attorney predicts. Meanwhile, medtech industry groups plan to seize on the Trump victory as a means to achieve permanent device tax repeal.

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