Multiple bills focused on accelerating the path to market for devices will join safety legislation reforming the regulation of duodenoscopes in a slate of Senate bills that HELP Committee Chairman Lamar Alexander said will receive hearings in February, March and April. The legislation-by-legislation approach in the Senate differs from the broad-based 21st Century Cures package that advanced in the House.

Senate HELP Ranking Member Sen. Patty Murray in a staff report criticizes FDA and manufacturers for reacting slowly to duodenoscope contamination incidents in 2013. The report says FDA needs a more robust device surveillance system and calls for more attention to 510(k) modification policies. Murray is a key partner in ongoing Senate work to produce a so-called "medical innovation" bill.

Both Democratic and Republican staffers on key congressional health committees say that members pushing forward a Senate “medical innovation” bill and backing “Cures” legislation in the House will not interfere with FDA’s proposed plan to regulate laboratory developed tests before the guidance is made final.