Senate Bill Tackles 'Least Burdensome,' Centralized IRBs, CLIA Waivers
This article was originally published in The Gray Sheet
The targeted FDA Device Accountability Act mirrors select device sections of the House 21st Century Cures legislation seeking to strengthen the use of "least-burdensome" provisions, allow use of centralized IRBs for device trials and refining standards for diagnostic CLIA waivers.
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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.