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Scope Firms, FDA Faulted In 300-Page Senate Report Seeking Device Reforms

This article was originally published in The Gray Sheet

Executive Summary

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.

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