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Senate Bill Tackles 'Least Burdensome,' Centralized IRBs, CLIA Waivers

This article was originally published in The Gray Sheet

Executive Summary

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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