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Shuren In The Lion’s Den: Device Center Chief Defends LDT Plan At Clinical Lab Meeting, Fields Wide Array Of Questions

This article was originally published in The Gray Sheet

Executive Summary

FDA device center Director Jeff Shuren explained and defended fine points of FDA’s proposed laboratory-developed test framework before some of his sharpest critics: members of the American Clinical Laboratory Association, who face an entirely new regulatory scheme once the LDT proposal is finalized.


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