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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

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.

Before asking CDRH Director Jeff Shuren to step to the podium at the American Clinical Laboratory Association’s annual gathering, the group’s president kicked off the meeting by joking that bulletproof glass was installed between Shuren and the rapt clinical lab audience.

In return, Shuren jested: “But it’s actually a

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