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Expert Analysis

FDA Regulation Of Laboratory Developed Tests: A Long Saga

By Gail Javitt, DLA Piper (December 15, 2016, 2:17 PM EST) -- The U.S. Food and Drug Administration's approach to laboratory developed tests (LDTs) has had more plot twists than — and has gone on nearly as long as — some of TV's most popular soap operas. In the latest turn of events, which aired shortly after the 2016 elections, the FDA announced that it would not be issuing final guidance documents that would have regulated LDTs as medical "devices," and the laboratories performing them as medical device "manufacturers."...

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