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FDA Issues Proposed Rule to Further Regulate LDTs

If the agency has its way, existing LDT oversight under CLIA rules may come to an end before 2028

CEO SUMMARY: Publication of the FDA’s draft rule on LDT regulation starts the clock on public comment. The proposal seeks to clearly identify laboratory developed tests (LDTs) as in vitro diagnostic devices, which then places many of these tests under increased regulatory review. Clinical laboratory managers and pathologists have until Dec. 2 to submit comments …

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