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Attorneys Assess Impact of FDA’s Final LDT Rule

Some lab clients already signaling concerns that compliance costs will end their LDT offerings

CEO SUMMARY: Publication of the Food and Drug Administration’s final rule on laboratory developed tests (LDTs) is already causing some labs to consider withdrawing their existing LDTs because of compliance costs. Two experienced lab industry attorneys discuss aspects of the LDT rule and what they hear from their clinical laboratory clients. THROUGHOUT THE CLINICAL LABORATORY …

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