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October 2014—The Food and Drug Administration’s plan to subject many laboratory-developed tests to a new layer of regulatory requirements over the course of the next decade is drawing sharply contrasting reactions from stakeholders who view it as either an essential step to improve patient safety or a hindrance that will stifle diagnostic innovation and test improvement.

Despite that fundamental disagreement on the policy’s substance, there does seem to be consensus among informed observers that the FDA is determined to take action, that legislative intervention to block the agency faces long odds, and that the agency’s final guidance will create a regulatory challenge for labs unrivaled by anything out of Washington since CLIA ’88.

The FDA framework was unveiled in detail July 31 as part of a statutorily required notification to Congress 60 days prior to publication as a draft guidance. The agency on Oct. 3 gave notice in the Federal Register that the draft guidance was publicly available. The 41-page document—“Draft Guidance for Industry, Food and Drug Administration Staff, and Clinical Laboratories: Framework for Regulatory Oversight of Laboratory Developed Tests (LDTs)”—can be found at http://j.mp/ldtdraft.

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