LDT UPDATE W/STACI KEARNEY (ELEVATION STRATEGIC CONSULTING)
Beyond the Scope
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Regulating Laboratory Developed Tests (LDTs)
This chapter explores the regulatory landscape for laboratory developed tests (LDTs), detailing the FDA's updated framework that mandates LDTs be treated as medical devices. It discusses the challenges laboratories face in complying with both FDA and CLIA regulations while preparing for significant deadlines, including the critical May 2026 requirements. The conversation also emphasizes the importance of clear labeling and guidance to ensure user safety and effective communication with healthcare providers.
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