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HHS ‘Stands Down’ FDA on Its Oversight of LDTs

With a 252-word statement on Aug. 19, HHS said lab-developed tests are not required to obtain an EUA

CEO SUMMARY: A directive from the federal Department of Health and Human Services (HHS) may have long-lasting implications for the federal Food and Drug Administration’s efforts to assert regulatory oversight of laboratory-developed tests (LDTs). In a statement last week, HHS said that labs “are not required” to obtain an FDA emergency use authorization or FDA clearance of LDTs. Clinical labs welcomed …

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