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FDA & CMS Issue Letter, Agree on LDT Oversight

It is a public statement that the two agencies are in agreement regarding FDA oversight of LDTs

CEO SUMMARY: With the release of a public statement about the oversight of LDTs on Jan. 24, 2024, officials at both the Food and Drug Adminstration and the Centers for Medicare and Medicaid Service went on record that both agencies are aligned in the specific roles each agency should have in the review and oversight …

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