Amy Dow

Amy Dow

Epstein Becker & Green

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A Final Rule Bites the Dust, Part II: FDA Gives up on Regulating LDTs as Medical Devices

As the song goes, the Food and Drug Administration’s (“FDA’s”) 2024 Final Rule regulating laboratory-developed tests (“LDTs”) as medical devices (“Final Rule”), is not merely dead—it’s really most sincerely dead....more

6/6/2025  /  Constitutional Challenges , Food and Drug Administration (FDA) , Judicial Authority , Laboratory Developed Tests , Medical Devices , Regulatory Authority , Regulatory Reform , Rulemaking Process , Statutory Interpretation
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