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

The LDT Final Rule Bites the Dust: Examining the Repercussions of the Federal Court’s Vacatur and What the Future May Hold

On March 31, 2025, Judge Sean D. Jordan of the U.S. District Court for the Eastern District of Texas ruled that the Food and Drug Administration (FDA) lacks the statutory authority to regulate laboratory developed tests...more

4/8/2025  /  Administrative Procedure Act , Appeals , Chevron Deference , Food and Drug Administration (FDA) , Judicial Authority , Loper Bright Enterprises v Raimondo , Medical Devices , Regulatory Authority , Statutory Interpretation
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