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Medical Devices › Judicial Authority › Regulatory Authority

Epstein Becker & Green

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

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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

McGuireWoods LLP

Court Strikes Down FDA Rule Regulating Laboratory-Developed Tests

McGuireWoods LLP on

On March 31, 2025, the U.S. District Court for the Eastern District of Texas, in American Clinical Laboratory Association v. U.S. Food and Drug Administration, vacated the U.S. Food and Drug Administration’s (FDA’s) May 6,...more

Jones Day

Judge Blocks FDA Regulation of Laboratory-Developed Tests

Jones Day on

On March 31, 2025, a judge in the Eastern District of Texas struck down a 2024 Final Rule (the "Final Rule") by the Food and Drug Administration ("FDA") that exerted jurisdiction over the regulation of laboratory-developed...more

McCarter & English, LLP

Texas District Court Vacates FDA’s Final Rule Expanding Oversight to Laboratory Tests in Hospitals

McCarter & English, LLP on

In our May 2024 Healthcare Alert, we discussed a final rule published by the US Food and Drug Administration (FDA) amending its regulations to include in vitro diagnostic products (IVDs), even those manufactured in a...more

Mintz - Health Care Viewpoints

A Texas Federal Court Sides with Laboratories, But There May Be Unintended Consequences for FDA

Mintz - Health Care Viewpoints on

The obvious result of the legal shootout between the U.S. Food & Drug Administration (FDA) and clinical laboratory trade associations, the American Clinical Laboratory Association and the Association for Molecular Pathology,...more

Faegre Drinker Biddle & Reath LLP

Laboratory-Developed Tests (LDTs) Do Not Qualify as ‘Devices’ Under the Food, Drug and Cosmetic Act

Faegre Drinker Biddle & Reath LLP on

On March 31, 2025, in the U.S. District Court for the Eastern District of Texas vacated the Food and Drug Administration’s (FDA) final rule, in which FDA attempted to assert regulatory authority over laboratory-developed...more

Epstein Becker & Green

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

Epstein Becker & Green on

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

King & Spalding

FDA's LDT Rule Struck Down by Court: FDA Has Lost the Battle, But Is the War Over?

King & Spalding on

A court has struck down the Food and Drug Administration’s attempt to extend its regulatory authority to clinical laboratory testing services. On March 31, 2025, in the consolidated cases American Clinical Laboratory...more

Foley & Lardner LLP

Texas Court Vacates FDA’s Laboratory Developed Test (LDT) Final Rule

Foley & Lardner LLP on

A Texas judge for the U.S. District Court for the Eastern District of Texas issued a ruling on March 31, 2025, to vacate and set aside, in its entirety, the U.S. Food and Drug Administration’s (FDA) Final Rule titled Medical...more

Epstein Becker & Green

A Final Rule Bites the Dust: Federal Court Rules FDA Lacks Authority to Regulate LDTs

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The order is in, and the LDT Final Rule is out. In May 2024, the U.S. Food & Drug Administration (“FDA” or the “Agency”) published its Final Rule establishing its regulatory framework over laboratory developed tests...more

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