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Clinical Laboratories › Laboratory Developed Tests › Chevron Deference

Proskauer - Health Care Law Brief

Post‑Chevron Spotlight: Federal Court Nixes FDA Rule Reclassifying Laboratory Services as Medical Devices

Proskauer - Health Care Law Brief on

In another rebuke to federal regulatory overreach, the U.S. District Court for the Eastern District of Texas (“District Court”) has vacated the Food and Drug Administration’s (“FDA”) 2024 final rule that sought to bring...more

Paul Hastings LLP

A Sea Change Looms as FDA Finalizes Its Controversial Regulation Asserting Jurisdiction Over LDTs

Paul Hastings LLP on

On April 29, 2024, after years of false starts trying to expand oversight of laboratory developed tests (“LDTs”) through administrative and legislative actions, FDA announced the much-anticipated—and highly...more

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