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Medical Devices › Federal Food Drug and Cosmetic Act (FFDCA) › Statutory Interpretation

Hogan Lovells

FDA to rescind laboratory developed test rule

Hogan Lovells on

FDA decided to rescind the LDT rule after declining to appeal a district court decision vacating it. The rule reflected FDA’s latest attempt to regulate LDTs under the same framework as IVDs, which FDA considers medical...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

ArentFox Schiff

FDA’s Attempt to Regulate Lab-Developed Tests Struck Down in Federal Court

ArentFox Schiff on

On March 31, a judge in the Eastern District of Texas vacated the US Food and Drug Administration’s (FDA) rule that sought to regulate laboratory-developed tests (LDTs) as medical devices under the Federal Food, Drug, and...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

Butler Snow LLP

Express Preemption of Consumer Protection Actions: Preventing a Patchwork of State Drug and Device Regulations

Butler Snow LLP on

The Supremacy Clause of the United States Constitution declares federal law to be the “supreme Law of the Land.” Thus, when federal law and state law conflict, the state law is “preempted,” or rendered without effect. Under...more

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