Laboratory-Developed Tests (LDTs) Do Not Qualify as ‘Devices’ Under the Food, Drug and Cosmetic Act
By EsqSocial Corporation 08/04/25
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 tests (LDT) as “devices” under the Food, Drug, and Cosmetic Act (FDCA). The court’s reasoning relied on the 2024 Supreme Court decision that overturned Chevron deference Loper Bright Enterprises v. Raimondo. In Loper Bright, the Supreme Court ruled that courts must exercise...
By: Faegre Drinker Biddle & Reath LLP