ACLA Lawsuit Says FDA Lacks Authority to Regulate Lab-Developed Tests as Medical Devices
- May 31, 2024
The American Clinical Laboratory Association (ACLA) and its member company HealthTrackRx are challenging in court a recent final rule spelling out the Food and Drug Administration's (FDA's) plan to regulate laboratory-developed tests (LDTs) as medical devices under the Federal Food, Drug, and Cosmetic Act.
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