FDA's LDT Rule Struck Down by Court: FDA Has Lost the Battle, But Is the War Over?
By EsqSocial Corporation 07/04/25
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 Association (ACLA) v. FDA and Association for Molecular Pathology v. FDA, the United States District Court for the Eastern District of Texas vacated FDA’s final rule seeking to regulate laboratory developed tests as medical devices. The court held that FDA’s attempt to regulate...
By: King & Spalding