Texas Court Vacates FDA’s Laboratory Developed Test (LDT) Final Rule
By EsqSocial Corporation 03/04/25
A Texas judge for the U.S. District Court for the Eastern District of Texas issued a ruling on March 31, 2025, to vacate and set aside, in its entirety, the U.S. Food and Drug Administration’s (FDA) Final Rule titled Medical Devices; Laboratory Developed Tests (LDTs) (LDT Final Rule). The Court remanded the matter to the Secretary of the U.S. Department of Health and Human Services (HHS) “for further consideration.” The LDT Final Rule would have required companies to obtain FDA clearance in...
By: Foley & Lardner LLP