Laboratory Developed Tests (LDTs) are critical for diagnosing rare diseases and addressing unmet clinical needs. They are developed, manufactured, and used within a single licensed clinical laboratory for purposes of clinical...more
5/30/2025
/ Asia Pacific ,
Australia ,
Centers for Medicare & Medicaid Services (CMS) ,
China ,
CLIA ,
Food and Drug Administration (FDA) ,
Government Agencies ,
Laboratory Developed Tests ,
Medical Devices ,
Regulatory Reform ,
Singapore
On March 31, 2025, Judge Sean D. Jordan of the U.S. District Court for the Eastern District of Texas issued an opinion and judgment in American Clinical Laboratory Association v. FDA (“ACLA v. FDA”), a closely watched case...more