CEO SUMMARY: On July 5, the final laboratory developed test (LDT) rule issued by the federal Food and Drug Administration (FDA) takes effect. In response, the American Clinical Laboratory Association (ACLA) filed a lawsuit in federal court in Texas to challenge the FDA’s actions. In this exclusive interview, ACLA President Susan Van Meter provides insight […]
ACLA President Van Meter Discusses LDT Lawsuit
Did FDA exceed its statutory authority by issuing its LDT rule? A federal court will now hear this case
- By Robert Michel
- > From the Volume XXXI, No. 8 - June 10, 2024 Issue
- Tags: acla, American Clinical Laboratory Association, arup laboratories, Department of Health and Human Services, FDA, FDCA, Food and Drug Administration, Food Drug and Cosmetic Act, HealthTrackRx, HHS, in vitro diagnostics, IVD, Jay Reddy PhD, LabCorp, laboratory-developed test, ldt, Mayo Clinic, MDR, medical device reporting, people, Quest Diagnostics, Rep. Anna Eshoo, Susan Van Meter, U.S. District Court in the Eastern District of Texas, U.S. House Energy and Commerce Subcommittee on Health
