CEO SUMMARY: In a major win for clinical laboratories, a federal judge vacated the FDA’s final rule on LDTs, writing in his decision that the agency overstepped its authority. For now, labs can develop and modify LDTs without FDA oversight, but future action in some form is likely. In part one of our report about […]
With LDT Rule Vacated, Labs Await FDA Retort
Judge decries idea of LDTs as medical devices, but FDA could step in elsewhere, experts say
- By Robert Michel
- > From the Volume XXXII, No. 6 - April 21, 2025 Issue
- Tags: 501(k), acla, AI, American Clinical Laboratory Association, AMP, artificial intelligence, association for molecular pathology, clia, Companion diagnostics, Congress, COVID-19 test, Department of Health and Human Services, Department of Justice, diagnostic reagents, digital diagnostics, DOJ, FDA, FDCA, Food and Drug Administration, Food Drug and Cosmetic Act, Gail Javitt, Healthcare Practice Group, HHS, Hyman Phelps and McNamara, Jane Pine Wood JD, Judge Sean Jordan, lab intelligence, laboratory-developed test, Lale White, ldt, LDT regulation, LDT rule, McDonald Hopkins, medical devices, premarket approval, the dark report, Trump administration, US District Court for the Eastern District of Texas, VALID Act, Verifying Accurate Leading-edge IVCT Development Act, xifin
