CEO SUMMARY: Publication of the Food and Drug Administration’s final rule on laboratory developed tests (LDTs) is already causing some labs to consider withdrawing their existing LDTs because of compliance costs. Two experienced lab industry attorneys discuss aspects of the LDT rule and what they hear from their clinical laboratory clients. THROUGHOUT THE CLINICAL LABORATORY […]
Attorneys Assess Impact of FDA’s Final LDT Rule
Some lab clients already signaling concerns that compliance costs will end their LDT offerings
- By Robert Michel
- > From the Volume XXXI, No. 8 - June 10, 2024 Issue
- Tags: acla, American Clinical Laboratory Association, Bass, Berry and Sims PLC, Danielle Sloane JD, Department of Health and Human Services, FDA, FDCA, Food and Drug Administration, Food Drug and Cosmetic Act, HHS, IDE, Investigational Device Exemption, Jane Pine Wood JD, laboratory-developed test, ldt, New York State Clinical Laboratory Evaluation Program, NYS CLEP
