CEO SUMMARY: Even though a federal court vacated the FDA’s final rule for laboratory developed tests, experts warn that the agency may still be able to regulate some LDTs via its authority over diagnostic software. An attorney notes that software’s central role in modern lab tests could allow FDA oversight. Long-term regulatory clarity is needed […]
FDA Has Future Avenues to LDT Oversight
The agency’s authority to regulate software as a medical device is one such opening, attorney says
- By Scott Wallask
- > From the Volume XXXII, No. 15 - October 27, 2025 Issue
- Tags: 21st Century Cures Act, Christine Bump, clia-certified laboratory, Cybersecurity, FDA, FDCA, Food and Drug Administration, Food and Drug Omnibus Reform Act, Food Drug and Cosmetic Act, ivd/lab informatics, laboratory-developed test, ldt, medical device, molecular diagnostics, next generation sequencing, Penn Avenue Law and Policy, Today’s Clinical Lab
