CEO SUMMARY: With the release of a public statement about the oversight of LDTs on Jan. 24, 2024, officials at both the Food and Drug Adminstration and the Centers for Medicare and Medicaid Service went on record that both agencies are aligned in the specific roles each agency should have in the review and oversight […]
FDA & CMS Issue Letter, Agree on LDT Oversight
It is a public statement that the two agencies are in agreement regarding FDA oversight of LDTs
- By Robert Michel
- > From the Volume XXXI, No. 2 - February 5, 2024 Issue
- Tags: and Cosmetic Act, CDRH, Center for Clinical Standards and Quality, Center for Devices and Radiological Health, Centers for Medicare and Medicaid Services, clia, Clinical Laboratory Improvement Amendments of 1988, CMS, COVID-19, Department of Health and Human Services, Dora Hughes MD MPH, Drug, FDA, FDCA, Food, Food and Drug Administration, HHS, IVD, ivd/lab informatics, Jeff Shuren MD PhD, laboratory developed testing procedure, laboratory-developed test, LDP, ldt, VALID Act, Verified Innovative Testing in American Laboratories Act, Verifying Accurate Leading-edge IVCT Development Act, VITAL Act
