WAS IT AN EXPECTED FLOOD OF APPLICATIONS TO REVIEW laboratory developed tests (LDTs) that motivated the federal Food and Drug Administration’s (FDA’s) Center for Devices and Radiological Health (CDRH) to declare its intention “to initiate the reclassification process for most IVDs that are currently class III (high risk) into class II (moderate risk)” in a […]
FDA Issues Memo to Reclassify Many High Risk IVD Assays
Some experts claim FDA would exceed its authority and that legal challenges will ensue
- By Robert Michel
- > From the Volume XXXI, No. 5 - April 8, 2024 Issue
- Tags: 510(k) pathway, Allyson B. Mullen JD, CDRH, Center for Devices and Radiological Health, Centers for Medicare and Medicaid Services, class II, class III, Cleveland Clinic, clia, clinical laboratory improvement amendments, CMS, Congress, Congressional Review Act, COVID-19, CRA, De Novo Pathway, FDA, FDA Law Blog, Food and Drug Administration, Friends of Cancer Research, Gail H. Javitt JD, Hepatitis B, Hepatitis C, high risk, human parvovirus, Hyman Phelps and McNamara PC, in vitro diagnostics, IVD, ivd/lab informatics, Jeff Shuren MD JD, Jeffrey N. Gibbs JD, LabCorp, laboratory-developed test, ldt, LinkedIn, market clearance, moderate risk, Mycobacterium tuberculosis, OmniSeq, Predicate Device, premarket submission, Quest, Roger Klein MD JD, Scott Gottlieb MD, Steven J Gonzalez JD, U.S. Office of Management and Budget, VALID Act, Verifying Accurate Leading-edge IVCT Development Act
