CEO SUMMARY: Congress is gearing up for a debate on how to regulate laboratory-developed tests (LDTs) and other in vitro clinical tests (IVCTs). The VALID Act sets the stage for the FDA to take a greater role in pre-market review of LDTs, and the VITAL Act proposes to keep those tests under CLIA while calling […]
Congress May Soon Act on LDT, IVCT Regulation
Major changes in regulation of LDTs have the attention of many labs, IVD manufacturers
- By Robert Michel
- > From the Volume XXVIII, No. 16 - November 29, 2021 Issue
- Tags: aacc, acla, Advanced Medical Technology Association, american association for clinical chemistry, American Clinical Laboratory Association, AMP, association of molecular pathology, Centers for Medicare and Medicaid Services, clia, clinical laboratory improvement amendments, Congress, COVID-19, Department of Health and Human Services, Diana DeGette (D-CO), FDA, Food and Drug Administration, House of Representatives, in vitro clinical test, in vitro diagnostics, IVCT, IVD, lab intelligence, laboratory-developed test, Larry Bucshon MD (R-IN), ldt, Mark Birenbaum PhD, Medical Device User Fee Amendments, Michael Bennet (D-CO), Mike Braun (R-IN), national independent laboratory association, NILA, President Stephen Master MD PhD, Rand Paul MD (R-KY), Richard Burr (R-NC), SARS-CoV-2, Scott Whitaker, Senate, the dark report, The Yale Law Journal, Tom Sparkman, VALID, Verified Innovative Testing in American Laboratories Act of 2021, Verifying Accurate Leading-Edge IVCT Development Act of 2020, VITAL
