CEO SUMMARY: After a federal court struck down the FDA’s final rule on laboratory developed tests, attention has shifted to Congress and CLIA as likely paths forward for oversight. A lack of bipartisan momentum makes new legislation unlikely in the near term. Experts suggest CLIA reform is the more feasible option, taking advantage of existing […]
LDT Oversight May Fall to Congress, CLIA
Clinical laboratories again have a chance to steer the debate on lab developed tests
- By Robert Michel
- > From the Volume XXXII, No. 7 - May 12, 2025 Issue
- Tags: cap, CDC, Centers for Disease Control and Prevention, Centers for Medicare and Medicaid Services, clia, CLIAC, Clinical Laboratory, Clinical Laboratory Improvement Advisory Committee, Clinical Laboratory Improvement Amendments of 1988, CMS, College of American Pathologists, Congress, COVID-19, CSD Associates, Department of Health and Human Services, diagnostic assay, diagnostics, Donald Trump, Erin Morton, EUA, executive war college, FDA, Food and Drug Administration, Goldbug Strategies, Healthcare Practice Group, HHS, IVCT Development Act, Jane Pine Wood JD, Judge Sean Jordan, lab risk & compliance, laboratory-developed test, Lale White, ldt, Martin Makary, McDonald Hopkins, Mehmet Oz, New York State Clinical Laboratory Evaluation Program, pathology management, Pew, Pew Charitable Trusts, Republicans, SARS-CoV-2 pandemic, Sheila Walcoff JD, The Joint Commission, The Washington Post, VALID Act
