Enhancing CLIA Act of 2026

This bill would place laboratory developed tests (tests designed and run within a certified lab) under the federal clinical lab law known as CLIA, run by the Secretary of Health and Human Services, instead of under FDA medical device law. Starting two years after enactment, labs could only perform such tests if they show reasonable evidence the tests are accurate and, for clinical use, valid for their stated purpose. Labs would have to list their tests in a public federal database, report test errors linked to serious harm or death, and stop using a test if the Secretary finds it does not meet the standard. Labs could choose to get an optional review from approved third parties, including the FDA for a fee, and the bill also requires updates to CLIA rules and public notice before guidance changes.

Full text and official record on Congress.gov

Sponsors

• Neal P. Dunn Republican sponsor
• 0 cosponsors