New Bill Introduced in Congress Seeks to Address LDT Regulation

Rep. Neal Dunn, M.D. (R-Fla.-2) introduced the Enhancing Clinical Laboratory Innovation and Access (Enhancing CLIA) Act (H.R. 8890) on May 19 to update the regulation of laboratory-developed tests (LDTs) under CLIA.

This bill affirms the outcome of a 2025 District Court case that ruled the U.S. Food and Drug Administration lacked the authority to regulate LDTs as devices under the Federal Food, Drug, and Cosmetic Act. In a press release, the American Clinical Laboratory Association wrote in support of the bill: “CLIA has long provided a strong foundation for laboratory oversight, and the legislation recognizes the important role that LDTs serve in delivering timely, personalized, and actionable health information for patients and providers.”

Besides affirming that LDTs are professional services (not devices) regulated by the Centers for Medicare & Medicaid Services (CMS) under CLIA, the bill would require CMS to establish a public database with information about LDTs, including performance specifications and validation information. Additionally, it would utilize existing review and oversight mechanisms to enable laboratories to voluntarily obtain confirmation of an LDT’s validity from recognized third parties. Finally, it would establish centralized error reporting processes, improving CMS oversight authority.

The bill has been referred to the House Committees on Energy & Commerce and Ways & Means for further consideration.

Sources:

https://dunn.house.gov/news/documentsingle.aspx?DocumentID=527

https://www.acla.com/acla-statement-on-introduction-of-the-enhancing-clinical-laboratory-innovation-and-access-act-enhancing-clia-act-of-2026/

https://www.congress.gov/bill/119th-congress/house-bill/8890?hl=CLIA&s=4&r=1