Rep. Neal Dunn's Enhancing CLIA Act — a bill to update the 38 year old Clinical Laboratory Improvement Amendments that govern hospital and reference labs — is Congress's first attempt to regulate the in house diagnostics used in cancer and prenatal care since a 2025 court ruling…
A Florida physician-turned-congressman introduced legislation on May 19 that would set the first federal ground rules for laboratory-developed medical tests since a federal court stripped the FDA of authority over them last year, leaving the door to a parallel regulator open for two more years.
The bill, sponsored by Rep. Neal Dunn, a Republican and surgeon, is called the Enhancing Clinical Laboratory Innovation and Access Act of 2026. It is the first legislative response to a March 2025 ruling by the U.S. District Court for the Northern District of Texas that vacated an FDA final rule classifying laboratory-developed tests, or LDTs, as medical devices. The decision returned day-to-day oversight of those tests to the Centers for Medicare and Medicaid Services, which administers the Clinical Laboratory Improvement Amendments of 1988, the framework known as CLIA.
Laboratory-developed tests are diagnostics that a single clinical laboratory designs, validates, and performs in-house rather than buying as a kit from a manufacturer. They cover a wide swath of modern medicine: cancer liquid biopsies that look for tumor DNA in blood, non-invasive prenatal screening, genetic panels for rare disease, and the workhorses of hospital chemistry labs. Because each test is built and used in one place, regulators have long wrestled with how much to police the recipe.
The Dunn bill, in its main provisions, would reaffirm that LDTs are professional medical services overseen by CMS under CLIA rather than devices overseen by the FDA. It would direct CMS to build a public, searchable database listing each LDT with a summary of its analytical and clinical performance, and it would require labs to report to the agency any test errors that cause serious patient harm. Laboratories could also seek optional third-party review of their validation data, but they would not be required to do so. New compliance requirements would not take effect until two years after enactment. A separate provision would let a lab voluntarily keep an existing FDA clearance or approval for a test that was on the device track before the 2025 ruling.
The two-year window is the policy choice that most clearly sets the terms of the debate. Liquid-biopsy makers, NIPT providers, and academic medical centers that have been scaling up in-house sequencing panels will keep operating under existing CLIA rules until at least 2028, and any new entrant into the field can do the same. Critics of the FDA's vacated rule, including the lab industry, had argued that device-style review was duplicative and slow. Patient-safety advocates and some pathologists had argued that LDTs have grown into a market used in real clinical decisions without the pre-market evidence FDA typically requires of a diagnostic device, and that a two-year delay plus voluntary third-party review is a thinner floor than the rule that was struck down.
The most visible trade groups in the field have welcomed the bill. The American Clinical Laboratory Association, whose members include large reference labs and academic pathology centers, endorsed the legislation as consistent with its prior policy recommendations. "This bill takes a thoughtful approach to modernizing the existing CLIA framework," said ACLA president Susan Van Meter in a May 19 statement. ARUP Laboratories, a nonprofit reference lab affiliated with the University of Utah, said its chief medical officer and senior director of governmental affairs, Jonathan Genzen, considered the bill "an intriguing step forward" and "a thoughtful proposal" in a June 16 statement. ARUP and ACLA were litigants and declarants in the 2025 case that ended the FDA's device rule, a March 31, 2025 ARUP statement shows.
That shared legal posture shapes the public framing of the bill. No independent patient-safety group, academic pathologist, or FDA voice has been quoted on the record in the materials circulated since introduction; the available record is dominated by the labs that pushed the court to vacate the FDA's rule and now endorse the alternative. The bill's prospects depend in part on whether a counterweight emerges in committee, and on whether the parallel RESULTS Act, a separate ACLA-backed push to reform Medicare lab payment rates under PAMA that has drawn bipartisan interest since January, will travel with this regulatory track or compete for the same floor time.
What to watch next is concrete. House Energy and Commerce will need to decide whether to fold CLIA modernization into a broader diagnostics package or move it as a stand-alone bill, and the committee will have to decide whether the two-year implementation delay is a bridge to consensus or a feature that patient-safety advocates and the FDA's allies will try to cut. The first hearing, if one is scheduled, will be the cleanest test of whether a non-lab voice is willing to defend, or attack, the bill in public.