On May 19, 2026, Representative Neal Dunn, a medical doctor, introduced the Enhancing Clinical Laboratory Innovation and Access Act (Enhancing CLIA Act) of 2026 to update the regulation of diagnostic testing services under the Clinical Laboratory Improvement Amendments (CLIA). The bill (H.R. 8890) is a follow-up legislative effort to address laboratory-developed test (LDT) oversight after the 2025 court decision in ACLA v. FDA that vacated the FDA's final rule regulating LDTs as medical devices, reaffirming CLIA as the primary regulatory authority.

Per Rep. Dunn’s press release: “By updating CLIA to reflect modern laboratory science and codifying clear lines of regulatory authority, the Enhancing CLIA Act provides regulatory certainty, strengthens accountability, and ensures continued innovation in diagnostic testing. As a physician, I know firsthand that timely and accurate diagnostic testing is essential to patient care. The Enhancing CLIA Act will strengthen innovation, increase transparency, and modernize regulation of laboratory developed testing services. This legislation restores confidence in testing services while avoiding duplicative and burdensome requirements that limit patient access and slow scientific progress. We can ensure necessary oversight of the CLIA program without undermining the laboratories that deliver cutting-edge diagnostics to patients across the country.” 

Key provisions

• Laboratory operations shall be regulated by the Secretary under Health and Human Services and not under the Federal Food, Drug, and Cosmetic Act.
• The Food, Drug, and Cosmetic Act is amended so that the term "device" does not include laboratory developed tests.
• Establishes statutory requirements for performing LDTs that are self-determined by the lab for both:

o   Analytical validity (whether the test accurately measures what it claims to measure)

o   Clinical validity (whether the result is meaningfully associated with a clinical condition or outcome)

• In addition to the self-determined standard is an optional confirmation that a CMS-approved third party agrees the test meets the standard. Approved third parties must apply standards CMS judges "sufficiently risk-based, rigorous, and not overly burdensome," and must agree to notify CMS of adverse findings (false/deceptive claims, or a probable risk of serious adverse health consequences). The FDA is one of the approved third parties. Regulations are further amended so accrediting bodies cannot require the third-party confirmation.
• Two years after enactment, every lab must register each LDT in a CMS-centralized database, which will have a public-facing interface on the CMS website and a secure submission portal.
• Two years after enactment, a lab must file a report within five calendar days of becoming aware of an undetected inaccurate result for an LDT that reasonably suggests the test caused serious harm resulting in death or an imminent threat to public health. Less serious-harm events are captured in quarterly reports. 

ASCP has indicated that it will initiate a formal review of the legislation and will be working with the laboratory community on this proposed regulation.

I welcome your comments and questions — please send them to me at [email protected].