Enhancing CLIA Act of 2026

This bill amends the Clinical Laboratory Improvement Amendments (CLIA) to establish a new regulatory framework for laboratory developed tests (LDTs) under the Public Health Service Act, removing them from FDA device regulation. It requires LDTs to meet standards of analytical and clinical validity, creates a voluntary third-party affirmation process, and sets transition rules for existing FDA-regulated tests.

Sec. 2, Enhanced regulation of laboratory developed tests: This section amends CLIA to define key terms like analytical validity, clinical validity, and laboratory developed test. It requires that, starting 2 years after enactment, no laboratory may perform an LDT unless it meets the applicable standard (analytical and clinical validity for clinical use; analytical validity for investigational use). Laboratories must establish performance specifications for analytical validity and document evidence for clinical validity. Laboratories may obtain voluntary supplemental affirmations from approved third parties, including the FDA, that an LDT meets the standard. The Secretary must approve third parties meeting certain criteria. A process is established for third-party review within 60 days. Certain tests are deemed to have a supplemental affirmation, including those approved by the New York State Department of Health or under the MolDX Program.

Sec. 3, Transition: The amendments take effect immediately upon enactment, but regulations cannot be implemented until 2 years after enactment. The Secretary must issue proposed regulations within 180 days, establish a centralized database within 2 years, and revise the definition of in vitro diagnostic products within 30 days to exclude LDTs. For LDTs with existing FDA approvals or pending applications, laboratories may notify FDA within 60 days whether they intend to modify the test to remain a device. If not, the test is no longer a device and is deemed to have a supplemental affirmation from FDA.

Sec. 4, CLIA updates: The Secretary must issue a proposed regulation within 180 days to establish new examination types consistent with current technology, including molecular diagnostics and digital pathology. CMS must provide public notice and comment for new subregulatory guidance, hold annual open forums with laboratories, and review CLIA regulations at least every 5 years with a public request for information.