What does Preamble of Enhancing CLIA Act of 2026 do?

This bill proposes to amend the Public Health Services Act, also known as the Clinical Laboratory Improvement Amendments (CLIA). The bill's focus is on laboratory developed tests. The bill has other purposes, though these are not specified in this section.

What does SHORT TITLE. of Enhancing CLIA Act of 2026 do?

This bill is formally titled the Enhancing Clinical Laboratory Innovation and Access Act of 2026.

What does ENHANCED REGULATION OF LABORATORY DEVELOPED TESTS. of Enhancing CLIA Act of 2026 do?

This section amends the Public Health Services Act, specifically Section 353, concerning the regulation of laboratory developed tests (LDTs). It defines key terms related to LDTs, including 'analytical validity,' 'clinical validity,' 'clinical use,' and 'investigational use.' The text establishes an 'applicable standard' for LDTs, requiring reasonable assurance of analytical and clinical validity for clinical use and reasonable assurance of analytical validity for investigational use. Beginning two years after enactment of the Enhancing CLIA Act of 2026, laboratories may not perform LDTs unless they meet the applicable standard. Laboratories can obtain supplemental affirmations from approved third parties to demonstrate that an LDT meets the applicable standard. The Food and Drug Administration may provide supplemental affirmations that a laboratory developed test meets the applicable standard. The Federal Food, Drug, and Cosmetic Act is also amended to clarify the application of certain provisions to LDTs and devices used with them. National coverage determinations for clinical laboratory diagnostic tests will consider supplemental affirmations from approved third parties as equivalent to approval or clearance under the Federal Food, Drug, and Cosmetic Act.

What does TRANSITION. of Enhancing CLIA Act of 2026 do?

This section outlines transition procedures following the Act's enactment. The Secretary of Health and Human Services must promulgate regulations within 180 days and establish a centralized database within two years. Final regulations to mitigate conflict of interest for oversight organizations must be promulgated within two years. The definition of 'in vitro diagnostic products' is revised to exclude laboratory developed tests and include protocols for disease diagnosis. Regulations issued under this Act will not be implemented for two years after enactment, except as otherwise specified. Laboratory developed tests with existing premarket approvals, exemptions, clearances, authorizations, or licensure applications are treated as devices under the Federal Food, Drug, and Cosmetic Act until certain notifications are submitted. Laboratories can notify the Food and Drug Administration within 60 days of enactment whether they intend to modify their tests to meet the definition of a device. Upon transitioning away from device status, laboratory developed tests are deemed to have a supplemental affirmation from the Food and Drug Administration.

What does CLINICAL LABORATORY IMPROVEMENT AMENDMENTS (CLIA) UPDATES. of Enhancing CLIA Act of 2026 do?

This section requires the Secretary to propose regulations establishing new types of examinations for laboratories under section 353 of the Public Health Service Act, considering advancements in areas like molecular diagnostics. Within one year of finalizing these regulations, the Secretary must evaluate whether additional proficiency testing programs are needed for these new specialties. The Centers for Medicare and Medicaid Services (CMS) must provide a public report and opportunity for comment at least 90 days before issuing new or revised subregulatory guidance related to laboratory regulation. CMS must hold regular open door forums with clinical laboratories, at least annually, to discuss regulatory issues. CMS must review regulations under section 353 at least once every 5 years, issue a request for information regarding necessary updates, and establish a public docket for comments for at least 180 days.

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Enhancing CLIA Act of 2026

Last updated: 5/19/2026 · Introduced: 5/19/2026

Author: Neal Dunn (R-FL)

TL;DR (AI)

This bill establishes a regulatory framework for laboratory developed tests (LDTs), requiring laboratories to demonstrate reasonable assurance of analytical and clinical validity for clinical use and analytical validity for investigational use, beginning two years after enactment.
The bill revises definitions related to in vitro diagnostic products and allows for third-party or FDA supplemental affirmations to demonstrate LDT compliance, which will be considered equivalent to FDA approval for national coverage determinations.
The bill mandates periodic reviews and updates to clinical laboratory regulations, including requirements for the Secretary of Health and Human Services to propose new examination types and for CMS to provide public reports and forums for laboratory feedback.

119th Congressin committeeOfficial page

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Includes provisions on preamble, short title., and 3 more.

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