To amend the Public Health Services Act, commonly referred to as the "Clinical Laboratory Improvement Amendments" or "CLIA", with respect to laboratory developed tests, and for other purposes.
About This Bill
Committee
Latest Action · May 19, 2026
Referred to the Committee on Energy and Commerce, and in addition to the Committee on Ways and Means, for a period to be subsequently determined by the Speaker, in each case for consideration of such provisions as fall within the jurisdiction of the committee concerned.
H.R. 8890, the Enhancing Clinical Laboratory Innovation and Access Act of 2026, reforms how laboratory-developed tests (LDTs) are regulated under the Clinical Laboratory Improvement Amendments by placing them under the Department of Health and Human Services rather than FDA oversight. The bill requires laboratories to demonstrate that their tests are analytically and clinically valid, either through internal evidence or third-party validation approved by the FDA, with compliance required within two years of enactment. Laboratories must register all tests in a centralized FDA database, submit detailed performance data, report serious errors within five days, and can only perform these tests within their own high-complexity laboratory or corporate organization with limited exceptions. The legislation also modernizes CLIA regulations by requiring the Secretary to establish new examination standards for molecular diagnostics within 180 days and mandates that the Centers for Medicare and Medicaid Services provide 90 days' advance notice of regulatory changes and conduct comprehensive reviews every five years. These changes affect all clinical laboratories offering developed tests and aim to balance innovation in diagnostic testing with appropriate safety and quality oversight.
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