Congressman Neal Dunn, M.D. today 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), to further innovation... "The Enhancing CLIA Act will strengthen innovation, increase transparency, and modernize regulation of laboratory developed testing services," said Congressman Dunn.
I will update CLIA to modernize the regulation of laboratory developed tests, increase transparency, and strengthen oversight while preserving innovation and patient access.
Occurrences
Congressman Neal Dunn, M.D. today 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), to further innovation.
Congressman Neal Dunn, M.D. today 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), to further innovation.
Evidence
Congressman Neal Dunn, M.D. today 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 Enhancing CLIA Act will strengthen innovation, increase transparency, and modernize regulation of laboratory developed testing services.' The bill would direct CMS to establish a transparent and publicly accessible database, reaffirm CMS/CLIA oversight, and establish centralized error reporting and stronger oversight authority.
The 2026 news list includes the May 18, 2026 press release for the Enhancing Clinical Laboratory Innovation and Access Act (Enhancing CLIA Act) of 2026, confirming the introduction remained active on the member’s official site during the lookback window.
FDA states that CLIA of 1988 and associated regulations provide the authority for certification and oversight of clinical laboratories and laboratory testing, and that multiple federal agencies administer the CLIA program.
FDA explains that LDT oversight remains tied to FDA's regulatory approach and distinguishes CLIA certification from FDA/FD&C Act requirements for the safety and effectiveness of tests, including that CLIA inspections do not verify test compliance with FD&C Act requirements.
The current House press-release feed shows Rep. Dunn's latest 2026 item as May 22, 2026, and the CLIA/LDT introduction from May 18 remains the most recent clinical-labs item on the page; no June 20-22 follow-up, markup, floor action, or enactment appears in the feed.
FDA's LDT FAQ says FDA is phasing out general enforcement discretion for IVDs offered as LDTs and that the agency expects compliance milestones under the FDA/CMS framework; the page is marked current as of 01/15/2025.
Assessments
Dunn introduced the Enhancing CLIA Act of 2026, which directly matches the promised goals of modernizing CLIA, increasing transparency, and strengthening oversight. That is a serious legislative attempt, but the evidence provided shows only introduction and no committee passage, floor action, or enactment, so the promise was not fully delivered.
Dunn made a concrete effort that closely matches the promise by introducing the Enhancing CLIA Act of 2026, with provisions aimed at modernizing CLIA regulation of laboratory developed tests, increasing transparency, and strengthening oversight while preserving innovation and access. However, the evidence only shows bill introduction and advocacy, not committee passage, floor passage, enactment, or implemented regulatory change. The surrounding FDA/CLIA evidence indicates the underlying regulatory framework remained in place during the period. Under the rubric, a serious legislative attempt that did not achieve the promised policy outcome counts as not delivered, with effort credit.