Enhancing CLIA Act of 2026 amends the Public Health Service Act to regulate laboratory developed tests.
The Enhancing CLIA Act of 2026 amends the Public Health Service Act to enhance regulation of laboratory developed tests. It mandates that laboratories must ensure their tests meet analytical and clinical validity standards. Laboratories must submit detailed information about their tests to the Secretary of Health and Human Services, including performance specifications and clinical use details. The Secretary can request additional information if concerns arise. Laboratories can seek supplemental affirmation from approved third parties that their tests meet the applicable standard.
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- Overview
- Core Provisions
- Implementation
- Impact
- Legal Framework
- Critical Issues
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