Enhancing CLIA Act of 2026

Key Points

• The bill shifts oversight of laboratory developed tests (LDTs) away from the FDA and places them under CLIA regulation by the Secretary of Health and Human Services. This means custom tests made and used inside a single lab or lab network would no longer be treated as medical devices under FDA rules.
• Starting two years after enactment, labs must prove their custom tests are analytically and clinically valid before offering them. Tests used for patient care must show they can accurately measure what they claim and reliably achieve their stated medical purpose.
• The bill creates a public database run by the Centers for Medicare and Medicaid Services where labs must register their custom tests, including what the test measures, what diseases it targets, and a summary of its performance. Labs must also report serious test errors that cause harm or death.
• Labs can voluntarily seek extra validation from approved third parties, including the FDA, but this step is optional. If a lab chooses FDA review, the FDA must follow the new CLIA-based standards rather than its traditional medical device rules.
• The government must review lab regulations at least every five years and seek public input on whether updates are needed to keep pace with new technologies like molecular diagnostics, digital pathology, and next generation sequencing.