CMS Seeks Broad Stakeholder Input on CLIA Regulations, Signaling Potential Modernization of Current Lab Regulatory Scheme

Short summary

CMS and CDC issued a request for information seeking public input on modernizing CLIA lab regulations that have been largely unchanged since 1992. The RFI covers breath testing, lab processes, emergency preparedness, and specialty testing, with notable subcategories including AI use in result interpretation and validation standards for laboratory-developed tests. Comments are due by September 14, 2026.

• •CMS/CDC seeking stakeholder input to modernize 1992-era CLIA lab regulations
• •RFI covers AI in result interpretation, LDT validation, and data-only facility regulation
• •Comment deadline is September 14, 2026

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