CMS, CDC, and HHS Seek Public Input on Potential CLIA Updates

Centers for Medicare & Medicaid Services (CMS), Centers for Disease Control and Prevention (CDC), and the Department of Health and Human Services (HHS) have published a Request for Information (RFI) concerning potential updates to the Clinical Laboratory Improvement Amendments (CLIA) of 1988 regulations.

The agencies explained that laboratory medicine has advanced significantly since the current framework was adopted. The RFI seeks information from laboratories regarding breath testing, laboratory processes and procedures, emergency preparedness, biosafety, biosecurity, and cybersecurity, and specialty testing. Responses to the request may help CMS determine what, if any, updates should be made to the current CLIA regulations. To be assured consideration, comments must be received by September 14, 2026.

Federal Register :: Request for Information; Clinical Laboratory Improvement Amendments of 1988 (CLIA) Regulations

- Sarah Stewart, Vice President, RCS