Clinical laboratory testing technology has advanced significantly since the Clinical Laboratory Improvement Amendments of 1988 (CLIA) regulations were implemented in 1992. This request for information (RFI) seeks input from the public regarding various topics related to the CLIA regulations, including: breath testing; laboratory processes and procedures; emergency preparedness, biosafety and biosecurity, and cybersecurity; and specialty testing areas. Responses to this RFI may be used to help inform CMS and the CDC as to what types of action, if any, should be taken to update the existing CLIA regulations through future notice and comment rulemaking.
US Federal Register - CMS Rules · July 16, 2026
Request for Information on Clinical Laboratory Improvement Amendments (CLIA) Regulations
Original title: Request for Information; Clinical Laboratory Improvement Amendments of 1988 (CLIA) Regulations
CMS and CDC seek public input on updating CLIA regulations covering laboratory processes, cybersecurity, biosafety and emergency preparedness.
Published by US Federal Register - CMS Rules. HealthSignal links to the original document; the summary above is extracted from the source text.