CMS seeks public input for updating CLIA regulations to reflect modern laboratory advances

The Centers for Medicare & Medicaid Services (CMS) is requesting public feedback to update the CLIA regulations, focusing on laboratory processes, emergency preparedness, biosafety, cybersecurity, and specialty testing areas, with a deadline of September 14, 2026.

The Centers for Medicare & Medicaid Services (CMS) is seeking feedback from the public to help with the upcoming update of the Clinical Laboratory Improvement Amendments of 1988 (CLIA) regulations. Their request for information (RFI) is published in the Federal Register.

Specifically, CMS wants insights on:

  • Breath testing
  • Laboratory processes and procedures
  • Emergency preparedness
  • Biosafety and biosecurity
  • Cybersecurity
  • Specialty testing areas

If CLIA regulations are updated, they will reflect the advancements that clinical laboratory testing technologies have undergone since the regulations were first introduced. Those who would like to submit comments to the CMS must do so electronically or by mail before September 14, 2026.

About the Author

Erin Brady

Managing Editor

Erin Brady is Managing Editor of Medical Laboratory Observer.

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