CMS and CDC reopen the CLIA regulations with a request for information — comments close September 14

CMS and CDC published a Request for Information on the Clinical Laboratory Improvement Amendments of 1988 (CLIA) regulations in the Federal Register on July 16, 2026 (CMS-3485-NC, docket CMS-2026-2345). In the document's own words, it '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.'

Comments close September 14, 2026. BE PRECISE ABOUT WHY THIS IS HERE: the RFI does not mention FQHCs, RHCs, community health centers, certificates of waiver, or physician office laboratories anywhere in its text — that was checked term by term.

The health-center relevance is structural, not asserted by the document: essentially every health center holds a CLIA certificate (most commonly a Certificate of Waiver or PPM) for in-clinic testing, so any rulemaking that follows would reach them the way it reaches every other CLIA-certified site. This is the first substantive regulatory reopening of CLIA since the 1992 implementing rules, which makes the comment window unusually consequential for small-volume testing sites that rarely get represented in lab policy.

Do not read any FQHC-specific certification or billing change into this document — there is none yet, only a question-asking stage.