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Proposed rule

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

Built by the Tribune's code from the Federal Register. No AI wrote this page. Published in the Federal Register July 16, 2026. Document 2026-14358. Updated Nov. 8, 2026.

What it does

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.

The Centers for Medicare & Medicaid Services's summary, as published in the Federal Register.

What it would change

1 part of Title 42 of the Code of Federal Regulations:

42 CFR 493

Before this

No earlier Federal Register document under regulation identifier 0938-AW01 since Jan. 1, 2025.

What happens next and when

To be assured consideration, comments must be received at one of the addresses provided below, by September 14, 2026.

The agency's dates, word for word.

Document number2026-14358
ActionRequest for information.
AgenciesHealth and Human Services Department; Centers for Medicare & Medicaid Services
PublishedJuly 16, 2026
Comments closeSept. 14, 2026
Regulation identifier (RIN)0938-AW01
DocketCMS-2026-2345

Source: the Federal Register (public domain). The document in the Federal Register