Data / Federal rules / 2026-14358

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

The Centers for Medicare & Medicaid Services published this proposed rule in the Federal Register on July 16, 2026. Comments closed on September 14, 2026.

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What the agency says

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.

Key facts

Document number: 2026-14358
Type: Proposed rule
Action: Request for information
Agency: Health and Human Services Department; Centers for Medicare & Medicaid Services
Published: July 16, 2026
Comments due: September 14, 2026
Dates: To be assured consideration, comments must be received at one of the addresses provided below, by September 14, 2026.
Docket: CMS-3485-NC
Regulation ID (RIN): 0938-AW01
Code of Federal Regulations: 42 CFR 493
Pages: 6

The document on federalregister.gov PDF

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Everything from the Centers for Medicare & Medicaid Services · Published in July 2026

Read from the Federal Register API, last updated 2026-10-23. The document on federalregister.gov is the official record; dates and dockets can change through later corrections. Free to reuse with credit to SpecStream under CC BY 4.0.