Request for Information; Clinical Laboratory Improvement Amendments of 1988 (CLIA) Regulations
Published by Health and Human Services Department on 2026-07-16
The consultation is still open. Comments close on 2026-09-14, in 5 days. This is the only point at which the text can still change.
- Issued by
- Health and Human Services Department
- Jurisdiction
- US
- Takes effect
- Not stated
- Comments close
- 2026-09-14
In the issuer’s words
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.