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CLIA Regulations and Federal Register Documents

Guidance for Clinical Laboratory Improvement Amendments (CLIA) regulations.

Refer to the Related Links Outside CMS section below for the following information concerning the Clinical Laboratory Improvement Amendments (CLIA) regulations:

  • The most current version of the CLIA regulations Part 493, including all changes through 5/12/14. This information is on the Centers for Disease Control and Prevention (CDC) website;
  • A chronological list containing on-line copies of the CLIA regulations and related Federal Register publications (CDC Site); 
  • The Code of Federal Regulations search feature at the Government Printing Office (GPO) Access Site; and 
  • The Federal Register search feature at the GPO Access Site.

Note: For help in searching Regulations or the Federal Register on the GPO Access Site, call 1-202-512-1800 or 1-866-512-1800.

Issued by: Centers for Medicare & Medicaid Services (CMS)

Issue Date: December 09, 2019

HHS is committed to making its websites and documents accessible to the widest possible audience, including individuals with disabilities. We are in the process of retroactively making some documents accessible. If you need assistance accessing an accessible version of this document, please reach out to the guidance@hhs.gov.

DISCLAIMER: The contents of this database lack the force and effect of law, except as authorized by law (including Medicare Advantage Rate Announcements and Advance Notices) or as specifically incorporated into a contract. The Department may not cite, use, or rely on any guidance that is not posted on the guidance repository, except to establish historical facts.