The Centers for Medicare & Medicaid Services (CMS) has revised the Clinical Laboratory Improvement Amendments of 1988 (CLIA) Post-Public Health Emergency (PHE) Guidance as of October 14, 2026.

The most important thing to know is the emergency use authorization (EUA) declarations for COVID-19 in vitro diagnostic tests (IVDs) will be terminated on December 26, 2026, due to reduced demand and a significant number of COVID-19 tests receiving marketing authorization.

However, the U.S. Food and Drug Administration (FDA) will allow the distribution and/or continued use of IVDs if the manufacturer receives marketing authorization acceptance before December 26, but the FDA has not taken final action.

Furthermore, the FDA does not intend to request market removal for single-use, nonlife-supporting/non-life-sustaining devices distributed before December 26. This includes IVDs, according to the guidance.

Additionally, “In alignment with FDA’s enforcement discretion, CMS will allow laboratories to use these tests under the same circumstances in a manner consistent with the EUA in effect prior to the termination date of the EUA declarations, including the authorized settings (high, moderate, or waived), until the product expiration date.”

Additional key points:

• Laboratories are no longer required by CLIA to report SARS-CoV-2 test results, as the PHE is ended.
• As of March 23, 2026, remote cytology slide viewing is no longer permitted unless the location obtains a CLIA certificate.
• As of March 30, 2026, the temporary exercise of enforcement discretion related to the i-STAT cTnI test cartridge for moderate complexity tests has ceased, according to CMS.