10/14/2026 Laboratory Advisory: COVID Emergency Declaration Ended and Impact to Emergency Use Authorized (EUA) Tests

LOCS message

On June 30, 2026, the U.S. Department of Health and Human Services (HHS) announced that the Secretary has determined that circumstances justifying the use of COVID-19 Emergency Use Authorization (EUA) declarations no longer exist. As a result, the declaration supporting EUAs for COVID-19 in vitro diagnostics tests will terminate following a 180-day transition period, ending on December 26, 2026.

FDA has issued a guidance document for manufacturers: Transition Plan for Medical Devices Issued Emergency Use Authorizations (EUAs) Related to Coronavirus Disease 2019 (COVID-19) | FDA. The guidance document discusses the transition, including FDA's intention not to object to continued distribution while a marketing submission is under review, in certain circumstances, where an appropriate FDA marketing submission (e.g., 510(k) notification), is submitted to, and accepted by, FDA by December 26, 2026. 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.

Please review the COVID-19 tests currently used in your laboratory to determine whether any are authorized under EUA. If so, contact the manufacturer(s) to confirm whether they have or intend to pursue FDA 510(k) clearance and their expected timeline. If a test manufacturer does not intend to pursue FDA clearance, laboratories should begin planning to transition to an FDA-cleared or otherwise appropriately regulated diagnostic assay for the detection of COVID-19.

Resources

• In Vitro Diagnostics EUAs | FDA – This page links to the tables of COVID-19 IVD EUA authorizations.
• COVID-19 Tests Granted Traditional Marketing Authorization by the FDA | FDA – This page lists COVID-19 IVDs that have received traditional marketing authorization.
• Coronavirus Disease 2019 (COVID-19) | Covid | CDC
• CMS Revised Memo for COVID Testing

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Centers for Disease Control and Prevention (CDC)
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