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U.S. Department of Health and Human Services

Emergency Use Authorization

FDA may issue an EUA for an unapproved drug, biological product, or device following a Declaration by the Secretary of Health and Human Services that the circumstances justify such authorization based on one of the following:

  • A determination by the Secretary of Homeland Security that there is an actual or significant potential for a domestic emergency involving a heightened risk of attack with a biological, chemical, radiological, or nuclear agent(s);
  •  A determination by the Secretary of Homeland Security of a material threat of a chemical, biological, radiological or nuclear agent sufficient to affect national security or the health and security of United States citizens living abroad.
  • A determination by the Secretary of Defense that there is an actual or significant potential for a military emergency involving a heightened risk to United States military forces of attack with a biological, chemical, radiological, or nuclear agent(s); or
  • A determination by the Health and Human Services Secretary that there is a public health emergency or a significant potential for a public health emergency that affects, or has significant potential to affect, national security or the health and security of U.S. citizens living abroad and involves a biological, chemical, radiological, or nuclear agent(s) or disease or condition that may be attributable to such agent(s).

FDA may then issue an EUA for a product if FDA finds that:

  • the agent specified in the declaration of emergency can cause a serious or life-threatening disease or condition;
  • based on the totality of scientific evidence available, it is reasonable to believe that the product may be effective in diagnosing, treating, or preventing the serious or life-threatening disease or condition, or a serious or life-threatening disease or condition caused by a product authorized approved, cleared, or licensed by FDA for diagnosing, treating, or preventing the disease or condition;
  • the known and potential benefits of the product outweigh the known and potential risks of the product when used to diagnose, prevent, or treat the serious or life-threatening disease or condition; and
  • there is no adequate, approved, and available alternative to the product for diagnosing, preventing, or treating such serious or life-threatening disease or condition.
FDA will, in issuing the EUA, impose conditions on the emergency use that is authorized.  For more information on the emergency use authority, please see  Emergency Preparedness and Response:  Emergency Use Authorization


  • This page last reviewed: April 24, 2013