How an Emergency Use Authorization (EUA) Works

An EUA may be issued by the FDA to allow access to critical medical products that may help during a public health emergency. An EUA is different from approval/licensure.

The following criteria must be met for an EUA to be issued:

  • The product will be used for a serious or life-threatening disease or condition.
  • Based on the totality of scientific evidence available, it is reasonable to believe the product may be effective.
  • The known and potential benefits of the product outweigh the known and potential risks of the product.
  • There is no adequate FDA-approved alternative available.

FDA Information on EUAs

FDA Guidance on EUA for Vaccines to Prevent COVID-19

FDA Video, "What is an EUA?"



Page last reviewed: November 19, 2020
Content source: November 19, 2020