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?"