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.