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What is the difference between an Emergency Use Authorization and an FDA approval?



Last modified Feb. 17, 2021

The Emergency Use Authorization (EUA) is a different standard than FDA Approval.

FDA Approval from the US Food and Drug Agency is an independent, scientifically reviewed approval for medical products, drugs and vaccines. Based on substantial clinical data and evidence, the product is deemed safe, effective and able to be produced within federal quality standards.

The process for an Emergency Use Authorization (EUA) is different than an FDA approval. EUA is a mechanism used by the FDA to facilitate making products available quickly during a public health emergencies (like the current COVID-19 pandemic), when there is no other adequate and approved medical product available.

Emergency Use Authorization allows for the use of medical products that are not yet formally approved, so that in the midst of an emergency, the products can be used to diagnose, treat or prevent serious illness or conditions. In order to give the authorization, FDA evaluates the potential risks and benefits of the products based on the scientific evidence that is available at that time. EUAs end when the emergency declaration ends. They can also be revised or revoked as more data is made available.

Context and background

On February 4, 2020, the United States Department of Health and Human Services declared a public health emergency based on the new coronavirus that was detected. They also declared that circumstances existed to justify the authorization of emergency use diagnostic tools. Further, the FDA issued guidances with immediate effect on developing emergency use diagnostic testing abilities. Over the last several months, FDA has issued guidances on Emergency Use Authorization for several medical products, including ventilators, respiratory devices, disinfectants, masks, sanitizers and now vaccines.

Used with permission by Health Desk, a public health hub that explains emerging COVID-19 science.

This article was written and edited by the Tayo editorial desk and has been reviewed by an independent panel of subject matter experts.

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