Did you know that emergency use authorization (EUA) can be granted by the Food and Drug Administration in times of public health emergencies? This significant authorization permits the use of medical products that are yet to be approved or the employment of approved medical products for unapproved purposes.
The purpose of emergency use authorization is to effectively diagnose, treat, or prevent life-threatening diseases. But what is emergency use authorization exactly, and what specific criteria must be satisfied to attain the EUA status? Keep reading for everything you need to know.
Key Takeaways
- EUA allows providers and public health officials to use unapproved diagnostic, treatment, or prevention measures to counteract a national security threat, such as a pandemic.
- Health officials must follow specific steps and meet certain criteria to have the FDA approve a EUA.
Emergency Use Authorization Background
The Project BioShield Act created the EUA program in 2004 to protect the public or U.S. military during a significant threat to national security. During an emergency, the FDA reviews the potential benefits and risks of providing emergency use authorization to the public while ensuring the EUA’s safety, efficacy, and security.
Emergency Use Authorization Benefits
EUA allows public health officials and physicians to quickly mobilize the best diagnostic, treatment, and prevention measures available during emergency situations. Under EUA, these measures do not have to be FDA-approved or approved for their particular use. For example, the FDA may have approved a device to diagnose a certain virus, which we’ll call Huddle Virus.
During an emergency situation such as a pandemic, it may turn out that this device could help diagnose the virus that’s causing the pandemic. Although the FDA approved the device to only detect the Huddle Virus, the organization may approve emergency use authorization for providers to use this device to detect the virus that’s causing the pandemic.
Steps to EUA
Here are the steps to activating emergency use authorization:
- Determination of an emergency: Made by HHS, Department of Homeland Security, or Department of Defense
- Declaration of an emergency: Any variety of emergency that threatens national security
- Review of the request for EUA by the FDA
- Issuance of the EUA or denial of the request
- Termination of the emergency use authorization
Criteria for EUA
Emergency use authorization must meet four criteria for the FDA to even consider approval for use.
- There must be a serious or life-threatening illness known to be caused by a certain microbe (e.g. virus) or chemical, nuclearm or radiological agents.
- It’s reasonable to believe that the medical product approved for EUA will be effective for its intended use.
- The benefits, or potential benefits, of the product used under emergency use authorization must outweigh the risks or potential risks.
- The product is the best countermeasure against the threat causing the emergency.
EUA in Action
The FDA has used EUA during the following outbreaks:
- Anthrax
- H1N1 (swine flu)
- H7N9 influenza
- Coronavirus
- Ebola virus
- Enterovirus D68
- Zika virus
- Covid-19
Final Thoughts
What is emergency use authorization (EUA)? This crucial service aids the world during public health emergencies. Emergency use authorization grants permission to use unapproved medical products or unapproved uses of already approved medical products. EUA enables the prompt diagnosis, treatment, and prevention of life-threatening diseases.
By adhering to specific criteria, emergency use authorization empowers healthcare professionals to swiftly address urgent medical needs, ensuring the well-being and safety of the population in times of crisis.
Sources
- FAQs on Emergency Use Authorizations (EUAs) for Medical Devices During the COVID-19 Pandemic | CDC
- Emergency Use Authorization (EUA) information, and list of all current EUAs | CDC
- Medical Countermeasures Dispensing: Emergency Use Authorization and the Postal Model, Workshop Summary. | The National Academies
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Reviewed by Geetika Rao, MPH | Edited by Nidhi Mahagaokar, MPH | Fact checked by Julia Radossich, PA-C