Emergency Use Authorization (EUA) authority is a valuable tool in the FDA’s arsenal allowing them to respond quickly to a public health emergency, such as emerging infectious diseases, in order to save lives. It is an authority that was used aggressively in 2020 due to the emergence of the coronavirus pandemic, which quickly swept across the country.

The EUA authority can be used for medical devices, pharmaceuticals, and in vitro diagnostic tests. It is specifically worded to “allow the use of unapproved medical products, or unapproved uses of approved medical products, to diagnose, treat, or prevent serious or life-threatening diseases when certain criteria are met, including that there are no adequate, approved, and available alternatives.”

In essence, an EUA authorizes the use of a product that has not yet been cleared for use at all or allows an approved product to be used outside the scope of its current approval.

The History of the Emergency Use Authorization Process

The Federal Food Drug and Cosmetic Act (FDCA) of 1938 first authorized EUA’sr in the event of pandemic occurrences. The scope of the authorization was then further expanded to include cases of chemical, biological, radiological, and nuclear agents.

Under these types of emergency circumstances, the FDA can enable access to drugs, devices, and biologics based on less data, including abbreviated analytical and clinical validation, than is normally required for approval.

An EUA allows doctors and patients access to treatments and diagnostics when:

  • The overall evidence for a specific test or treatment shows that  it is reasonable to believe it will be an effective option to treat or diagnose the condition or disease
  • Its potential benefits outweigh the risks
  • There are no alternatives which are approved, adequate and available

EUA’s – Powering Care during COVID-19

The importance of EUA’s has become particularly apparent during the current COVID-19 crisis. In fact, the FDA has issued EUA’s for everything from respiratory assist devices, vital to treating severe COVID-19 patients, to antiviral drugs, like Remdesivir, and tests to detect SARS-CoV-2, allowing the nation to respond and adjust strategies based on accurate case numbers of the disease.

Due to the fact that SARS-CoV-2 was a novel virus, rapid testing was not available at the beginning of the pandemic. In addition to that, the demand quickly outpaced the testing capacity of our country’s public health labs.

To combat this challenge, the FDA has used the EUA authority to leverage regulatory flexibility for developers in the commercial and laboratory sectors to ensure that comprehensive and accurate testing is available for all who need it. The FDA has made a point of offering widespread support for expedited access to COVID testing for this specific reason since any effective pandemic response requires the availability of accurate diagnostics.

Saving Lives in the Face of a National Emergency

All of this has made EUA one of the most important powers the FDA possesses to protect the safety of Americans.  This authorization plays a vital role in guarding health and saving lives. Wellacy uses the highest quality and data-supported protocols and diagnostic tools – including EUA point-of-care tests. With your health in mind, Wellacy is able to provide health answers in minutes. Are you ready? To make an appointment at the Wellacy’ MD RV, visit www.wellacy.com. Hours of operation are Monday through Saturday 9:00 am until 9:00 pm. Sunday 9:00 am until 6:00 pm.


Respiratory Assist Devices EUAs – FDA

FDA Support For Expedited Access To COVID-19 Diagnostics – Health Affairs

FAQs on Emergency Use Authorizations (EUAs) for Medical Devices During the COVID-19 Pandemic – FDA

Information for Laboratories Implementing IVD Tests Under EUA – FDA

Gilead’s Investigational Antiviral Remdesivir Receives U.S. Food and Drug Administration Emergency Use Authorization for the Treatment of COVID-19 – Gilead

Emergency Use Authorization – FDA

Coronavirus Disease 2019 (COVID-19) Emergency Use Authorizations for Medical Devices – FDA


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