What is FDA Emergency Use Authorization (EUA) and how does it work?

When a global health emergency like the COVID-19 pandemic strikes, public health officials need to act fast. But health authorities must balance two responsibilities: how to act quickly, and how to make sure that treatments are as safe as possible.

Since the regular FDA approval processes can take years, one alternative solution is an Emergency Use Authorization – which is how many tests, treatments, and therapies have been authorized during the pandemic to help diagnose and treat COVID-19.

What is an Emergency Use Authorization (EUA)?

While the definition of a EUA on the FDA’s website may seem complicated, it’s a faster way for public health officials to deal with health emergencies.

During a public health emergency (declared by the United States Secretary of Health and Human Services), the FDA Commissioner can allow unapproved medical products or unapproved uses for approved products to be used to treat diseases or conditions that don’t have other alternative treatments.

An incident like the COVID-19 pandemic is considered a biological event, which is why it was considered a public health emergency. During the COVID-19 pandemic, EUAs can be granted for any product known as a medical countermeasure (MCM) that helps diagnose, prevent, or treat SARS-CoV-2, the virus that causes COVID-19.

What criteria does the FDA consider when issuing an EUA?

The FDA considers four criteria when it considers issuing an EUA:

  1. Serious or life-threatening disease or condition: The FDA determines if the cause of the public health emergency poses a threat to the general population.
  2. Evidence of effectiveness: This standard is lower than typical FDA approval and requires that the proposed treatment “may be effective”.
  3. Risk-benefit analysis: The FDA examines scientific evidence to weigh the risks and benefits of the potential product.
  4. No alternatives: Potential alternative products may be considered “unavailable” if there isn’t enough supply to meet the need, or “inadequate” if the treatment can’t be widely used the same way by all populations.

What happens to an EUA after the public health emergency ends?

It’s important to remember that an EUA is not a substitute for FDA approval. After the national emergency is declared over, the EUA also ends with that declaration. However, the FDA encourages the owners of products that were formerly authorized under the EUA to work toward full FDA approval.

The nasal PCR COVID-19 test from empowerDX is FDA Emergency Use Authorized, so you can get peace of mind knowing that your health is in authorized hands.

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