Sep 21, 2021 Ezra Kelderman

What is FDA Emergency Use Authorization

In recent months, the U.S. Food and Drug Administration (FDA) has used Emergency Use Authorizations (EUA) to accelerate the development and approval of medical devices and biopharmaceutical products to combat the global COVID-19 pandemic.

Under normal circumstances, the FDA approval process can take months to complete. In an emergency situation, however, the standard FDA approval timeline simply isn’t fast enough to meet the demand and need for potentially life-saving products.

COVID-19 underlined the importance of the EUA. In the midst of the pandemic, the FDA gave vaccines from Pfizer, Moderna, and Johnson & Johnson authorization for emergency use. To date, more than 63 percent of the U.S. population has received at least one dose of these vaccines.

In this article, we’ll introduce some of the basic components of the EUA and how medical device manufacturers, biopharmaceutical companies, and other healthcare innovators benefit from an EUA.

Overview: What is FDA Emergency Use Authorization?

Section 564 of the Federal Food, Drug, and Cosmetic Act (FD&C Act) grants the U.S Department of Health and Human Services (HHS) the ability to enact EUAs during significant public health emergencies. When EUAs are in place, life sciences companies can expedite the manufacturing of high-value medical countermeasures (MCMs).

 

However, the FDA still requires manufacturers to provide documentation related to the quality practices and procedures instituted during product development. To streamline this process, many scaling life sciences startups and scale-ups invest in an electronic quality management system (eQMS).

Qualio’s eQMS supports the quality and compliance objectives of industry-leading medical device manufacturers and biopharmaceutical companies. From improved document management to audit-readiness, quality teams rely on modern quality systems to improve internal efficiencies and performance.

FDA Emergency Use Authorization Criteria 

According to the Centers for Disease Control and Prevention (CDC), an EUA can only be issued when “there is no adequate FDA-approved alternative available.”

The product must be used to treat a widespread, life-threatening medical issue such as a global pandemic. Additionally, the manufacturer must present information related to the product’s overall efficacy and safety. Based on this data, the FDA will either confirm or deny EUA for the medical device or biopharmaceutical product.

For a complete ruling on EUA, please consult the FDA’s Emergency Use Authorization of Medical Products and Related Authorities.

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How to Apply for FDA Emergency Use Authorization

We recommend including the following information to obtain FDA EUA: 

  • A brief summary of the product’s intended use and therapeutic effectiveness
  • A brief summary of the product’s safety and any associated risks
  • Information related to packaging, labeling, and instructions for use
  • Information related to product manufacturing, including design and controls

It is the responsibility of the applicant to supply all pertinent information needed to appropriately communicate overall product safety and effectiveness.

For complete guidance on the EUA application process, including pre-EUA submission activities, please refer to the FDA’s Emergency Use Authorization of Medical Products and Related Authorities.

How to Improve Medical Device Quality With an eQMS

If you’re pursuing FDA emergency use authorization, don’t leave the quality of your medical device or biopharmaceutical product to chance. 

Last year, Qualio proudly announced its new Quality Management Initiative for Coronavirus and COVID-19.

“As a distributed team working remotely throughout the United States and Europe, Qualio is announcing our support for any company working on therapeutics, diagnostics, vaccines, or devices related to COVID-19,” Qualio CEO Robert Fenton said at the time. “With expertise in distributed working, quality management, and regulatory compliance, we are uniquely positioned to help, and we are now providing discounted Qualio accounts to new customers combined with world-class quality and regulatory expertise for all qualifying companies.”

How does your current QMS support your FDA EUA efforts? 

If you’re thinking about making the switch to a modern, cloud-based eQMS, we recommend scheduling a live demo of Qualio with one of our quality experts. 

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Published by Ezra Kelderman September 21, 2021