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Author: Anne Holland, CEO and Founder

One does not generally think of the U.S. Food and Drug Administration (FDA) as a fast-moving, rapidly changing organization. However, their responsiveness to the public health risk of COVID-19 tells a different story.

On February 4, 2020, the Secretary of the Department of Health and Human Services (HHS) issued a determination of public health emergency, which included the Emergency Use Authorization (EUA) for COVID-19. The EUA has since been expanded to cover 10 categories of products, including these medical device types: diagnostic, non-diagnostic, therapeutic, infusion pumps, personal protective equipment (PPE), and other devices such as ventilators.

This responsiveness from the FDA, and willingness to work directly with companies to allow products to enter the market swiftly, is unprecedented in my experience. While there are many benefits to EUAs, there are risks for both the healthy and those suffering during the pandemic.

This policy change is in keeping with the FDA’s 2020 Mission: “Protecting consumers and advancing public health by maximizing compliance of FDA regulated products and minimizing risk associated with those products.”

What are the EUA Requirements for PPE?

Let’s look at an example of the EUA in the real-world for PPE, such as masks, respirators, and gowns, used by healthcare providers and the public. How does the EUA process work and what are the key things that you should be aware of?

If you plan to market an EUA product, here are some important takeaways to learn from how the EUA regulations were utilized for PPE during this crisis:   

  • Consider that EUAs are temporary and only last during the outbreak or until revoked. A long-term strategy for marketing a product should also be developed.
  • Keep up with the EUAs for your product of interest and focus on the scope of each EUA for a complete understanding. For example, the EUAs for face masks and respirators (N95 masks) changed frequently, so it was challenging to keep up with the requirements. It can be confusing as EUA requirements differ whether the product is a surgical mask, an N95 respirator, or a cloth mask for public use. Several EUAs were issued or revised throughout March, April, May, and June 2020, which has further complicated understanding of the EUA pathway for these products. Staying current with the changes as they occur will help ensure you are correctly managing the sale of your product under EUA.
  • Demonstrate the product works as intended and document as such. Although the FDA has waived requirements such as registration and listing, full quality management systems, and unique device identification for EUA products, it is up to the manufacturer to ensure the device is safe and functions as required. You will be required to provide documentation once the EUA expires, if you plan to continue to market the product.
  • Ensure that the product is labeled correctly. The labeling claims of EUA devices is critical so that the product is not misrepresented, and the risks are clearly described.
  • Understand the risks. As can be expected with loosened regulatory requirements, there are a few troublemakers who ruin the opportunity for the many. In May 2020, the FDA issued a letter revising an EUA because respirators did not meet the test requirements for filtration based upon testing by independent labs. Proactively identifying and mitigating risks associated with your EUA product will avoid the burden of remediating any overlooked risks as the FDA continues to add more stringent requirements to EUAs when a few “bad seeds” take advantage of the lenient authorizations.
Looking for Quality and Compliance Know-How to Launch a Medical Device During the Coronavirus Pandemic?

For more than 20 years, QA Consulting has been a trusted partner for innovative quality assurance and medical device regulatory affairs consulting. Understanding the nuances of the ever-changing regulatory environment is critical to the success of your business.

Contact us today to discuss how to market your medical device under the FDA’s evolving emergency use authorization (EUA) regulations.