How can Medical Device Companies use the Emergency Use Authorization (EUA) to Address the COVID-19 Pandemic?

From facemasks to ventilators, the medical device industry has the potential to lead the response to the COVID-19 pandemic. For companies developing new devices, or for companies making modifications to existing devices, how can companies get these devices to market quickly to benefit the growing number of COVID-19 patients who need them?

The Emergency Use Authorization (EUA) is one regulatory mechanism some have used successfully to bring devices to market quickly. But is the EUA the only option? What are the requirements of the EUA and how do we use it? Does the EUA mean a lower regulatory burden, i.e., less testing and faster to market compared to other pathways?

In an attempt to get devices to patients who need them, FDA is “relaxing the rules” for more devices including infusion pumps, clinical thermometers, extracorporeal membrane oxygenation and cardiopulmonary bypass devices, and remote ophthalmic assessment and monitoring devices. As the current health emergency continues, more devices will likely be added to this list.

But it’s not enough for companies and FDA to respond quickly… We must also respond correctly. What’s worse: not having enough ventilators OR having ventilators that don’t work? Regrettably, we are already seeing cases of this happening. There are reports of hundreds to thousands of ventilators that don’t work! How do we meet the regulatory and quality requirements that ensure devices are safe and effective while at the same time making sure these devices are available quickly to the increasing number of people who need them?

FDA has now issued nearly as many warning letters to companies marketing products for coronavirus as the number of EUA’s issued thus far! Why is this important? Simple. The more warning letters, the more scrutiny FDA will apply to future EUA applications meaning more supportive evidence will be required and the longer the time to review.

In this workshop, we will explore the Emergency Use Authorization — specifically in the context of COVID-19 — and how device companies can use it.

Using the case study approach, these questions and others will be presented in an interactive fashion including:

• What is the Emergency Use Authorization (EUA) and how do we use it?

• Which devices qualify for the EUA and which do not? Does it matter if it’s an existing device or a new device?
• What are the regulatory requirements for the EUA and what’s the process for applying?
• What are the testing requirements for the EUA and how do we find them? How much evidence is required for an EUA?
• If the EUA is not applicable, what other options exist?
• What are the quality and validation requirements for COVID-19 related devices?
• How should we modify our QMS for devices used during the COVID-19 crisis?
• How do we handle devices coming back from the field, i.e., devices recalled from hospitals?
• What happens to devices with EUA after this public health crisis is over?
• How can a company get their device authorized quickly without the risk of receiving a warning letter later?

Bottom line: Like all pathways to market, the EUA has the potential to get lifesaving medical devices to patients quickly who desperately need them. But if used improperly, the EUA has the potential to make things even worse than they already are. It’s up to us as medical device professionals to use the EUA responsibly to achieve speed to market and safety at the same time!

Who should attend?

• Medical Device Executives

• Regulatory Affairs Professionals and Management

• Quality Professionals and Management

• Clinical Affairs Professionals and Management

• R&D Engineers and Management