Companies, organizations, and initiatives around the world have mobilized to seek out solutions addressing the COVID-19 pandemic. For companies looking to introduce medical devices for COVID patients in the US, this means not only developing a product itself, but obtaining emergency authorization from the FDA to manufacture and distribute life-saving equipment across the country.
So why is Emergency Use Authorization, or EUA, necessary? What does it mean to have a product that meets this standard?
During situations when products are being quickly developed to deal with serious threats to public health, a state of emergency is declared by the Secretary of Health and Human Services (HHS) at the White House, and an EUA becomes available as a streamlined form of temporary authorization for medical devices that can protect from or provide relief during the crisis.
The FDA’s traditional regulatory pathways can take millions of dollars and years of testing at different facilities. EUA, however, is designed to provide quick access to Medical Countermeasures, such as drugs, diagnostic tests, and other devices that could immediately start saving lives when there are no currently approved options, or if there is a shortage of available products on the market.
While EUA is a quickly processed and temporary form of authorization, it is by no means inadequate. The FDA is the highest oversight body in the country, and patient safety is given precedence over all other aspects of design when it comes to authorizing a medical device for an emergency situation.
In 2015, for instance, the Ebola virus testing provided through the CDC was granted an EUA; a crucial measure considering that the symptoms of early-stage Ebola (like many cases of COVID-19) are very difficult to diagnose. A similar situation played out in 2017, when several organizations such as Thermo Fisher Scientific and the Center for Infection and Immunity at Columbia University were quickly authorized to distribute tests for Zika virus. There are countless examples of how EUA has been used by companies and organizations in the past during times of public health crisis, all of which you can read about on the FDA’s website.
During the coronavirus pandemic, more EUAs have been issued than ever before. Authorizations are open for products such as masks, gloves, diagnostic tests, and ventilators. At The Ventilator Project, we’re answering the call to develop a ventilator for COVID-19 patients to alleviate the nationwide shortage.
The FDA has different requirements for different types of medical devices. A ventilator is designated as a class II medical device, for which the standard regulatory pathway would be a 510k clearance.
TVP is using two core documents of design standards (based on FDA standards 60601 and 80601) created by the Association for the Advancement of Medical Instrumentation (AAMI) to build our FDA submission. Both are about 600 pages long under normal circumstances, but with the streamlined EUA process, they’re trimmed down to about 100 pages each.
Not only is the process for getting a submission together more streamlined, the time it takes for the FDA to review the submission and issue the authorization is accelerated.
Once a submission is put together for a traditional 510k, the amount of time the FDA takes to review it varies, but it generally falls at around 90 days. By contrast, an EUA submission can be processed in a couple of days or even hours.
This makes the goal of manufacturing and distributing a ventilator to save the lives of COVID-19 patients attainable, but it is by no means an easy feat.
“Going through [the AAMI documents] has taken an entire army,” says Peter Choi, head of the Quality and Regulatory team at TVP.
Choi’s department manages regulatory policies, and is in the process of preparing TVP’s FDA submission.
“My team has about 30 people, and we go through these documents on a daily basis, looking at protocols and determining whether or not our ventilator is on the right track. Often, we collaborate with engineering to figure out if we’re going in the right direction—is it legal, is it safe for patients?” Choi says.
“We’re also collaborating with Project Management to ask, even if it’s legal, is this feature sufficient enough that people want it? Having to find that balance is always incredibly difficult.”
An EUA is situational, and many of the traditional regulatory components and requirements are altered and modified by the White House. As requirements are adapted over time, regulatory professionals and manufacturers must continue to interact with FDA reviewers to ensure all standards are being met. But EUA undeniably vital for public safety. It allows manufacturers to innovate and quickly provide the most necessary medical equipment to hospitals and healthcare centers while still ensuring patient safety. The authorization only lasts as long as the crisis at hand, but all devices can later apply for permanent authorization through a tradiational regulatory pathway, and the FDA encourages companies to get ahead on their 510k submissions while the EUA is in effect.
As The Ventilator Project enters the final stages of preparation for an EUA submission, we’re excited to anticipate a quick turnaround that will get our ventilators into undersupplied hospitals within a matter of days. But we’re also looking forward to what comes after that. With 510k clearance, more affordable devices will become available to hospitals in the long run, ensuring that the shortages of emergency equipment we’re experiencing now will never happen again.
