What Happens to Your Medical Device When the FDA’s Emergency Use Authorization Ends?
Throughout the COVID-19 pandemic, the FDA has issued hundreds of Emergency Use Authorizations (EUAs) to medical devices. EUAs allowed each of these products to fast track their approval in order to serve the public during a tumultuous, unprecedented, and sometimes dangerous time.
But now that COVID isn’t looming as large in the United States and some manufacturers have caught up with the increased demand for certain medical products, it’s only a matter of time until EUAs end.
If your medical device company developed a product under an EUA, you probably want to know what’s next. And even if the EUAs weren’t relevant to you this time around, you’re a smart, forward-thinking leader. You recognize that, unfortunately, another emergency situation could be right around the corner — and you should be prepared.
That’s why we’ve summarized everything you need to know about EUAs and the future of medical devices during emergencies like COVID-19. Plus what you should be aware of when those emergencies come to a close.
A Detailed Look at Emergency Use Authorizations
The EUA is used by the FDA to facilitate the availability of medical countermeasures (MCMs) during public health emergencies.
MCMs include:
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Drugs (e.g., antivirals and antidotes)
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Biological products (e.g., vaccines, blood products, and biological therapeutics)
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Devices (e.g., in vitro diagnostics and personal protective equipment)
In simpler terms, this means medical devices that fit the qualifications of the EUA may fast track their approval to get their products into the hands of in-need populations.
But who decides when an event is a public health emergency? That’s up to the federal government, including the Secretary of Health and Human Services (HHS). Using COVID-19 as an example, the US government named the virus a public health emergency on January 27, 2020, after confirming several cases. That set HHS in motion and paved the way for EUAs.
The EUA can be applied to unapproved, novel products but also to unapproved uses for already approved products.
Finally, know that the EUA does more than allow the FDA to approve products for use. It also has the power to:
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Extend the expiration date of eligible stockpiled MCMs
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Waive good manufacturing practices (such as storage and handling regulations) for emergency needs
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Permit emergency dispensing of MCMs during an emergency event
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Allow the CDC to create and issue “emergency use instructions”
How Long Do Emergency Use Authorizations Typically Last? What About the COVID-19 EUAs?
In general, EUAs end when the circumstances that determined the public health emergency no longer exist or when only a single product has EUA and has since been fully approved by the FDA.
On April 15, 2021, the FDA renewed their determination that a public health emergency exists because of the COVID-19 pandemic, meaning EUAs can still operate. However, there’s no way to determine exactly how much longer these EUAs will stay open, even with this renewal. In fact, the FDA has the power to revise or revoke EUAs at any time.
Because emergency situations are always unpredictable, you should be preparing for EUAs to lapse basically the moment they’re announced.
What Happens When EUA Ends and You’re Unprepared?
Imagine there’s a shortage of tongue depressors during an emergency and an EUA is issued. As a result of the EUA, popsicle sticks are deemed appropriate substitutes for tongue depressors. Popsicle stick manufacturers jump at the opportunity to sell their existing product to a new customer base — medical professionals.
However, once it’s announced that the EUA will end, these popsicle stick manufacturers start to panic. They don’t want to lose this new line of revenue they’ve invested in, but without the EUA they can’t legally market popsicle sticks as tongue depressors. They risk a major loss of funds if they have to pause production — or, worse, stop completely.
This is perhaps an extreme example. If the COVID-19 EUAs are relevant to you, you’re probably already a medical device company, not a company in a totally separate industry. Still, this scenario plainly illustrates what could happen when the real EUAs end: a gap or total stoppage in the expensive production of your EUA-developed product(s).
What Are the Options for Your Medical Device Post-EUA?
If you’re concerned about the end of COVID-19 EUAs or you’re curious about next steps post-EUA in general, you essentially have two initial options to choose from:
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Stop creating/manufacturing the EUA-developed product when the EUA ends, or
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Prepare the appropriate premarket submission for the FDA.
The vast majority of medical device companies, especially larger developers with ample resources, prepare their premarket submission. This basically means they’re getting their EUA-developed product ready for full FDA approval.
Ideally, and as the FDA recommends, you should work on your premarket submission while the public health emergency, like COVID-19, is still in effect. That way, you won’t face those costly pauses in production when EUA ends. Instead, you can market your product seamlessly.
And what does a premarket submission entail? It depends on the specifics of the medical device in question, including its classification. There are a few paths you can pursue, such as:
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510(k) submission
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De Novo request
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Premarket authorization
In sum, if your company developed a medical device under a recent EUA, you want to continue to market it in perpetuity, and you aren’t taking steps toward your premarket FDA submission, act now.
And for everyone else, know that EUAs don’t last forever. If you ever find yourself marketing an EUA-developed device, don’t wait to put together your premarket submission until the EUA lapses. Instead, think ahead so you never miss a day of production.
