End of the Line for EUA: Are You FDA Ready?

Bernhard Kappe
Bernhard Kappe

Executive Summary

The Emergency Use Authorization (EUA) period is ending. Medical device products that received EUA clearance need to prepare for standard FDA submission or face mandatory removal from the market. Orthogonal can help prepare you for FDA submission so you can avoid losing money and potentially harming patients.

 


 

An urgent need for life-saving medical products and novel applications of existing medical problems to combat the COVID-19 pandemic led the FDA to invoke Emergency Use Authorization (EUA). Under EUA, “FDA may authorize unapproved medical products or unapproved uses of approved medical products to be used in an emergency to diagnose, treat, or prevent serious or life-threatening diseases or conditions caused by CBRN[1] threat agents when certain criteria are met, including there are no adequate, approved, and available alternatives.”[2] Practically, this meant an abbreviated process for applying for clearance to get your product in the market if there was no alternative already available.

As the pandemic subsides, the FDA will transition back from EUA to the normal and more thorough approval/clearance process. While the final dates have not yet been given by the FDA, many industry observers project that this will happen no later than the third quarter of 2022.[3]

Medical device companies that received EUA will need to work towards a full FDA submission, either a 501(k), De novo or PMA. Having received EUA doesn’t grant you an exception from the standard process, but the real-world experience your product had – and the data it generated – will be an advantage going into your next submission.

Depending on how you built and operated your medical device, you may find the standard FDA submission process manageable. If you followed all the standards, collected real-world data to demonstrate safety and effectiveness, built your software under design controls and did appropriate risk management, you are in a good position to submit and receive full authorization. 

Your organization must also be ready to face new challenges on a deadline. To gauge how prepared you are for the end of EUA, read and answer the following questions: 

  • Are your R&D, software, quality and regulatory programs all in alignment on how they will come together to safely navigate this end-of-EUA glide path without costly stumbles?  
  • Do you have all the technical staff and skills you need on hand to deftly face down any obstacles in the coming months/year?
  • And if your answer to the above questions is “Yes,” would you like to get a quick validation that your team is fully ready for these coming challenges and (still unknown) deadlines?

But what if, in your race to help combat the pandemic, you expedited your processes? What if you didn’t take the time for proper documentation or accelerated through laying the foundation of software architecture? You may be forced to abandon your product, which could lead to lost revenue, loss of financial backing, risk of harming patients or having your device be supplanted on the market by a competitor. In a worst case scenario, you could face regulatory or administrative sanctions from the FDA.

Time is running out to get your medical device up to industry standards or face mandatory removal from the market. Orthogonal can help you get your device up to speed before EUA ends. We apply fast feedback loops to verify and validate the user experience of your product and design and perform any needed risk mitigations. We are experts in crafting quality documentation required for traditional submission pathways. We can also engage product analytics to ensure you are collecting in-use data that speaks to the safety, effectiveness and robustness of your product. Together, we can help you get your medical device through FDA clearance so you can avoid losing revenue and leaving patients in the lurch. 

Contact us now to gain the most effective partner for Software as a Medical Device (SaMD), Digital Therapeutics (DTx) and connected medical device systems remediation. 

Want to learn more about the EUA? Read our FAQs. 

 


Emergency Use Authorization FAQs

What is EUA?

EUA, which stands for Emergency Use Authorization, is an authority that allows the FDA to make available unapproved health protections in times of a public health emergency. EUA can be granted to an unapproved medical product or to an approved product that is to be used in an unapproved way. This authority is granted under section 564 of the Federal Food, Drug, and Cosmetic Act (FD&C Act).

Why Did EUA Happen?

The conditions of the spreading COVID-19 pandemic caused the Secretary of Health and Human Services (HHS) to declare an EUA was appropriate. This allowed the FDA to permit the use of unapproved medical products or approved products for unapproved purposes as long as there are no approved alternatives in the market. COVID-19 is not the first use of EUA,[4] but it is the biggest to date and the most well-known.

When is EUA Ending?

It is not known specifically when EUA will end, but with pandemic numbers decreasing the FDA could announce cessation of EUA at any time. According to the Associated Press,[3] the current public health emergency, which has been renewed periodically since first instituted in early 2020, is scheduled to end on April 19th, with the expectation that the Biden administration will extend it through mid-July. In addition, as time has passed during the pandemic, a fully authorized alternative to your EUA product could be brought online through regular authorization, which may impact the end of your EUA specifically. 

Currently, the FDA is collecting public comments on a draft document on how EUA will end. The FDA seeks comments on if a 180-day advanced notice period is sufficient for the transition from EUA to regular FDA approval/clearance. 

What Products Received EUA?

As of July 2021, over 600 EUAs have been granted due to COVID-19, which is more than all prior grants combined.[5] 

The FDA granted EUAs in three major categories of products:

  • Vaccines
  • Drugs and Non-Vaccine Biological Products
  • Medical Devices

Some examples of each are as follows:

  • Vaccines
    • Pfizer-BioNTech COVID-19 Vaccine
    • Janssen COVID-19 Vaccine
  • Drugs and Non-Vaccine Biological Products
    • Bebtelovimab
    • Lagevrio
  • Medical Devices
    • Lucira CHECK-IT COVID-19 Test Kit
    • iHealth COVID-19 Antigen Rapid Test

The Need to Complete Full Authorization or Abandon the Product

When EUA ends, you will need to proceed with traditional product authorization or you will be required to abandon your product, cease distribution and recall it from the field. If you have been compiling a design history file (DHF) as you go and are prepared to share data regarding safety and effectiveness of the product gained under the EUA, you are probably in good shape for a submission. If you have not been following these requirements, you will likely need to remediate as soon as possible

What Approaches Will Work as EUA Ends?

Methods that accelerate product development and risk mitigations, enable data collection and provide essential quality tracking information such as a design history file will be most effective when dealing with the end of EUA.

References

1. Chemical, biological, radiological, and nuclear.

2. Emergency Use Authorization. U.S. Food and Drug Administration. https://www.fda.gov/emergency-preparedness-and-response/mcm-legal-regulatory-and-policy-framework/emergency-use-authorization. Published 2022. Accessed April 5, 2022.

3. COVID pandemic's end may bring turbulence for US health care. AP NEWS. https://apnews.com/article/covid-health-business-coronavirus-vaccine-medicaid-fbb66b72937f3517a5d3d1ba8840f339. Published 2022. Accessed April 5, 2022.

4. Emergency Use Authorization (EUA) - All Items. Phe.gov. https://www.phe.gov/emergency/news/healthactions/Lists/EUA/AllItems.aspx#InplviewHash2c607005-403d-4aff-b93e-aaeba49eccdf=SortField%3DDate-SortDir%3DDesc. Published 2013. Accessed April 5, 2022.

5. After 600 emergency use authorizations for COVID, experts worry the FDA has gone too far. Fortune. https://fortune.com/2021/06/07/covid-emergency-use-authorizations-fda-euas-therapies-drugs-medicines-pandemic/. Published 2021. Accessed April 5, 2022.

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