- Posted by Melissa Nickel and Chris Justice
- On April 21, 2020
How do medical device R&D leaders get a product to market quickly in emergency situations like the COVID-19 pandemic, with a 90+ day 510(k) approval timeline to consider? Our medical device industry has the power to do great good during a health crisis; R&D leaders must do so in ways that are also sustainable for long term product line viability. FDA Emergency Use Authorizations (EUAs) can be helpful in the short term, but R&D leaders have to ensure that utilizing an EUA does not endanger long term product viability. We’ve compiled our collective expertise to assist R&D leaders in answering this question, drawn from our experience creating medical devices (Electrical, Mechanical, and Embedded Software Systems) for our customers.
What is an EUA?
An Emergency Use Authorization (EUA) allows the U.S. Food & Drug Administration (FDA) to authorize emergency use of certain medical products. This is most often used to support emergency situations (such as the COVID-19 pandemic) and foster the development and availability of medical products for use in these emergencies. In some cases, normal FDA approval processes are modified under EUAs to enable swift availability of much-needed new products to react quickly during times of urgent need.
These medical products are commonly referred to as “medical countermeasures” or “MCMs”. This could include test kits, vaccines, devices, personal protective equipment.
How Have EUAs Been Used in the Past?
The FDA released the most recent version of EUA guidance in 2017; it was in place before COVID-19 providing historical context of what to expect after this present pandemic is over. This guidance allows the FDA to authorize the emergency use of an unapproved medical product or unapproved use of an approved medical product for certain emergency circumstances.
Examples of other times that EUAs have been implemented were for emergencies such as H1N1 (2010), Anthrax (2011), Ebola (2015), Zika Virus (2016). In our experience, the FDA strikes a good balance between meeting these urgent and extraordinary needs, while still appropriately regulating safe and effective medical products/devices.
What EUAs Have Been Issued for COVID-19?
Early in February 2020, the FDA determined that there was significant potential for a public health emergency allowing for Emergency Use Authorizations (EUAs) for COVID-19 medical countermeasures. As a result of this determination, as of April 15, 2020, there have been 8 EUAs related to Personal Protective Equipment (PPE), more than 50 related to testing and 6 for ventilators/other medical devices for COVID-19.
How Long Do They Last?
The FDA will terminate EUAs when they determine that the emergency has passed or the product has been officially approved by the FDA through its normal processes (such as the FDA’s 510(k) or Premarket (PMA) Approval processes). No timeline has yet been published by the FDA for the end of the present COVID-19 EUAs.
What Happens to the Products Produced Under the EUA?
When an EUA is revoked or terminated, the unapproved product must be disposed. There is no grandfather mechanism to allow the product to continue being used after the emergency has passed (see page 29 of guidance). If a company intends to continue making or selling products released under an EUA, they must submit an application for the approved use of the device through the standard FDA approval processes such as 510(k) or Premarket (PMA) Approval.
How to Continue Producing Devices After an EUA is Terminated?
We have compiled the following recommendations for medical device R&D leaders intending to create products that can continue past an EUA.
- Use design controls and manufacturing controls, documenting along the way. This investment will pay off in the long run, and we don’t find these controls overly burdensome when weighed against the benefits!
- Clearly label devices as released under the EUA for easy identification and compliance with product disposition requirements once the EUA is retracted.
- Assign specific (and distinctive) part numbers or model numbers for any EUA product. This will make tracking much easier.
- Track shipments and distribution, as with any medical device. Know where EUA devices are located and take extra precautions to follow devices in the field.
- Start the standard approval process, such as the 510(k), in parallel with marketing under the Emergency Use Authorization.
- Utilize expedited review available from the FDA for certain categories of devices, such as ventilators. This can be a good way to accelerate the standard 510(k) process when there is a sense of urgency at the agency level.
- Where strategic, consider alternatives to device destruction. We are not aware of devices that have been first authorized under the EUA and later approved unchanged under 510(k), but we see no reason a compliant process and product could not be transitioned from EUA status to 510(k) status.
At Engenious Design, we create medical devices for our clients who are medical device manufacturers. Our specialties include Electrical, Mechanical and Embedded Software Systems. We have experience in FDA Class I, II, III and PMA Devices. Firms, such as Engenious, can help handle the surge in demand for specialized design and test work to accommodate an EUA in parallel with a standard FDA approval process. Utilizing surge capacity at a firm like Engenious can be an effective way to keep internal R&D teams focused on core product development, while also meeting urgent needs presented under an EUA or during the course of normal new product development.
Establishing a longer-term relationship with a partner, like Engenious, provides an R&D leader and their medical device companies, an increased capacity when emergency opportunities are presented…allowing your organization to make a difference and fast! Important relationship-building and trust establishment can start with partnering on limited-scope projects when you’re in the middle of surge demand or if you want to position yourself ahead of it.