Emergency Use Authorization FDA
The medical device development process is arduous and expensive. Apart from the time it takes to design a product, extra attention must be dedicated to meeting device regulations. While the normal clearance process is relatively streamlined, it’s sometimes in the government’s best interest to reduce the burden on a device getting to market in times of urgency.
When an imminent threat presents itself and there are insufficient medical countermeasures (MCMs), the Food and Drug Administration (FDA) Commissioner is allowed to call for an FDA Emergency Use Authorization (EUA). An EUA allows the use of unapproved medical devices or approved medical devices in unapproved ways. They are typically issued in one of two scenarios:
- Company-specific authorizations – A medical device development company submits a request stating that they should be allowed to develop a certain device that the general public cannot (e.g., blood purification machines, mask decontamination products).
- Blanket Authorization – As long as a company complies with general requirements, their product is considered to be accepted (e.g., surgical masks).
These products are then used to diagnose, treat, or prevent a variety of conditions that could not have been dealt with otherwise. EUAs are for emergencies when there are no existing solutions to deal with a chemical, biological, radiological, or nuclear (CBRN) threat.
EUAs are part of section 564 of the Federal Food, Drug, and Cosmetic Act (FD&C Act). Only the commissioner has the authority to decide what qualifies for an EUA. Section 564 has been amended multiple times to keep up with the ever-changing field of medicine. Some examples of amendments to the FD&C Act include:
- The Project Bioshield Act of 2004 – This law provided additional funding to support the development of MCMs and created EUAs.
- The Pandemic and All-Hazards Preparedness Reauthorization Act of 2013 (PAHPRA) – This law recognized the FDA’s role in responding to a CBRN agent and allocated resources to fund public health emergency preparedness.
- Public Law 115-92 of 2017 – This law allows the Department of Defense to request help from the FDA in dealing with CBRN agents as well as agents that are associated with life-threatening risks to the U.S. military.
Guidelines for EUA Approval
When EUAs were first developed, they were not yet needed. The Project Bioshield Act of 2004 was a preemptive strike to prepare for natural pandemics and/or acts of terrorism. They were created to optimize medical responses in times of need by enabling manufacturers of medical devices to operate outside of the normal regulations. An EUA allows product developers to focus solely on solving a problem that needs immediate attention.
There are five steps to the FDA issuing an Emergency Use Authorization:
- The nature of an emergency is determined
- A state of emergency is declared
- FDA review of EUA medical device request
- The issuance or denial of the EUA request
- The EUA terminates
The departments of Health and Human Services (HHS), Homeland Security (DHS), and Defense (DOD) are the only three bodies that can determine an emergency for the FDA. If any type of military, domestic, or public health threat affects national security, it can be ruled an emergency. Threats can also be emergencies if they pose a significant potential to affect national security. The determination and declaration must both make evident the nature of the threat (chemical, biological, radiological, or nuclear).
Once an emergency has been determined and declared, EUA applications are submitted that outline the intentions of a developer and specifics about the device they plan to build or use. The FDA looks over these submissions and decides whether or not to provide medical device authorization given the current circumstances. If FDA emergency authorization is issued, this EUA will continue until the emergency declaration it is linked to expires. One declaration can be attached to as many EUAs as necessary.
It’s not possible to fully prepare a proper EUA application in advance of the emergency because the EUA requirements are decided after the emergency is declared. The information necessary for authorization is dependent on the severity of the emergency. The request generally includes specifics about the device – what it does; who it’s intended for; and how it will be distributed. The FDA must have an idea of what they’re allowing and whether or not the developer will actually be able to follow through.
EUA and COVID-19
Originally, EUAs were expected to be a counterterrorism measure; they would allow the DHS and DOD to utilize the FDA’s resources if an attack were to occur. Since implementation, however, EUAs have mostly been used for pandemics. The first major wave of authorizations came with the H1N1 virus, or swine flu; most of these were diagnostic devices and EUA test equipment. This sparked some of the amendments that expanded the FD&C Act.
In February of 2020, the HHS determined a coronavirus emergency, and subsequently declared the authorization of emergency use for COVID-19 diagnostics. In March 2020, circumstances were also justified for respiratory protective devices and alternative products used as medical devices. Since then, approximately 350 EUAs have been approved by the FDA, around 300 of which are for diagnostics where there are no FDA approved tests. A COVID-19 related FDA EUA list would include devices such as:
- Drug and biological therapeutic products
- Blood purification devices
- Continuous renal replacement therapy and hemodialysis devices
- In vitro diagnostics
- PPE and PPE decontamination systems
- Infusion pumps
- Ventilators and other respiratory assist devices
An unprecedented number of EUA requests have been fielded by the FDA. The agency is trying to allow needed devices without jeopardizing the safety of U.S. citizens.
While a medical device may normally have to jump through a multitude of regulatory hoops and be extensively tested through clinical trials, the development process is expedited for EUA devices. The COVID-19 pandemic called for immediate action, which was answered by providing a fast track for certain developers. It is the FDA’s job to judge which devices will help the population, and which ones could cause harm because they’ve been rushed. The FDA judges EUAs on their benefits, risks, and whether or not alternative solutions exist to a problem.
If you’re looking for FDA EUA guidance, in2being can help you navigate the requirements to develop your medical device. The quest for emergency use authorization approval can be difficult for developers who don’t have experience with it. At in2being, there’s a team of product designers, regulatory experts, and developers that work together to make the process as simple as possible. Our holistic approach to development ensures that everyone is on the same page and up to date. Whether you’re just starting out, or you’re stumped by the EUA process, reach out to one of our team members today.