FDA Emergency Use Authorization (EUA)
As a premier regulatory consulting firm, we specialize in assisting with the Emergency Use Authorization (EUA) process. The EUA is a provision established by the FDA to address urgent situations such as pandemics or other emergencies where immediate access to medical products is essential.
What is an EUA?
An EUA allows the FDA to authorize the use of an unapproved medical product or an unapproved use of an approved medical product during declared emergencies that pose a significant risk to public health, U.S. military forces, or national security. This authorization extends to a broad range of medical interventions, including drugs, devices, and diagnostic tests.
The EUA Process
The process of issuing an EUA involves five steps: Determination of an emergency, Declaration of an emergency, Review of the request for EUA by the FDA, Issuance of the EUA or denial of the request, and Termination of the EUA.
What is Pre-EUA?
A pre-EUA refers to a preparatory phase where the FDA collaborates with medical countermeasure developers to compile essential data and information. This process is conducted in advance of an emergency, facilitating prompt and comprehensive EUA requests when an emergency declaration is in effect.
Key Criteria and Operational Considerations for EUA
An EUA needs to fulfill four legal criteria to be evaluated. These criteria aim to guarantee that, even during emergencies, the public receives optimal, safest, and most suitable care possible. In addition to these criteria, an EUA can waive certain regulatory requirements to facilitate the use of unapproved products or approved products in unapproved situations as emergency medical countermeasures.
How to Submit an EUA?
Submitting an EUA request to the FDA involves a structured process aimed at providing comprehensive information about the medical product or treatment. The first step is to download the EUA template available on the FDA website, as it offers a standardized format for organizing the necessary data.
Our team of experts is here to guide you through this complex process, ensuring that your studies are conducted in a responsible and transparent manner. Contact us today at info@accelgroups.com to learn more about our FDA EUA services.
About Accel
Accel Groups is a dedicated team of seasoned professionals in regulatory, clinical and market access. We help medical device and IVD manufacturers with complete product life cycle solutions from preclinical, strategy, clinical evaluation and trial, regulatory submission, to post market surveillance. Our regional principals have a minimum of 10+ years’ experience in their specialty to enable us to provide the regional in-depth expertise but with global one-stop shop solutions. Ask us about our Start-up kits for start-up companies with key countries regulatory pathway.
