During a public health emergency, the FDA can authorize new medical technologies that have not been approved, and other products that have been approved, but for different indications, through an abbreviated review process called Emergency Use Authorization (EUA) when FDA concludes that the "possible" benefits of using these products during a health emergency outweigh the anticipated risks. The EUA provides temporary marketing authorization during a public health emergency and does not replace the 510(k), PMA or other routine processes for seeking U.S. marketing clearance and/or approval.
Many medtech companies are working with FDA to secure EUAs for their products to help address the COVID-19 pandemic. But EUAs are not necessarily limited to ventilators and lab tests. FDA is also considering other innovative diagnostic and therapeutic technologies that may be used to help mitigate the broader impact of the COVID-19 pandemic on the public health.
- Should you consider an EUA request for your product?
- What is the process for seeking emergency authorization?
- And how can EUA review help you better understand the U.S. market and accelerate your pathway to approval once the emergency has ended?
An EUA can offer insight into the "new normal" healthcare market that will emerge post-pandemic.
Join Ed Dougherty and Peter Raymond for a discussion of an EUA on which they worked together. Hear their insights on navigating the regulatory process with FDA, steps for implementing quality by design in crisis mode, strategies for sourcing, manufacturing, and distribution in spite of a broken supply chain, and how to push across the finish line, to ensure that these products get to clinicians and their patients when they need them.