Emergency Use Authorization. What it is and what it is NOT. Blog post by Managing Partner, Aidan Petrie
Emergency Use Authorization (EUA). What it is and what it is NOT.
by Aidan Petrie, Co-Founder + Managing Partner at NEMIC & Co-founder and Chief Innovation Officer, Emeritus at Ximedica
Over the last few months, we have learned about and then been a part of, at different levels, submissions under the FDA's EUA guidance. We have also been inundated with people and companies scrambling to get their concept into the market using an EUA.
The EUA is not a lowering of standards, it is a temporary measure to facilitate technologies that might be highly impactful to healthcare needs relating to COVID-19 and to the extraordinary times that we are living through. At the heart of it is a RISK to BENEFIT assessment, where the sponsor/entrepreneur describes how and why the risks associated with having a product brought to market are outweighed by the benefits. Acknowledging that some of the typical steps that the FDA requires through a normal process simply will take too long to complete. The FDA asks the sponsor to make an argument as to how the innovation addresses the emergency but will still examine safety and performance.
I will not go into detail here but there are many examples of where the criticality of the situation might cause that to happen.
The EUA is intended to give suitable protections to hospitals, physicians, manufacturers, sponsors, etc and has some 'liability' clauses that are worth noting while delivering care to patients at a time when the healthcare system is challenged.
Note... the EUA is temporary. We have advised strongly against over-committing from a business and inventory perspective on something that may no longer be viable to sell and which the supply side of the market may satisfy through normal channels over time.
Having said this, we have seen disruptive and novel solutions move through the process and enter that market that may have positive implications for healthcare in the future.
The New England Medical Innovation Center (NEMIC) is a not-for-profit Med Tech Venture Studio located in downtown Providence, Rhode Island. We support local, regional, and global Med Tech entrepreneurs and startups on their path to commercialization through education, advisory services, events, network, and a collaborative innovation center. Founded by Managing Partners, Aidan Petrie and Lydia Shin Schroter in late 2017, NEMIC has decades of combined medical device development and entrepreneurial experience. But what makes our work so impactful is our extensive network of local expert advisors and subject matter experts who simplify clinical access, regulatory (FDA) strategy/pathways, and ultimately facilitate connections between early stage startups and funding sources.
Navigating a regulated industry is hard. NEMIC can help.
At Ximedica, we transform bold ideas into life-changing innovations. Healthcare companies partner with Ximedica to strategize, design and develop medical devices and diagnostics because Ximedica is where the future is created. Your bold ideas. Our visionary team. Iconic results that change the world.