Fang Consulting can advise clients
how to achieve their specific short term
and long term goals to ensure they align
with FDA requirements and guidance.
Per the Federal Food, Drug, and Cosmetic Act (FD&C Act), the US Food and Drug Administration allows for the emergency use of some medical products under certain circumstances. An Emergency Use Authorization (EUA) provides FDA with the authority to support emergency preparedness and response, including supporting the development and availability of unapproved or new medical products (drugs, biological products and medical devices) for use in emergency situations.
The Fang Consulting team supports EUA strategy and applications with a solid understanding of FDA requirements for COVID-19 related EUAs; we continue to keep abreast of changing requirements as they evolve throughout this time of emergency due to the current, global coronavirus pandemic. From providing strategic pathways for navigating various EUAs for COVID-19 products to developing commercial use plans for products available under EUAs, Fang Consulting can advise clients how to achieve their specific short term and long term goals to ensure they align with FDA requirements and guidance.
The FDA has stopped accepting new emergency use authorization applications. What does that mean for your go-to-market strategy? If you chose to submit an EUA application, it means reversing course and submitting a full 510(k) if you want your product to remain on market. If you opted to stay the course and submit the traditional 510(k), you are several strategic steps ahead of the EUA group – but you still have to navigate complex FDA requirements on your way to commercialization. Either way, Fang Consulting can help.
We’ve kept a weather eye on the ever-changing EUA requirements, helping companies develop strategic regulatory submission plans for COVID-19 test kits, personal protective equipment, and in-vitro diagnostic devices. And our consultants have been guiding clients through the 510(k), PMA and de novo submission processes through over forty years of combined experience, so we know how to determine which pathway is best for you.
Whether your choice was EUA or 510(k), our consultants can help you formulate the right strategy to bring your product to market – and keep it there. The EUA has been both bane and blessing to the medical device industry, offering a streamlined path to market for much-needed therapeutics, diagnostics, devices and more. The EUA requirements were often modified and sometimes fluid, opening the door to a host of questionable products that were rushed through development.
Over 1,400 previously unapproved medical products have been granted emergency use authorization by the FDA since March 2020 (source: FDA). Conversely, the agency has revoked 70 previously granted EUAs due to performance issues while recommending the recall of 225 more due to inaccurate labeling and/or unsubstantiated claims (source: FDA).
From the start, Fang Consulting was monitoring the authorizations and deconstructing the revocations to understand where manufacturers went wrong. As a result, our regulatory experts have a strong working knowledge of the EUA requirements for COVID-related products. We can tell when a go-to-market strategy is likely to fail, and when a product has a clear(er) path to post-EUA commercialization.
We know how to turn that EUA into a complete 510(k) and will help you identify the gaps and develop a plan to maintain your product’s market viability beyond the pandemic’s end. Whatever your need, Fang Consulting has the solution to effectively manage your EUA project from start to finish. Our consultants will put their expertise to work for you, finding the best regulatory strategy to achieve your specific post-EUA goals.