These times require swift and efficient action to deliver medical device products to help save lives. If you have a product that can positively impact the health of those at risk and are trying to get your product through the FDA, you may want to think about pursuing an Emergency Use Authorization of Medical Products and Related Authorities (EUA). If you believe this path is a viable one for your product, bear in mind the following about the EUA:
- Your product must address the serious or life-threatening disease or condition for which the EUA was issued.
- You should be ready to demonstrate that your product “may be effective” in preventing diagnosing or treating serious or life-threatening diseases or conditions identified by the EUA.
- You should provide evidence for the FDA to determine that the known and potential benefits of the product, when used to diagnose, prevent, or treat the identified disease or condition, outweigh the known and potential risks of the product.
A short review of the FDA guidance for Emergency Use Authorization of Medical Products and Related Authorities will tell you that this is just the beginning of what you need to consider. Other considerations include how to request an EUA, FDA information and data expectations, navigating issues around an EUA for new indications of use for a cleared or approved product or a new device the FDA has not reviewed, and more.
In short, your EUA pathway is a submission. If you are not comfortable managing this kind of submission to the FDA, particularly in these times when urgency to cross a goal line tends to generate mistakes, then contact us; we can help you.