What is an EUA?
In the United States, Emergency Use Authorizations (EUAs) may be granted by the Food and Drug Administration (FDA) for certain drugs or medical devices to help strengthen the nation against health threats such as infectious diseases like COVID-19. EUA’s temporarily authorize previously unapproved medical products, or unapproved uses of approved medical products, to be used to help prevent, diagnose, or treat diseases or conditions caused by the public health emergency.
With an EUA, a device manufacturer is granted temporary market authorization during a public health threat. However, once the public health crisis is no longer at a critical level, FDA may expire the EUA and market authorization will be revoked. Companies that intends to keep their medical device on the market after the EUA has expired will need a 510(k) pre-market notification application to be granted for their product.
Looking to Gain Market Access Through The EUA Pathway?
Our team of regulatory experts specialize in working collaboratively with our clients to achieve their unique short-term and long-term goals in the medical device industry.
Contact us today for a free consultation to discuss your project and if your product qualifies for the EUA pathway. If it doesn’t qualify, our team will go over alternative pathway options to achieve your business goals.
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EUA Preparation and Submission Services
Our team of regulatory experts will review your medical device and intended use to determine if an EUA is appropriate and applicable to your product. If so, we will work collaboratively with your team to review your product’s information, conduct a gap analysis on your available test data (analytical and/or clinical, etc.), and develop a customized submission strategy to efficiently gain authorization for your product through this pathway. If your device does not meet the EUA criteria, our team will work with you to achieve market authorization through an appropriate pathway.
Post EUA Submission Support: 510(k)
If your device is, or was previously, approved for the US market through the EUA pathway, it will need to be submitted and accepted through the 510(k) pathway (or other applicable regulatory approval pathway) to secure long-term market approval. Contact our team today to discuss your how we can utilize your current product and testing data from your EUA submission to expedite the 510(k) process and achieve long term market approval for your products.
