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FDA Will Allow EUA Data To be Reused for Full Approval
(Thursday, June 9, 2022) In the last two and half years, FDA has approved hundreds of EUAs for various products for the diagnosis, management, and treatment of Covid-19. However, EUAs are temporary permits to sell products which ends when the emergency is declared to be over, i.e., the emergency declaration is withdrawn. An appropriate market approval (510k, PMA, NDA or BLA) must be obtained to continue selling the products post-EUA. FDA recently clarified that the data originally submitted in support of a given EUA could be reused to support an application for a 510k, PMA, NDA or BLA for that product so that the product stays available after the EUA is terminated. FDA’s requirements for the data needed to support the EUAs was quite stringent from the beginning, even for the first EUAs, and they evolved as more and more EUAs for similar products were authorized. Most of that data was similar to what would have been needed for a full market approval or clearance. The owners of the EUAs must evaluate what additional data, if any, may be needed for the full market approval and only collect that additional information. It would become obvious upon review to the applicants that the main differences between the EUA and a market approval application is the presentation of the supporting data and not the content. In most cases, the owners of the EUA products can simply reformat the information used for the EUA to support the subsequent 510k, NDA or BLA application. Most of the EUAs, by numbers, were granted to medical devices which would be eligible for 510k applications. The ability to use the EUA supporting data for 510k as well should make it easier to transition from the EUA to a full approval. 
AUTHOR
Dr. Mukesh Kumar Founder & CEO, FDAMap Email: mkumar@fdamap.com Linkedin: Mukesh Kumar, PhD, RAC Instagram: mukeshkumarrac Twitter: @FDA_MAP Youtube: MukeshKumarFDAMap |
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