Beginning October 1, 2024, FDA will offer a transition period during which the Small Business Determination (SBD) can also be submitted electronically through the CDRH portal. Beginning November 1, 2024, SBD applications will only be accepted electronically through the CDRH portal. Applications not received electronically by FDA before November 1 will continue to be processed, but feedback on the status and outcome of applications will only be provided online through the portal. The Small Business Determination allows companies to significantly reduce FDA fees.
We are happy to answer any questions you may have about the Small Business Determination, user fees, or other regulatory issues related to the U.S. FDA.
FDA - Small Business Determination only possible electronically from November 2024
