FDA Small Business Determination (SBD) Certification Program Application

If your business qualifies to make the application for the FDA Small Business Designation under the FDA guidelines for the FDA SBD certification program, you could be eligible for reduced FDA user fees for certain types of FDA registrations/renewals with the Agency - this FDA Small Business Application is not only to U.S. based organizations but also to international companies who sell products in the U.S.

Making the application to FDA small business certification (FDA SBD certification): According to the FDA, "a small business is defined as a business, including its affiliates, whose gross receipts and sales are less than $100 million for the most recent tax year". The deadline to file the application as an FDA Small Business Determination (SBD) certification and take advantage of the significant User Fee cost savings is October 1, 2023.

Just as an example, under the 2023 User Fee schedule FDA small business Determination (SBD) can save in a quote, over $9,500 on a 510(k) submission alone when compared to the standard fee. There is no cost associated with the FDA Small Business Determination Application, so you have nothing to lose! We know your time is precious and you probably have more concerning matters to attend to, so let us take care of the paperwork. RQMIS can help you with your FDA small business (FDA SBD) certification and you will be able to obtain the small business certification and enjoy the MDUFA fees. Do you know what the small business fees are? We can help you to obtain your small business qualification!