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, 2024.
Just as an example, under the 2025 User Fee schedule FDA small business Determination (SBD) can save in a quote, over $18,000 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!
Do you want to have the advantage of a reduced fee for your FDA 510K submission? Ask our FDA consultants for making the application for the FDA Small Business Determination (SBD)! Contact us today and an our FDA experts consultant will help determine if you qualify as a FDA Small Business Determination (FDA SBD), and make the FDA SBD application for you. The small business fees are highly reduced this year. Obtain your small business certification now!
Do you want to know which are the steps for the FDA small business determination (FDA SBD), and how to obtain better 510k submission fees?
1. Contact us to check if you qualify for the FDA small business application 2025
2. Once, we corroborate you can qualify for the small business, we will make all the work papers for you to submit your FDA small business application
3. We will make the application for the FDA small business certification request
4. When you have your small business certification, you can enjoy the small business fees!
Check the SBD certification fees below!