FDA Small Business Determination (SBD) Certification Program Application

If your business qualifies for the FDA Small Business Designation (SBD) under the FDA SBD Certification Program, you could be eligible for significantly reduced FDA user fees for registrations, renewals, and submissions. This opportunity isn’t limited to U.S.-based companies—international organizations selling products in the U.S. are also eligible.

Why Apply for FDA SBD Certification?

• According to the FDA, a small business is defined as a company, including its affiliates, with gross receipts and sales under $100 million for the most recent tax year.
• The deadline to file your FDA Small Business Determination (SBD) Application and secure cost savings for 2025 FDA User Fees is October 1, 2024.
• Under the 2025 FDA User Fee Schedule, qualifying businesses can save over $18,000 on a single 510(k) submission compared to the standard fee.

No Cost, No Risk—Only Savings

• There’s no cost associated with submitting an FDA Small Business Determination Application.
• The savings potential is substantial, and the application process is straightforward when handled by experienced professionals.

Why Choose RQMIS for Your SBD Certification?

• Expert Guidance: Our team specializes in navigating FDA processes, ensuring your application is accurate and complete.
• Time-Saving Solutions: We know your time is valuable—let us handle the paperwork so you can focus on your business.
• Proven Success: We’ve helped numerous companies, both domestic and international, successfully achieve FDA Small Business Certification.

Don’t leave potential savings on the table. RQMIS can guide you every step of the way to ensure you qualify for FDA Small Business Designation and benefit from reduced MDUFA fees.

Your savings start with a simple step—reach out to RQMIS today and let us handle the details!

Maximize Your Savings with FDA Small Business Designation (SBD) Certification

Do you want to take advantage of significantly reduced fees for your FDA 510(k) submission? Our FDA consultants are here to guide you through the FDA Small Business Determination (SBD) application process.

Why Apply for FDA SBD Certification?

• Reduced FDA User Fees: Enjoy substantial savings on FDA submissions, including over $18,000 in savings on a single 510(k) submission under the 2025 fee schedule.
• Eligibility Assessment: Our FDA expert consultants will assess whether your business qualifies as a Small Business under FDA guidelines.
• Hassle-Free Process: We’ll handle the entire FDA SBD application process for you—saving you time, effort, and stress.\
• Global Eligibility: Both U.S.-based and international companies are eligible to apply if they sell products in the U.S.

Act Now—Don’t Miss Out on Savings!

The small business fees are significantly reduced this year, and there’s no cost to apply for SBD certification.

Let RQMIS simplify the process and secure your FDA Small Business Designation today!

FDA Small Business Determination ( FDA SBD certification) application must be done by October 1, 2024 to take advantage of have the SBD Certification!

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!