The FDA Small Business Decision Qualification is a game-changer for small businesses in the medical device, pharmaceutical, and nutraceutical industries by reducing Medical Device User Fees. This Qualification Designation offers a range of cost saving benefits when submitting applications to the FDA for your product to go to market.
Achieving FDA approval is a mark of quality and safety that can significantly boost market confidence in your products. The FDA Small Business Decision Qualification helps small companies achieve this milestone more efficiently, enhancing your reputation and credibility. This improved market confidence can lead to increased sales, partnerships, and investment opportunities.
The advantage of the FDA Small Business Decision Qualification helps with the reduction in user fees when submitting your premarket submissions. Small businesses (and its affiliates) with gross receipts and sales of $100 million or less for the most recent tax year are eligible for these substantial fee discounts, making it more affordable for you to bring new products to market.
FDA User Fees follow the FDA Fiscal Year 2025 (October 1, 2024 thru September 30, 2025)
Other fees for Fiscal Year 2024 (October 1, 2023, through September 30, 2024) are:
| Application Type | Standard Fee | Small Business Fee† |
|---|---|---|
| 510(k)‡ | $21,760 | $5,440 |
| 513(g) | $6,528 | $3,264 |
| PMA, PDP, PMR, BLA | $483,560 | $120,890 |
| De Novo Classification Request | $145,068 | $36,267 |
| Panel-track Supplement | $386,848 | $96,712 |
| 180-Day Supplement | $72,534 | $18,134 |
| Real-Time Supplement | $33,849 | $8,462 |
| BLA Efficacy Supplement | $483,560 | $120,890 |
| 30-Day Notice | $7,737 | $3,869 |
| Annual Fee for Periodic Reporting on a Class III device (PMAs,PDPs, and PMRs) | $16,925 | $4,231 |
† Small Business Fee: For businesses certified by the Center for Devices and Radiological Health (CDRH) as a small business.
‡ 510(k) Fees: All types of 510(k)s (Traditional, Abbreviated, and Special) are subject to the user fee. However, there is no user fee for 510(k)s submitted to the FDA on behalf of an FDA-accredited third-party reviewer.
The FDA Small Business Decision is a vital initiative by reducing fees helps small companies overcome challenges and achieve their goals. RQMIS is here to help you achieve the FDA Small Business Qualification Approval especially since the FDA Small Business Decision Qualification must be renewed yearly. Contact us today to learn how we can support your business in leveraging the FDA Small Business Decision for growth and innovation.