How much are the FDA 510k user fees for a small business?

## How to Qualify for Reduced FDA 510(k) User Fees as a Small Business For medical device companies, particularly startups and small businesses, managing the costs associated with regulatory submissions is a critical planning component. The FDA's Medical Device User Fee Amendments (MDUFA) establish fees for various premarket submissions, including the 510(k). While a standard fee applies to most submissions, the FDA offers a significantly reduced user fee for organizations that qualify as a "small business." Accessing this lower fee, however, requires a separate, proactive application process that must be completed *before* the 510(k) is submitted. The timing of this certification is crucial; if a company submits its 510(k) before receiving its small business designation, it is generally required to pay the full standard fee. This article explains the key procedural considerations for a company seeking to qualify for the small business user fee for a 510(k) submission and highlights why the timing of this certification is so critical for financial planning. ### Key Points * **Process, Not Price:** This article explains the *process* for qualifying as a small business. Specific user fee amounts change annually and are not listed here. For the most current fee schedules, sponsors must consult the official FDA website. * **Separate Application Required:** Qualifying for the reduced fee is not automatic. Sponsors must submit a separate Small Business Determination (SBD) application to the FDA and receive approval. * **Timing is Critical:** The SBD application must be reviewed and approved by the FDA *before* the 510(k) submission is filed. Submitting a 510(k) without a valid SBD approval will result in the sponsor being billed for the standard, full-price user fee. * **Annual Qualification:** A small business designation is typically valid for the FDA's fiscal year (October 1 to September 30) in which it is approved. Sponsors may need to reapply for subsequent years. * **Official Source is Key:** The FDA website is the only official source for eligibility criteria, application forms, and current user fee amounts. ### Understanding the Small Business Determination (SBD) Program The FDA’s Small Business Determination (SBD) Program allows smaller companies to pay significantly lower user fees for certain medical device submissions. This program was established under the Medical Device User Fee Amendments (MDUFA) to help reduce the financial burden on smaller enterprises bringing innovative devices to market. Eligibility for the program is based on a company's gross receipts or sales, including those of its affiliates. Because these financial thresholds and the user fee amounts are updated annually, it is essential for sponsors to refer to the FDA's official resources for the current requirements. The key takeaway is that this is a formal certification process—not just a box to check on a form—and requires careful planning to execute correctly. ### The Critical Steps for Qualification Successfully obtaining small business status for a 510(k) submission involves a clear, linear process that must be managed well in advance of the planned submission date. **1. Verify Eligibility** Before starting the application, a company must confirm it meets the FDA's definition of a small business for the current fiscal year. This involves calculating the company's gross sales and receipts, including all affiliates, and comparing them to the threshold published on the FDA's website. **2. Complete and Submit the SBD Application** The next step is to complete the official SBD application form. This form requires detailed financial information and must be certified by a responsible company official. The completed application is submitted directly to the FDA's Center for Devices and Radiological Health (CDRH) MDUFA staff, not as part of the 510(k) submission itself. **3. Await FDA Approval** After submission, the FDA will review the application. This review can take several weeks. The sponsor must wait until it receives an official approval letter from the FDA confirming its small business status for the current fiscal year. This approval letter will contain a unique Small Business Determination (SBD) number. **4. Submit the 510(k) with Proof of Status** Once the SBD approval is granted, the sponsor can proceed with its 510(k) submission. The 510(k) user fee form should indicate payment of the small business fee, and the submission's cover letter should clearly reference the approved SBD number. It is standard practice to include a copy of the SBD approval letter within the administrative section of the 510(k) eCopy. ### Strategic Considerations and the Role of Q-Submission Integrating the SBD application into the overall regulatory strategy and timeline is essential. Companies planning a 510(k) submission should identify the SBD application as a critical-path dependency several months in advance. Delaying this administrative step can lead to significant, unplanned costs if the standard fee must be paid. While a Q-Submission (Q-Sub) is used to gain FDA feedback on the scientific and technical aspects of a planned submission, it serves as a reminder of the importance of early and comprehensive planning. Just as a Q-Sub helps de-risk the technical review of a device, proper administrative planning—including the timely filing of an SBD application—de-risks the financial and procedural aspects of the submission process. Effective project management treats both technical readiness and administrative compliance with equal importance. ### Key FDA References - FDA Guidance: general 510(k) Program guidance on evaluating substantial equivalence. - FDA Guidance: Q-Submission Program – process for requesting feedback and meetings for medical device submissions. - 21 CFR Part 807, Subpart E – Premarket Notification Procedures (overall framework for 510(k) submissions). ## How tools like Cruxi can help Tools like Cruxi can help medical device manufacturers manage their regulatory project timelines, organize submission documents, and track key deadlines. By centralizing all regulatory activities, including administrative prerequisites like user fee applications, teams can ensure that critical steps are not missed in the lead-up to a major submission. This article is for general educational purposes only and is not legal, medical, or regulatory advice. For device-specific questions, sponsors should consult qualified experts and consider engaging FDA via the Q-Submission program.