What is the 2024 FDA user fee for a 510k small business application?

## How to Qualify for the FDA’s Small Business 510(k) User Fee in 2024 For small medical device companies, managing the costs associated with a 510(k) submission is a critical part of strategic planning. A significant component of this budget is the user fee required by the FDA under the Medical Device User Fee Amendments (MDUFA). While the FDA sets a standard fee each fiscal year, it also offers a substantially reduced rate for businesses that qualify for its Small Business Determination (SBD) program. However, accessing this lower fee is not automatic and requires careful procedural planning. Successfully qualifying for the small business user fee hinges on a critical timing requirement: a company must apply for and receive an approved SBD from the FDA *before* submitting its 510(k) application. Failing to coordinate these two processes correctly can result in the company being liable for the full standard fee, a costly and unrecoverable error. Therefore, understanding the SBD application process and its relationship to the 510(k) submission timeline is essential for any small device manufacturer. ### Key Points * **SBD Approval is a Prerequisite:** A company must have an FDA-approved Small Business Determination for the current fiscal year *before* filing its 510(k) submission to be eligible for the reduced user fee. * **Timing is Everything:** The SBD application should be submitted well in advance of the planned 510(k) submission, as the FDA’s review and approval process for the SBD can take several weeks. * **No Retroactive Benefits:** If a company submits a 510(k) and pays the standard fee before its SBD is approved, the FDA will not issue a refund for the difference. The SBD status must be established first. * **Annual Renewal Required:** A Small Business Determination is typically valid for the U.S. government's fiscal year (October 1 to September 30). Companies must reapply each year to maintain their status. * **Eligibility is Defined by FDA:** Qualification as a small business is based on specific criteria set by the FDA, generally related to the company's gross receipts or sales. ### Understanding the FDA Small Business Determination (SBD) Program The SBD program is administered by the FDA's Center for Devices and Radiological Health (CDRH) to support smaller companies by reducing the financial barrier to market entry. Under the MDUFA framework, the fees collected from manufacturers are used to fund the FDA's device review activities. By offering a lower fee for small businesses, the FDA aims to encourage innovation from startups and other small entities. To qualify, a company and its affiliates must meet the FDA's definition of a small business, which is based on gross revenue from the most recent tax year. This threshold is updated periodically, and sponsors should always consult the FDA's official MDUFA guidance for the current fiscal year's requirements. The application itself is a formal request submitted to the FDA for review and is entirely separate from any marketing submission like a 510(k). ### Step-by-Step Process for Securing the Reduced Fee Navigating the process requires a structured approach. Manufacturers should treat the SBD application as a key regulatory milestone in their product development timeline. **Step 1: Confirm Eligibility** Before applying, a company must verify that it meets the FDA’s revenue criteria for the current fiscal year. This involves calculating the total gross receipts or sales for the business and all of its affiliates. **Step 2: Submit the SBD Application Form** The company must complete and submit the correct FDA form for Small Business Determination. This application requires providing financial information, typically from the previous year's federal income tax return, to substantiate the company's claim of small business status. **Step 3: Await FDA Review and Approval** Once submitted, the FDA will review the application. This review is not instantaneous and can take 60 days or more, so it is crucial to plan accordingly. If the application is complete and the company qualifies, the FDA will issue an official SBD approval letter. This letter is the evidence needed to claim the reduced fee. **Step 4: Pay the Reduced Fee and Submit the 510(k)** With the SBD approval letter in hand, the company can then proceed with its 510(k) submission. When paying the user fee, the sponsor selects the small business rate and must include a copy of the SBD approval letter in the 510(k) eSTAR submission as proof of eligibility. ### Common Timing Pitfalls and How to Avoid Them The most common error is a failure to align timelines, leading to the forfeiture of the reduced fee. * **Pitfall 1: Submitting the 510(k) Too Soon:** The most critical mistake is filing the 510(k) application before the SBD has been officially granted. The rule is absolute: no SBD approval at the time of 510(k) submission means the standard fee applies. * **Solution:** Establish a clear internal policy that the 510(k) cannot be filed until the SBD approval letter for the correct fiscal year is received. * **Pitfall 2: Underestimating SBD Review Time:** Teams often underestimate how long the FDA's administrative review of the SBD application will take. Assuming a quick turnaround can disrupt the entire submission schedule. * **Solution:** Submit the SBD application at least 2-3 months before the target 510(k) submission date to build a sufficient buffer. * **Pitfall 3: Forgetting Annual Renewal:** SBD status does not carry over from one fiscal year to the next. A company that qualified in 2023 is not automatically qualified for a 510(k) submitted in fiscal year 2024. * **Solution:** Mark calendars for the start of the new application period (typically in August) to renew the SBD status for the upcoming fiscal year (which begins October 1). ### Strategic Considerations and the Role of Q-Submission While the SBD process is administrative, it should be integrated into the broader regulatory strategy. The timeline for a 510(k) submission is often influenced by factors like testing completion and feedback from the FDA. Engaging the FDA through the Q-Submission program can help clarify testing requirements and solidify the submission timeline. By having a clearer picture of the 510(k) target submission date, a company can more effectively plan its SBD application. For example, if feedback from a Q-Submission indicates that additional testing is needed, pushing the 510(k) submission into the next fiscal year, the company will know to apply for SBD renewal accordingly. ### 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 submission timelines and documentation. By providing a structured environment to track key milestones, such as the SBD application deadline and the target 510(k) submission date, these platforms help teams avoid costly procedural errors and stay organized throughout the premarket process. 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.