What is the FDA MDUFA user fee for a 510k submission in fiscal year 2024?

## Understanding FDA 510(k) MDUFA User Fees for Fiscal Year 2024 Medical device sponsors preparing a 510(k) premarket notification must account for the Medical Device User Fee Amendments (MDUFA) user fee. This fee is a mandatory component of the submission process, and the FDA will not accept a 510(k) for review until the correct payment has been made. The FDA updates these fees annually for each fiscal year, which runs from October 1 to September 30. For fiscal year 2024 (FY2024), the FDA has published a specific fee schedule for all submission types, including 510(k)s. A key feature of this schedule is a two-tiered system: a standard fee and a significantly reduced fee for organizations that qualify as a "small business." To be eligible for the lower rate, a company must apply for and receive a Small Business Determination (SBD) from the FDA *before* submitting its 510(k). Understanding this process is a critical budgetary and planning step for any device manufacturer. ### Key Points * **Fees are Updated Annually:** The MDUFA user fees for 510(k) submissions change each fiscal year. Sponsors must always verify the current fee amount for the year in which they plan to submit, such as FY2024, by checking the official FDA website. * **Two-Tier Fee Structure:** The FDA maintains a standard fee and a substantially lower fee for businesses that meet the agency's criteria for a small business. * **Small Business Status is Not Automatic:** A company must formally apply to the FDA and receive a Small Business Determination (SBD) qualification to be eligible for the reduced fee. This requires submitting specific financial documentation. * **Timing is Critical:** The SBD application must be approved *before* the 510(k) submission is filed. The review process for an SBD application can take several weeks, so sponsors should apply well in advance of their target 510(k) submission date. * **Payment is a Prerequisite for Review:** The FDA's acceptance review process for a 510(k) includes confirming that the correct user fee has been paid. Failure to pay the correct amount can result in a refusal to accept (RTA) decision, delaying the start of the substantive review. ### Understanding MDUFA and 510(k) User Fees The Medical Device User Fee Amendments (MDUFA) authorize the FDA to collect fees from medical device companies to help fund the review of premarket submissions, including 510(k)s, De Novos, and PMAs. This program is designed to provide the FDA with resources to conduct reviews in a timely and predictable manner. Under the regulations for premarket notifications, outlined generally in 21 CFR Part 807, Subpart E, a user fee is required for most submissions. Each year, the FDA publishes its MDUFA fee schedule for the upcoming fiscal year. For a company planning a 510(k) submission in 2024, it is essential to consult the official FY2024 MDUFA fee guidance on the FDA's website to determine the exact standard and small business fee amounts. ### The Small Business Determination (SBD) Program The SBD program offers significant financial relief to smaller companies, making the regulatory process more accessible. However, eligibility is strictly defined and requires a formal application process. #### What FDA Considers a "Small Business" According to FDA guidance, a small business is generally defined as a company, including its affiliates, with gross receipts or sales of no more than $100 million for the most recent tax year. The specific criteria and required documentation are detailed in the FDA's SBD program guidance documents. #### The SBD Application Process 1. **Gather Documentation:** The primary evidence required is the company's most recent U.S. federal income tax return. For businesses that do not file a U.S. tax return, the FDA provides alternative documentation requirements. 2. **Complete the Application Form:** Sponsors must fill out Form FDA 3602, the "MDUFA Small Business Qualification and Certification" application. This form requires detailed information about the business and its affiliates. 3. **Submit to FDA:** The completed form and supporting tax documents are submitted to the FDA's Center for Devices and Radiological Health (CDRH) for review. 4. **Receive Determination Letter:** If the application is approved, the FDA will issue an SBD qualification letter that includes a unique Small Business Determination number. This number is valid for the fiscal year in which it is issued. This number must be included on the 510(k) User Fee Cover Sheet (Form FDA 3601) at the time of submission to qualify for the reduced fee. Sponsors should plan to apply for SBD status at least 60 days before their intended 510(k) submission date to account for FDA review time and avoid any last-minute delays. ### Strategic Considerations and the Role of Q-Submission Integrating the MDUFA fee and SBD application into the overall regulatory strategy is crucial. While a Q-Submission (or Pre-Submission) does not have a user fee, the feedback gained from this process is invaluable. By engaging with the FDA early, sponsors can de-risk their regulatory plan and confirm their testing strategy. This ensures that the subsequent 510(k) submission is robust, complete, and has a higher chance of success, preventing the MDUFA fee from being spent on a submission that is ultimately found to be deficient. Budgeting for the correct MDUFA fee is a tactical step, but ensuring the submission itself is sound is the strategic goal that a Q-Submission can support. ### 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 Managing the numerous administrative and technical requirements of a 510(k) submission is complex. A dedicated platform can help teams track critical deadlines, manage documentation, and organize submission elements. By structuring the submission process, tools like Cruxi help ensure that key prerequisites, such as applying for SBD status and budgeting for the correct MDUFA user fee, are addressed early, preventing costly delays and keeping the project on track. 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.