What are the MDUFA user fees for a 510k submission in fiscal year 2024?

## Understanding MDUFA User Fees for 510(k) Submissions For any medical device company planning a 510(k) premarket notification, understanding and correctly paying the associated Medical Device User Fee Amendments (MDUFA) fee is a critical, non-negotiable step. These fees, which are updated annually by the U.S. Food and Drug Administration (FDA), are essential for funding the agency's device review activities. An incorrect or missing payment is a common administrative error that can place a submission on hold, leading to preventable and costly delays. The MDUFA fee structure includes a standard rate and a significantly lower rate for businesses that qualify as a "small business." This qualification is not automatic and requires a proactive application process. Because the fee amounts change each fiscal year (beginning October 1), sponsors must verify the current rates on the official FDA website before making a payment to ensure their submission is accepted for review without issue. ### Key Points * **Annual Fee Updates:** MDUFA user fees are set annually and are effective for the FDA's fiscal year, which runs from October 1 to September 30. The applicable fee is based on the date the submission is received by the FDA. * **Two-Tiered Structure:** There are two main fee rates for a 510(k) submission: a standard fee and a reduced fee for qualified small businesses. * **Small Business Qualification is Proactive:** To be eligible for the lower rate, a company must meet the FDA's revenue-based definition of a small business and must apply for and receive a Small Business Determination (SBD) number from the FDA *before* submitting its 510(k). * **Payment is a Prerequisite for Review:** The FDA will not begin its substantive review of a 510(k) until the correct user fee has been paid and confirmed. Failure to pay the proper amount will result in a "user fee hold." * **The FDA Website is the Only Official Source:** Sponsors must always consult the FDA's official MDUFA user fee webpage for the current fiscal year's fee schedule. Do not rely on third-party sources or past fee amounts. ### Determining the Correct 510(k) User Fee The process of determining the correct fee involves two key steps: identifying the correct fee schedule for the current fiscal year and establishing whether the organization qualifies for the small business rate. #### Standard Fee vs. Small Business Fee Every year, the FDA publishes the fee schedule for various submission types, including the 510(k). Unless a company has successfully qualified as a small business, it is required to pay the standard fee. The small business fee offers a substantial reduction, designed to lessen the financial burden on smaller enterprises. However, eligibility is strictly defined. A company is generally considered a small business if it, along with its affiliates, reports gross receipts or sales below a specific threshold (e.g., $100 million) for its most recent tax year. This threshold is subject to change, and sponsors must verify the current criteria with the FDA. #### How to Qualify for the Small Business Rate Qualifying for the reduced fee is a formal process that must be completed well in advance of the planned 510(k) submission date. 1. **Meet the Criteria:** First, the company must confirm that its gross sales or receipts are below the FDA's published threshold for the current year. 2. **Submit an SBD Application:** The company must submit a Small Business Determination (SBD) request to the FDA. This application typically requires submitting the company’s federal income tax returns. 3. **Receive SBD Certification:** If the FDA confirms eligibility, it will issue an SBD certification letter with a unique SBD number. This certification is valid for that fiscal year. 4. **Include in 510(k) Submission:** When paying the reduced fee, the company must cite its valid SBD number in its 510(k) user fee cover sheet. It is critical to note that SBD status cannot be applied retroactively. If a company pays the standard fee and later receives its SBD certification, the FDA will not issue a refund for that submission. ### Strategic Planning and Considerations Integrating the MDUFA fee process into the overall regulatory strategy is essential for a smooth submission. * **Budgeting:** Regulatory teams should identify the correct fee early in the project planning phase to ensure it is included in the budget. * **Timeline:** For companies intending to use the small business rate, the SBD application process should be initiated several months before the target 510(k) submission date to account for FDA processing time. * **Verification:** Just before submission, the project lead should perform a final check on the FDA website to confirm the fee amount has not changed and that the correct payment is being made. For the most current FDA user fee information, sponsors should consult the FDA website at `https://www.fda.gov/industry/fda-user-fees`. ### 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 Navigating the administrative requirements of a 510(k) submission involves managing numerous documents, deadlines, and procedural steps. Tools like Cruxi can help regulatory teams organize their submission files, track project timelines, and create checklists to ensure that critical pre-submission tasks, such as verifying MDUFA fees and obtaining SBD certification, are completed on schedule. By centralizing documentation and project management, these tools can reduce the risk of administrative errors that lead to submission holds. *** *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.*