What are the FDA user fees for a 510k submission in 2024?

Navigating FDA 510(k) User Fees: A Comprehensive Guide to Small Business Certification For medical device companies, preparing a 510(k) submission involves rigorous technical, clinical, and regulatory planning. However, an equally critical and often overlooked component is the financial and administrative process of managing the FDA user fee. Mandated by the Medical Device User Fee Amendments (MDUFA), this fee is a prerequisite for review, and failure to manage it correctly can result in significant delays. While the specific fee amounts change each fiscal year, the strategic process for determining eligibility for the reduced small business rate remains a constant challenge. Successfully navigating this process goes beyond simply checking a box; it requires a detailed understanding of the FDA's strict eligibility criteria, including the complex calculation of affiliate revenue, and adherence to firm administrative deadlines. An error in this process, such as a miscalculation of revenue or missing the certification deadline, can lead to a Refuse to Accept (RTA) decision, stopping a submission before the scientific review even begins. This guide provides a detailed, step-by-step framework for understanding MDUFA fees, determining small business eligibility, and executing the certification process to avoid common pitfalls. ### Key Points * **MDUFA Fees Are Mandatory:** Nearly every 510(k) premarket notification submitted to the FDA requires payment of a user fee, which is updated annually. Failure to pay the correct fee will result in the submission being placed on hold. * **Small Business Rate Offers Significant Savings:** Companies that qualify as a small business are eligible for a substantially reduced user fee. For the current fee schedule, sponsors must consult the official FDA website. * **Eligibility is Strict and All-Encompassing:** To qualify, a company, together with all of its domestic and foreign affiliates, must have gross receipts or sales below the FDA's designated threshold for the most recent tax year. * **Certification is a Prerequisite, Not a Co-requisite:** A company must apply for and receive an official Small Business Certification decision letter from the Center for Devices and Radiological Health (CDRH) *before* submitting the 510(k). This certification is valid for the fiscal year in which it is granted. * **Deadlines Are Inflexible:** The application for Small Business Certification must be submitted in time for FDA to review and approve it before the 510(k) is filed. Last-minute applications risk missing the window, forcing the payment of the standard fee. * **Incorrect Payment Guarantees a Delay:** Paying the wrong fee amount or failing to provide proof of payment is a common administrative reason for an RTA decision, which halts the review process until the discrepancy is resolved. ### 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. This funding is intended to provide the FDA with resources to conduct reviews in a more timely and predictable manner. The user fees are updated annually for each U.S. government fiscal year, which runs from October 1 to September 30. Because the fee amounts change every year, it is critical for sponsors to refer to the official FDA resources for the correct figures. **CRITICAL NOTE:** This article does not list specific dollar amounts for FDA user fees. For the most current fee schedules and official information, sponsors must consult the FDA's website directly at **https://www.fda.gov/industry/fda-user-fees**. ### Qualifying for the Small Business Rate: A Detailed Assessment The most important strategic consideration for many companies is determining eligibility for the small business rate. The FDA's definition is highly specific and requires a thorough analysis of a company's complete financial structure. The core requirement is that the company, including all of its affiliates, must have gross receipts or sales below a specific threshold (published annually on the FDA website). The most common point of failure in this assessment is an incorrect understanding of what constitutes an "affiliate." **What is an Affiliate?** The FDA considers affiliates to be any business entities that are controlled by or under common control with the applicant company. This includes: * **Parent Companies:** Any entity that owns or controls the applicant company. * **Subsidiaries:** Any entity owned or controlled by the applicant company. * **"Brother-Sister" Companies:** Companies that are controlled by the same parent entity as the applicant. * **Global Reach:** This calculation includes *all* domestic and foreign affiliates. A common mistake is for a U.S.-based startup to overlook the revenue of its large, international parent company. **Internal Checklist for Eligibility Assessment** Before starting the formal application process, regulatory and finance teams should collaborate to complete the following assessment: 1. **Identify All Business Entities:** Create a complete organizational chart that maps out the applicant company, its parent corporation(s), all subsidiaries, and any other commonly controlled businesses. 2. **Gather Financial Records:** Collect the most recently completed federal (or national equivalent) income tax returns for *every single entity* identified in the organizational chart. 3. **Calculate Total Gross Receipts/Sales:** Sum the total gross receipts or sales from all entities. Do not subtract returns or allowances. This combined figure is what the FDA will evaluate. 4. **Compare to the FDA Threshold:** Check the official FDA MDUFA user fee page for the current fiscal year's small business gross receipts/sales threshold. 5. **Make a Determination:** If the calculated total is below the FDA's threshold, the company is likely eligible to apply for certification. If it is over, the company must pay the standard fee. ### The Step-by-Step Process for CDRH Small Business Certification Obtaining small business certification is a formal administrative process that must be completed *before* the 510(k) submission is filed. #### Step 1: Plan Your Timeline The FDA can take up to 60 days to review a Small Business Certification request. Therefore, companies should submit their application **at least 2-3 months before their planned 510(k) submission date**. Submitting the certification request and the 510(k) simultaneously is not permitted and will result in delays. #### Step 2: Assemble the Required Documentation The application requires objective proof of your organization's gross receipts and sales. This typically includes: * The most recent U.S. federal income tax return for the applicant company. * The most recent U.S. federal (or foreign national) income tax returns for every affiliate, partner, and parent firm. * A cover letter explaining the submission and listing all included entities. * The official, completed FDA form for Small Business Certification (currently Form FDA 3602). All documents for foreign entities must be translated into English if not already in that language. #### Step 3: Complete and Submit the Application The application package, including the form and all supporting tax documents, should be sent to the CDRH MDUFA staff as directed in the FDA's guidance. Follow the instructions on the FDA website for the correct submission method (e.g., email or mail). #### Step 4: Receive and Safeguard the CDRH Decision Letter If the application is approved, CDRH will issue a Small Business Qualification Letter. This letter contains a unique Small Business Decision Number and is valid for the remainder of the fiscal year. This letter is the official proof of eligibility. #### Step 5: Pay the Correct Fee and Document It Once certified, the sponsor can proceed with paying the correct small business user fee. This payment must be made *before* filing the 510(k). The 510(k) submission itself (e.g., in the eSTAR or cover letter) must include: * A copy of the CDRH Small Business Qualification Letter. * Proof of payment of the user fee (e.g., a payment confirmation from the Device Facility User Fee website). ### Common Pitfalls and How to Avoid Them * **Pitfall 1: Misinterpreting "Affiliate."** * **How to Avoid:** Assume the broadest possible definition. Include every related business entity, foreign and domestic, in the initial calculation. When in doubt, it is better to include an entity in the calculation than to omit it and risk rejection. * **Pitfall 2: Missing the Certification Deadline.** * **How to Avoid:** Treat the Small Business Certification as a distinct project with its own timeline. Start the process at least three months before the target 510(k) submission date. * **Pitfall 3: Submitting an Incomplete Application.** * **How to Avoid:** Create an internal checklist to ensure all required tax returns for all affiliates are included and that all forms are filled out completely. Have both regulatory and finance personnel review the package before submission. * **Pitfall 4: Paying the Fee Incorrectly.** * **How to Avoid:** Do not submit the 510(k) until you have received both the Small Business Qualification Letter *and* confirmation that your payment has been successfully processed by the FDA. An incorrect payment is a straightforward administrative deficiency that will lead to an RTA hold. ### Strategic Considerations and Collaboration Successfully managing the MDUFA user fee process is not solely a regulatory affairs task. It requires close collaboration between the regulatory, finance, and executive teams. * **Regulatory & Finance Alignment:** These two teams must work together to gather the necessary financial documents and accurately calculate the combined gross sales. The regulatory team understands the FDA requirements, while the finance team has access to the official records. * **Budgeting and Financial Planning:** For startups and small companies, the difference between the standard and small business fee can be substantial. Accurately forecasting this cost is essential for budgeting, resource allocation, and conversations with investors. * **When to Contact FDA:** For questions about the Small Business Certification *process*, sponsors can contact the CDRH MDUFA staff directly. However, the Q-Submission program should be reserved for questions about regulatory strategy, clinical data, and testing requirements related to the device itself, not for administrative fee inquiries. ### 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 documents and deadlines associated with a 510(k) submission is a complex task. Regulatory information management platforms like Cruxi can help teams organize their submission files, track key deadlines (such as the small business certification application), and ensure that all required components, including proof of fee payment and the certification letter, are properly compiled before submission to the FDA. *** *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.*