What are the current MDUFA user fees for a small business 510k submission?

Navigating the FDA's Small Business Program for Reduced 510(k) User Fees For any medical device company, particularly a startup or small business, managing the costs associated with regulatory submissions is a critical component of strategic planning. The Medical Device User Fee Amendments (MDUFA) authorize the U.S. Food and Drug Administration (FDA) to collect fees for the review of certain premarket submissions, including 510(k)s. While these fees support FDA's mission, they can represent a significant expense. To alleviate this burden, the FDA established the Small Business Determination (SBD) program, which allows qualifying businesses to pay significantly reduced user fees. Successfully qualifying for SBD status requires careful attention to detail, precise timing, and a thorough understanding of the eligibility criteria, which notably extend beyond the applicant company to include all parent, subsidiary, and affiliate entities. Obtaining SBD approval is not a formality; it is a formal review process that must be completed *before* the 510(k) is submitted. Failure to secure this approval in advance will result in the requirement to pay the full, standard user fee, a costly and often unbudgeted expense. This guide provides a detailed framework for navigating the SBD program, from understanding eligibility to preparing and timing the application for a successful outcome. ### Key Points * **Pre-Approval is Mandatory:** A company must have an approved SBD status from the FDA *before* submitting its 510(k) application. The reduced fee cannot be applied retroactively. * **Revenue is All-Encompassing:** Eligibility is based on the "gross receipts and sales" of the applicant company *and* all of its domestic and foreign parent companies, subsidiaries, and affiliates. This is a common point of error. * **Documentation is Evidence-Based:** The application hinges on providing official documentation, primarily the most recent U.S. federal income tax returns for all included business entities. * **Timing is Strategic:** SBD status is granted for the FDA's fiscal year (October 1 to September 30). Companies should apply at least 60-90 days before their planned 510(k) submission to allow for FDA review time. * **Official Sources are Essential:** MDUFA fee amounts and SBD qualification thresholds are adjusted annually. Sponsors must consult the official FDA website for the current fiscal year's information and forms. ### Understanding MDUFA Fees and the Small Business Determination (SBD) Program Under MDUFA, the FDA is authorized to collect user fees to expedite the review process for medical devices. These fees apply to various submission types, including 510(k)s, De Novo requests, and Premarket Applications (PMAs). The standard fee for a 510(k) can be a substantial investment for a small company. The SBD program is designed to support innovation by reducing this financial barrier. A "small business" is defined by the FDA as a business with gross receipts or sales of a specific amount or less for the most recent tax year. This threshold is subject to annual adjustment. To find the current user fees and SBD qualification thresholds, sponsors must consult the FDA's official website. **Important Note on Fees:** The FDA updates the MDUFA user fee schedule for each fiscal year. For the most current fee schedules, sponsors should always refer directly to the FDA's dedicated MDUFA user fees webpage at `https://www.fda.gov/industry/fda-user-fees`. This article does not state specific dollar amounts, as they are subject to change. ### Who Qualifies? Deconstructing the "Small Business" Eligibility Criteria The core of the SBD application is demonstrating that the business and its related entities fall below the annually defined revenue cap. This is more complex than simply looking at the applicant company's own revenue. #### The "Gross Receipts and Sales" Threshold The primary eligibility criterion is the total "gross receipts and sales" from the most recent tax year. This figure is generally taken from the top line of the U.S. federal income tax return (e.g., line 1a on Form 1120). It includes total sales, less returns and allowances, and any income from services, interest, dividends, rents, and royalties. #### The "All Affiliates" Rule: A Common Pitfall The most critical and often misunderstood aspect of the SBD application is the requirement to aggregate revenue from all affiliated entities. FDA's definition of an affiliate is broad and includes: * **Parent Company:** Any entity that owns more than 50% of the voting stock of the applicant. * **Subsidiary:** Any entity where more than 50% of the voting stock is owned by the applicant. * **Affiliates (or "Sister" Companies):** Two or more businesses where a third party (like a venture capital firm or another parent corporation) owns more than 50% of the voting stock of each. This calculation must include **all entities, both domestic and foreign**. For example, if a U.S.-based startup is majority-owned by a European parent company, the parent company's global revenue must be included in the calculation. This rule prevents large multinational corporations from creating small, separate U.S. entities solely to qualify for reduced fees. ### Step-by-Step Guide to the SBD Application Process The SBD application is a formal request that must be submitted to and approved by the Center for Devices and Radiological Health (CDRH) before it can be used. **1. Gather Required Documentation** The burden of proof is on the applicant. The primary document is the most recently completed U.S. federal income tax return for the applicant and every single parent, subsidiary, and affiliate. * **For U.S.-Based Entities:** Provide a complete, signed copy of the most recent federal income tax return. * **For Foreign Entities:** Since foreign entities do not file U.S. tax returns, their revenue must be certified. The company must provide a statement, signed by the company president or CEO, attesting to the foreign entity's gross receipts and sales for its most recent fiscal year, converted to U.S. dollars. * **Organizational Chart:** It is a best practice to include a clear organizational chart illustrating the relationship between the applicant and all parent, subsidiary, and affiliate companies. **2. Complete the MDUFA Small Business Qualification and Certification Form (FDA Form 3602)** This is the official application form. It requires the applicant to list all affiliates and certify that the total, aggregated gross receipts and sales do not exceed the current threshold. The form must be signed by a responsible company official. **3. Submit the Application Package to CDRH** The completed Form 3602 and all supporting documentation should be submitted to the CDRH MDUFA staff. The FDA's website provides the current email address for electronic submission, which is the preferred method. **4. Await FDA Decision and Receive SBD Number** The FDA states a review goal of 60 calendar days. If the application is complete and accurate, the FDA will issue an approval letter that includes a unique Small Business Decision Number. This number is valid for the remainder of the FDA's fiscal year (until September 30th) and **must be included on the cover letter of the 510(k) submission** to receive the reduced fee. ### Strategic Timeline: When to Apply for SBD Status Timing is crucial. An SBD approval received the day after a 510(k) is submitted is invalid for that submission. * **Understand the FDA Fiscal Year:** The SBD status is tied to the FDA fiscal year (October 1 – September 30). A new application must be submitted each fiscal year in which the company plans to make a submission requiring a user fee. * **Plan Backwards:** Identify the target 510(k) submission date. * **Factor in FDA Review Time:** Allow at least 60 days for the FDA to review the SBD application. * **Add a Buffer:** It is wise to add an additional 30-day buffer in case the FDA has questions or requires additional information. **Example Timeline:** * **Planned 510(k) Submission Date:** June 15 * **Submit SBD Application:** No later than March 15 (allows 90 days for review and buffer) * **Receive SBD Approval:** By May 15 * **Submit 510(k) with SBD Number:** On or after receiving the approval, by the June 15 target. ### Strategic Considerations and the Role of Q-Submission For a small business, every dollar counts. Successfully navigating the SBD program is a key part of an effective regulatory and financial strategy. It frees up capital that can be used for product development, clinical studies, or commercialization. While the Q-Submission program is not directly related to user fees, it aligns with the principle of proactive regulatory planning. Engaging with the FDA early via a Q-Submission can help a small business clarify testing requirements and de-risk its regulatory pathway. A well-executed Q-Sub can prevent costly delays or requests for additional data during the 510(k) review, further preserving a startup's limited resources. Integrating the SBD application timeline into the overall regulatory project plan, alongside activities like Q-Sub meetings and verification/validation testing, is a hallmark of a mature regulatory strategy. ### 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 documentation for both a 510(k) submission and an SBD application requires meticulous organization. Tools like Cruxi can help teams structure their regulatory documentation, track submission timelines, and ensure that critical documents, such as the SBD approval letter, are properly filed and included in the final 510(k) package. By centralizing regulatory information, these platforms can help small businesses manage complex processes efficiently and reduce the risk of administrative errors. *** *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.* --- *This answer was AI-assisted and reviewed for accuracy by Lo H. Khamis.*