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

Navigating the FDA Small Business Determination Process for 510(k) User Fees For small medical device companies, securing a Small Business Determination (SBD) from the FDA is a critical step in managing the costs associated with a 510(k) premarket submission. While the reduced MDUFA (Medical Device User Fee Amendments) user fee offers significant financial relief, the process to qualify requires careful planning, precise documentation, and strategic timing. Obtaining SBD status is not automatic; it is a prerequisite that must be completed *before* a 510(k) can be submitted with the reduced fee. This article provides a comprehensive guide to the procedural and timing considerations that sponsors must navigate to secure an SBD. It breaks down the application timeline, common pitfalls in financial calculations, and best practices for coordinating the SBD approval with the final 510(k) submission to ensure a smooth, predictable, and financially optimized regulatory process. For the most current MDUFA user fee rates, including standard and small business fees, sponsors must always consult the official FDA website, as these amounts are updated annually. ### Key Points * **SBD is a Prerequisite, Not an Option:** A company must have an approved SBD *before* submitting its 510(k) to be eligible to pay the reduced user fee. The SBD approval letter is required as part of the submission process. * **Timing is Critical:** The FDA can take up to 60 days to review an SBD application. Sponsors should submit their SBD application at least 60-90 days before their target 510(k) submission date to avoid delays. * **"Gross Receipts or Sales" Includes All Affiliates:** When calculating eligibility, a company must consolidate the revenue of all domestic and foreign affiliates, partners, and parent organizations. This is a common point of error. * **Validity is Tied to the Fiscal Year:** An SBD is only valid for the federal fiscal year in which it is approved (October 1st to September 30th). If a 510(k) submission is delayed into a new fiscal year, a new SBD application is required. * **Documentation Must Be Precise:** The SBD application requires specific financial documentation, such as federal income tax returns. The unique SBD number assigned upon approval must be clearly referenced in the 510(k) cover letter and user fee payment forms. * **Fees Are Non-Refundable:** The MDUFA user fee is non-refundable. Ensuring SBD qualification *before* paying the fee is essential to avoid financial loss. For up-to-date fee information, sponsors should consult the FDA's official user fee webpage. ## Understanding the MDUFA Small Business Program 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. Recognizing the financial burden this can place on smaller innovators, the program includes a provision for significantly reduced fees for businesses that meet the FDA's definition of a "small business." To qualify, a business, along with all of its affiliates, must have "gross receipts or sales" of no more than $100 million for the most recent tax year. The key challenge for many companies lies not just in meeting the financial threshold but in correctly navigating the administrative process to prove their eligibility to the FDA in a timely manner. ## The Step-by-Step SBD Application Process Successfully obtaining an SBD requires a methodical approach. The process can be broken down into three primary stages: determining eligibility, assembling the application package, and submitting the request for FDA review. #### ### Step 1: Determine Eligibility by Calculating Gross Receipts This is the most critical step and the source of most application errors. The FDA’s definition of a small business is comprehensive and requires the consolidation of financials across an entire corporate structure. **What to Include in "Gross Receipts or Sales":** * **Consolidate All Affiliates:** The calculation must include the revenue of the applicant company, its parent company, all subsidiary companies, and any other affiliated businesses. * **Domestic and Foreign:** This includes all U.S.-based and foreign affiliates. A common mistake is omitting the revenue of an international parent company or sister entity. * **Definition of an Affiliate:** The FDA generally considers a business to be an affiliate if one business has the power to control the other, or if a third party controls both. This includes majority ownership, partnerships, and other forms of corporate control. * **Source of Truth:** The primary source for this calculation should be the most recent U.S. federal income tax return. For businesses that do not file a U.S. tax return (e.g., foreign entities), the FDA provides guidance on alternative documentation. Sponsors must meticulously map their corporate structure and sum the total revenue from all related entities before beginning the application. #### ### Step 2: Assemble the SBD Application Package Once eligibility is confirmed, the sponsor must gather the required documentation. The central component is the "MDUFA Small Business Qualification and Certification" form (Form FDA 3602). **Typical Components of the SBD Application:** 1. **Completed Form FDA 3602:** This form requires detailed information about the applicant and all affiliates, including names, addresses, and tax identification numbers. 2. **Supporting Financial Documents:** * **For U.S. Firms:** A complete copy of the most recent federal income tax return for the applicant and every affiliate. This must be the actual return filed with the IRS, not an internal financial statement. * **For Foreign Firms:** A complete copy of the most recent national government tax return. If a national tax return is not filed, the FDA may accept other certified financial documents, but sponsors in this situation should clarify requirements with the FDA. 3. **Organizational Chart:** It is a best practice to include a chart that clearly illustrates the relationship between the applicant and all its affiliates. This helps the FDA reviewer understand the corporate structure and verify the financial consolidation. #### ### Step 3: Submit the Application and Await Determination The SBD application is submitted to the FDA's Center for Devices and Radiological Health (CDRH). After submission, the FDA will conduct a review, which can take up to 60 days. If the application is complete and eligibility is verified, the FDA will issue an official SBD approval letter containing a unique SBD number. This number is valid for the remainder of the federal fiscal year. If the application is incomplete, the FDA will issue a rejection letter detailing the deficiencies, which must be corrected and resubmitted, restarting the review clock. ## Critical Timeline and Coordination Strategy Timing is everything. A poorly planned SBD application can delay a 510(k) submission by weeks or months. The goal is to have the approved SBD letter in hand before the 510(k) submission is finalized and ready to go. **Recommended Timeline:** 1. **90+ Days Before 510(k) Submission:** * Finalize the calculation of gross receipts and sales for all affiliates. * Gather all required tax returns and supporting financial documents. * Complete and internally review Form FDA 3602. 2. **60-90 Days Before 510(k) Submission:** * Submit the complete SBD application package to the FDA. * This buffer accounts for the FDA's 60-day review period and provides a cushion in case of any deficiencies. 3. **30 Days Before 510(k) Submission:** * Follow up with the FDA if a determination has not been received. * Upon receipt of the SBD approval letter, secure internal budget approval for the reduced MDUFA user fee payment. 4. **1-2 Weeks Before 510(k) Submission:** * Pay the reduced user fee through the FDA's Device Facility User Fee (DFUF) website. * Incorporate the SBD number and proof of payment (the Payment Confirmation Number, or PCN) into the 510(k) cover letter and eSTAR application. **Managing the Fiscal Year Crossover (October 1st):** The federal fiscal year turnover is a critical planning milestone. An SBD granted in August is only valid until September 30th of that same year. * **Scenario:** A company receives its SBD in August but experiences a slight delay, pushing its 510(k) submission to October. * **Action Required:** The original SBD is now expired. The company must submit a *new* SBD application for the new fiscal year, using the most recent tax year's data, and wait for a new SBD approval before it can submit its 510(k). This can cause significant delays if not anticipated. ## Strategic Considerations and the Role of Q-Submission While the SBD process is purely administrative and financial, it is inextricably linked to the technical and regulatory strategy of the 510(k) submission itself. The MDUFA user fee is non-refundable, representing a significant financial commitment. Engaging the FDA through the Q-Submission program *before* finalizing the 510(k) can be a valuable risk-mitigation strategy. By obtaining FDA feedback on key aspects of the submission—such as the choice of predicate, testing plan, or clinical data requirements—a sponsor can increase the predictability of the 510(k) review. This confidence makes the subsequent payment of the MDUFA fee a more calculated investment. Aligning the Q-Sub feedback timeline with the SBD application timeline ensures that by the time the user fee is due, the company has de-risked both its financial qualification and its technical submission 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 Navigating the multitude of documents, deadlines, and procedural requirements for both an SBD application and a 510(k) submission can be complex. Regulatory intelligence platforms like Cruxi can help teams organize their submission strategy, manage timelines, and structure documentation. By centralizing regulatory information and tracking key milestones—from SBD application submission to final 510(k) filing—these tools empower teams to maintain control and predictability throughout the regulatory 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.* --- *This answer was AI-assisted and reviewed for accuracy by Lo H. Khamis.*