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

# Navigating FDA 510(k) User Fees: A Comprehensive Guide to Avoiding RTA Holds Successfully navigating the FDA 510(k) submission process requires meticulous attention to both scientific and administrative details. Among the most critical administrative hurdles is the correct payment and documentation of the Medical Device User Fee Amendments (MDUFA) user fee. An error in this step is a common and entirely avoidable reason for a 510(k) to be placed on a Refuse to Accept (RTA) hold, causing significant delays. While the specific user fee amount changes each fiscal year, the process for managing it remains consistent. Sponsors must not only identify the correct fee but also manage prerequisite qualifications, adhere to strict timelines, and provide precise documentation within their submission package. This guide provides a detailed framework for managing the 510(k) user fee process, from determining small business eligibility to confirming documentation within the final submission, to help ensure a smooth acceptance review. ## Key Points * **Official Source is Paramount:** The FDA updates MDUFA user fees annually for each fiscal year, which begins on October 1st. The official FDA website is the only reliable source for the current fee schedule. This article does not state specific fee amounts. * **Small Business Status is a Prerequisite:** To qualify for a reduced fee, a company must first apply for and receive an approved Small Business Determination (SBD) from CDRH. This approval must be secured *before* submitting the 510(k). * **Timing is Critical:** Submitting a 510(k) with a small business fee before receiving the official SBD approval letter, or paying a prior fiscal year's fee after October 1st, will likely result in an RTA hold. * **Documentation is Mandatory:** Every 510(k) submission must include a completed User Fee Cover Sheet (Form FDA 3601) and proof of payment to verify that the correct fee has been paid. * **Annual Renewal Required:** A Small Business Determination is only valid for the fiscal year in which it is approved. Sponsors must reapply each year to maintain their status for future submissions. ## Understanding the MDUFA User Fee Framework Under the authority of the Medical Device User Fee Amendments (MDUFA), the FDA is authorized to collect fees from medical device companies to fund the review of premarket submissions, including 510(k)s. This framework is intended to provide the FDA with resources to conduct reviews in a timely and predictable manner. The fee amounts are set annually and published on the FDA's website. There are two primary fee tiers for a 510(k): 1. **Standard Fee:** The full fee applicable to most submissions. 2. **Small Business Fee:** A significantly reduced fee for sponsors who meet the FDA's definition of a small business and have successfully completed the SBD qualification process. Failure to pay the correct amount for the submission date is a common criterion for an RTA hold, as outlined in FDA's guidance on its RTA policy. This makes managing the fee payment a critical component of submission project management. ## A Step-by-Step Process for Managing 510(k) User Fee Payment To avoid common pitfalls, sponsors should implement a robust internal process. The following steps provide a reliable framework for managing the user fee from start to finish. ### Step 1: Determine Eligibility for Small Business Status The first step is to determine if the company qualifies as a small business. The FDA's definition is based on the gross receipts or sales of the company and its affiliates. This is an optional but highly valuable step for eligible companies. * **Action:** Review the current criteria for small business qualification on the FDA's MDUFA website. The criteria are specific and require careful assessment of financial records. * **Best Practice:** Perform this assessment early in the product development lifecycle, well before the planned 510(k) submission. ### Step 2: (If Applicable) Apply for and Secure Small Business Determination (SBD) If a company is eligible, it must formally apply to the FDA for SBD status. * **Action:** Complete and submit the "CDRH Small Business Certification Request" (Form FDA 3602). This form requires providing financial information for verification. * **Critical Timing:** The SBD application should be submitted at least 6-8 weeks before the planned 510(k) submission. The FDA review of the SBD application can take several weeks, and the 510(k) cannot be submitted with the reduced fee until the official SBD approval letter is received. * **Outcome:** If approved, the FDA will issue an SBD approval letter that includes a unique SBD number. This number is valid for the current fiscal year only and is required for the User Fee Cover Sheet. ### Step 3: Identify the Correct User Fee Amount and Make Payment Once SBD status is confirmed (or if the company is paying the standard fee), the next step is to identify the precise fee and make the payment. * **Action:** Visit the official FDA website to find the current MDUFA user fee schedule. Identify the correct fee based on the submission type (Premarket Notification: 510(k)), business size (Standard or Small Business), and the fiscal year in which the 510(k) will be submitted. * **Best Practice:** For the most current FDA user fee information, sponsors should consult the FDA website at **https://www.fda.gov/industry/fda-user-fees**. * **Payment:** Follow the instructions on the FDA website to make the payment. Save the payment confirmation receipt, as this is essential for documentation. ### Step 4: Complete and Include the User Fee Cover Sheet The final administrative step is to document the payment within the 510(k) submission itself. * **Action:** Complete the "Medical Device User Fee Cover Sheet" (Form FDA 3601). This form requires the sponsor’s name, payment identification number, the amount paid, and the SBD number if a reduced fee was paid. * **Documentation:** This completed cover sheet must be included in the 510(k) submission package. For eCopy or eSTAR submissions, it should be placed in the appropriate section as per FDA guidance. * **Best Practice:** Make the User Fee Cover Sheet a mandatory item on the final internal submission checklist. A designated team member should verify that the fee amount, SBD number, and payment confirmation details on the form are correct and match the supporting documentation. ## Common Pitfalls and How to Avoid Them Even with a process, errors can occur. Understanding common scenarios can help sponsors avoid them. ### Scenario 1: The Fiscal Year Mismatch * **The Pitfall:** A company prepares its 510(k) submission in late September and has the correct user fee for the current fiscal year. However, due to internal delays, the submission is not sent to the FDA until October 3rd. The company fails to realize that the fiscal year changed on October 1st, and a new, higher fee schedule is now in effect. * **The Result:** The submission is placed on an RTA hold for underpayment. * **Prevention:** Implement a hard checklist item: "If submitting within two weeks of October 1st, re-verify the user fee amount on the FDA website on the day of submission." ### Scenario 2: The Presumptive SBD Submission * **The Pitfall:** A startup is confident it qualifies as a small business. It submits its SBD application on Monday and, assuming it will be approved, submits its 510(k) on Friday of the same week with the reduced fee payment. * **The Result:** The 510(k) is put on an RTA hold because, at the time of its receipt, the FDA had not yet approved the company's SBD status. The sponsor was not yet officially qualified to pay the reduced fee. * **Prevention:** Treat the SBD approval as a non-negotiable prerequisite. The project timeline must account for the SBD review period. Do not pay the fee or compile the final submission package until the official SBD approval letter is in hand. ## Strategic Considerations and the Role of Q-Submission While user fee management is an administrative task, it is intrinsically linked to a company's overall regulatory strategy. Paying a substantial user fee for a 510(k) is a significant investment. Before reaching this stage, sponsors should have high confidence in their chosen regulatory pathway and the sufficiency of their testing data. This is where the Q-Submission program becomes invaluable. Engaging with the FDA through a Pre-Submission (Pre-Sub) allows sponsors to gain alignment on key strategic questions, such as: * Is the proposed predicate appropriate? * Is the proposed testing plan (bench, animal, clinical) adequate to demonstrate substantial equivalence? * Is a 510(k) the correct pathway, or is the device a candidate for De Novo? Clarifying these points through a Q-Submission de-risks the entire project. It ensures that the resources invested in the 510(k)—including the non-refundable user fee—are directed toward a submission with a clear and well-vetted regulatory logic. ## 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 Tools like Cruxi can help regulatory teams create standardized submission templates and internal checklists. By incorporating mandatory checkpoints such as "Verify SBD Approval Letter is on File" and "Confirm Current Fiscal Year User Fee on FDA.gov," teams can build repeatable, auditable processes that minimize the risk of costly administrative errors, such as those that lead to RTA 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.* --- *This answer was AI-assisted and reviewed for accuracy by Lo H. Khamis.*