What are the FDA user fees for De Novo submission in 2024?

## Navigating FDA De Novo User Fees and Small Business Qualification For medical device manufacturers developing a novel, low-to-moderate risk product with no existing predicate device, the De Novo Classification Request is a primary pathway to the U.S. market. This pathway, often used for innovative technologies like AI-driven diagnostic software or unique wearable biosensors, requires careful strategic planning. A critical component of this planning is budgeting for the applicable Medical Device User Fee Amendments (MDUFA) fees, which the FDA updates annually. Understanding these fees, and the process for potentially qualifying for a reduced rate as a small business, is essential for a successful submission strategy. Sponsors must consult the official FDA source for the current fee schedule, as these figures change each fiscal year. Furthermore, eligibility for a small business fee reduction is not automatic and requires a separate, timely application to the FDA. ### Key Points * **Official Source is Paramount:** The FDA’s official website is the only reliable source for the current MDUFA user fee schedule. Sponsors should never rely on third-party sites or outdated information for budgeting. * **Fees are Updated Annually:** MDUFA fees are updated for each U.S. government fiscal year, which begins on October 1st. A fee for a submission in September may differ from one in October of the same calendar year. * **Small Business Reduction:** The FDA offers a significant fee reduction for De Novo submissions from organizations that qualify as a "small business." * **Separate Application Required:** To receive the reduced fee, a company must first submit a Small Business Determination (SBD) request to the FDA and receive approval. This is a separate process from the De Novo submission itself. * **Timing is Critical:** The SBD application must be approved *before* the De Novo submission is filed to qualify for the reduced fee. Sponsors should initiate this process well in advance of their target submission date. ### Understanding MDUFA and De Novo 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 De Novo requests. This program provides the FDA with resources to hire reviewers, manage the review process, and meet performance goals for decision timelines. Because these fees are subject to change each year based on inflation and other factors, it is a critical regulatory operations task to verify the correct amount before submission. Submitting an application with an incorrect fee payment can lead to a refusal-to-accept (RTA) hold, delaying the start of the substantive review. For the most current and official fee schedules, sponsors must consult the FDA's dedicated user fee webpage. The FDA typically posts the upcoming fiscal year's fees in the late summer. **For current FDA user fee information, sponsors should consult the FDA website at https://www.fda.gov/industry/fda-user-fees.** ### Qualifying for the Small Business Fee Reduction To support innovation from smaller organizations, the FDA has a Small Business Determination (SBD) program that allows eligible companies to pay a significantly reduced user fee for De Novo requests and other submission types. #### General Eligibility and Process 1. **Eligibility Criteria:** A company, along with its affiliates, must meet the FDA's definition of a small business, which is primarily based on gross receipts or sales. The specific revenue threshold is defined by the FDA and can be found on their website. Sponsors must review the latest criteria to confirm their eligibility. 2. **SBD Application:** To qualify, a sponsor must submit a specific SBD application form to the FDA's Center for Devices and Radiological Health (CDRH). This application requires providing financial documentation, such as federal income tax returns, to verify the company's size. 3. **FDA Review and Approval:** The FDA reviews the SBD application and, if the criteria are met, issues an official SBD approval letter. This letter is valid for the fiscal year in which it is granted. 4. **Timing the Application:** It is crucial for sponsors to submit their SBD application well in advance of their planned De Novo submission. The SBD must be approved *before* the De Novo request is submitted. The review process for an SBD application can take several weeks, so early planning is essential to avoid delays. When the De Novo request is submitted, it must include a copy of the SBD approval letter to justify payment of the lower fee. ### Strategic Considerations and the Role of Q-Submission While the Q-Submission program is not the channel for asking about user fee amounts, it is an invaluable tool for overall De Novo strategy. Before a sponsor commits resources to a submission and pays the associated user fee, confirming the regulatory pathway is a critical step. A Pre-Submission (Q-Sub) meeting allows a sponsor to present their device, proposed intended use, and testing strategy to the FDA. This engagement can provide crucial feedback on whether the De Novo pathway is appropriate or if another pathway, such as a 510(k) or PMA, might be expected. Clarifying the pathway and testing requirements early can prevent costly missteps, making the eventual user fee a more effective investment in a well-prepared submission. Early dialogue with the FDA helps ensure that the data package is aligned with agency expectations before the formal review clock and user fee payment begin. ### Key FDA References - FDA's Medical Device User Fee Amendments (MDUFA) Webpage - FDA's De Novo Classification Request Guidance - FDA's Q-Submission Program Guidance - 21 CFR Part 807, Subpart E – Premarket Notification Procedures ### How tools like Cruxi can help Navigating the regulatory process requires meticulous organization. Tools designed for regulatory affairs can help teams manage the extensive documentation required for a De Novo submission, track key deadlines for processes like the Small Business Determination application, and structure the submission to align with FDA guidance. By centralizing evidence and building a clear regulatory plan, sponsors can approach submissions with greater confidence and efficiency. 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.