How much are the MDUFA user fees for a De Novo request?

## How to Determine MDUFA User Fees for a De Novo Request When preparing a De Novo Classification Request for a novel medical device, such as an AI-powered diagnostic software or a unique wearable biosensor, sponsors must account for the mandatory Medical Device User Fee Amendments (MDUFA) fee. This fee is a prerequisite for FDA review, and submitting a request without the correct payment can lead to administrative holds, delaying the review process. Determining the correct fee requires careful planning, as the amount is updated by the FDA for each federal fiscal year. Additionally, the FDA offers a Small Business Determination (SBD) program, which provides a significant fee reduction for eligible companies. To qualify, a company must meet specific revenue criteria and, critically, receive approval from the agency *before* submitting the De Novo request. This makes understanding the fee structure and the SBD application process a vital step in regulatory planning. ### Key Points * **Mandatory Payment:** A MDUFA user fee is required for all De Novo Classification Requests submitted to the FDA. * **Annual Updates:** Fee amounts are not static; they are updated annually for each U.S. government fiscal year (which begins on October 1st). * **Official Source is Key:** The only reliable source for the current fee schedule is the official FDA website. Sponsors should never rely on outdated information or third-party sources for fee amounts. * **Small Business Reduction:** A substantially reduced fee is available for sponsors who qualify for the FDA's Small Business Determination (SBD) program. * **Timing is Critical:** To take advantage of the reduced fee, a sponsor must apply for and receive SBD qualification from the FDA *before* submitting the De Novo request. The process can take several weeks, so early application is essential. * **Payment Accuracy:** Submitting the incorrect fee amount—whether too low or based on an unapproved small business status—will result in the submission being placed on hold until the discrepancy is resolved. ### Understanding De Novo MDUFA Fees The MDUFA program allows the FDA to collect fees from medical device companies to help fund the review process. For a De Novo request, this fee must be paid for the submission to be accepted for review. There are two primary fee tiers for a De Novo request: 1. **Standard Fee:** The full fee applicable to all companies that do not qualify as a small business. 2. **Small Business Fee:** A significantly reduced fee for companies that have successfully applied for and been granted Small Business Determination status by the FDA. Because these fees change each year, it is against best practices to list specific dollar amounts in planning documents. Instead, sponsors must refer directly to the FDA's official resources for the current rates. **For current FDA user fee information, sponsors should consult the FDA website at https://www.fda.gov/industry/fda-user-fees.** ### The Small Business Determination (SBD) Program The SBD program is designed to ease the financial burden on smaller companies bringing novel devices to market. To be eligible, a company (including its affiliates) must generally have gross receipts or sales below a certain threshold for the most recent tax year. The process typically involves the following steps: 1. **Confirm Eligibility:** Review the current eligibility criteria on the FDA's website. 2. **Submit the Application:** Complete and submit the appropriate MDUFA Small Business Qualification and Certification form. This requires providing financial documentation, such as federal income tax returns. 3. **Await FDA Review and Approval:** The FDA reviews the application, which can take up to 60 days. It is crucial to factor this timeline into the overall submission plan. 4. **Receive Qualification Number:** Once approved, the FDA will issue a Small Business Qualification Number. This number is valid until the end of the U.S. government's fiscal year. 5. **Submit De Novo with Correct Fee:** The sponsor can then submit the De Novo request, pay the reduced small business fee, and include the qualification number on the MDUFA cover sheet. Sponsors should apply for SBD status well in advance of their planned De Novo submission date to avoid delays. ### Strategic Considerations and the Role of Q-Submission Proper administrative and financial planning is a critical component of a successful regulatory strategy. Before paying a non-refundable De Novo user fee, sponsors should have a high degree of confidence that the De Novo pathway is appropriate for their device. Engaging with the FDA through the Q-Submission program can be an invaluable strategic step. A Pre-Submission (Pre-Sub) meeting allows sponsors to discuss their device and proposed regulatory strategy, including the rationale for pursuing a De Novo classification instead of a 510(k) or PMA. This early feedback can help confirm the regulatory path before significant resources, including the MDUFA user fee, are committed. Furthermore, planning for the SBD application timeline should be integrated into the overall project plan to ensure a smooth submission process. ### Key FDA references * FDA's MDUFA User Fee guidance documents. * FDA's guidance on the Small Business Determination (SBD) Program. * FDA's guidance on the De Novo Classification Process. * General regulations for premarket submissions found under 21 CFR. ### How tools like Cruxi can help Navigating the administrative requirements of a De Novo submission requires careful organization and timeline management. Tools like Cruxi can help teams structure their regulatory submission, track key milestones such as SBD application and approval, and manage the extensive documentation required. By centralizing submission content and project timelines, teams can ensure that critical administrative steps, like verifying the correct user fee and paying it on time, are not overlooked. 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.