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

## Understanding FDA User Fees for De Novo Classification Requests When a medical device manufacturer develops a novel, low-to-moderate risk device with no existing predicate, the De Novo Classification Request is often the appropriate regulatory pathway to market in the United States. A critical component of planning for this submission is understanding and budgeting for the associated user fees required by the FDA. These fees, authorized under the Medical Device User Fee Amendments (MDUFA), change annually and have different tiers, making it essential for sponsors to know how to determine the correct amount. The most significant factor influencing the De Novo user fee is whether the sponsoring organization qualifies as a "small business" as defined by the FDA. Qualifying for this status results in a substantially reduced fee, but it requires a separate, proactive application process that must be completed *before* the De Novo request is submitted. Therefore, sponsors must identify the correct fee schedule for the current fiscal year and understand the small business qualification process to ensure accurate financial planning and a smooth submission. ### Key Points * **MDUFA Authority:** The FDA is authorized by the Medical Device User Fee Amendments (MDUFA) to collect fees for the review of medical device submissions, including De Novo requests. * **Annual Fee Updates:** User fee amounts are updated for each U.S. government fiscal year, which runs from October 1st to September 30th. Sponsors must always verify the fee for the current year. * **Two Fee Tiers:** The FDA maintains a standard fee and a significantly lower fee for organizations that have been officially certified by the agency as a "small business." * **Pre-Qualification is Mandatory:** To pay the reduced small business fee, a company must first apply for and receive a Small Business Determination from the FDA. This approval must be obtained *before* paying the fee and submitting the De Novo request. * **Official Source is Key:** The only reliable source for current user fee rates is the official FDA website. Sponsors should never rely on outdated information or third-party sources for fee amounts. ### The De Novo User Fee Structure #### The Role of MDUFA The MDUFA program was established to provide the FDA with additional resources to conduct reviews of medical device submissions in a timely and predictable manner. The fees collected from industry, including those for De Novo requests, directly support the agency's review staff and infrastructure. As of 2024, these fees are a standard part of the regulatory submission process for most application types. #### Standard vs. Small Business Fees The FDA recognizes the financial burden that regulatory submissions can place on smaller organizations. To support innovation from startups and small companies, the MDUFA program includes a two-tiered fee structure. * **Standard Fee:** This is the full fee applicable to all organizations that do not qualify as a small business. * **Small Business Fee:** This is a substantially reduced fee available only to companies (including all affiliates, parent companies, and subsidiaries) that have received an official Small Business Determination from the FDA for the current fiscal year. It is critical for sponsors to understand that simply meeting the internal definition of a small business is not sufficient. The organization must complete the FDA's formal application process to be eligible for the lower rate. ### How to Determine the Correct Fee Navigating the user fee process involves a clear, sequential approach to ensure compliance and accurate budgeting. #### Step 1: Determine Eligibility for Small Business Status The first step for any sponsor is to review the FDA's criteria for a small business. While the specific revenue thresholds are updated periodically, the determination is generally based on the gross receipts or sales of the company and all of its affiliates. Sponsors should consult the FDA's guidance on the Small Business Determination Program for the precise criteria for the current year. #### Step 2: Apply for Small Business Determination (If Applicable) If a company believes it is eligible, it must submit a Small Business Certification Request to the FDA's Center for Devices and Radiological Health (CDRH). This application must be reviewed and approved by the FDA *before* the De Novo submission is filed. This process can take several weeks, so it is essential to plan ahead. Attempting to pay the lower fee without this prior approval will result in the De Novo submission being put on hold until the correct fee is paid. #### Step 3: Locate the Official FDA User Fee Schedule The FDA publishes the official MDUFA user fee schedule for each fiscal year on its website. Sponsors must refer to this official source to find the correct dollar amount for both standard and small business De Novo requests. For current and official FDA user fee information, sponsors should consult the FDA website directly at: **https://www.fda.gov/industry/fda-user-fees**. ### Strategic Considerations and the Role of Q-Submission Integrating user fee planning into the overall regulatory strategy is crucial. While the Q-Submission program is designed for questions related to the technical, scientific, and regulatory requirements of a submission, early engagement with the FDA can help confirm that the De Novo pathway is appropriate. This confirmation provides the certainty needed for accurate financial planning, allowing a sponsor to budget for the correct user fee well in advance. Proper planning prevents last-minute financial hurdles and ensures the administrative aspects of the submission are handled correctly. ### Key FDA References When planning for a De Novo submission, sponsors should refer to the latest versions of official FDA resources. - FDA's Medical Device User Fee Amendments (MDUFA) guidance documents. - FDA's guidance on the Small Business Determination Program. - FDA's guidance on the De Novo Classification Process. - General regulations for medical device submissions found under 21 CFR. ### How tools like Cruxi can help Effective regulatory planning involves managing numerous documents, timelines, and requirements. Tools like Cruxi can help teams organize their submission materials, track key milestones like the Small Business Determination application, and maintain a structured approach to their regulatory strategy, ensuring that administrative requirements like user fee payments 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.