FDA 510(k) Fees: MDUFA V User Fee Schedule and Total Cost Breakdown

Every medical device company that files a 510(k) premarket notification with the FDA must pay a user fee before the agency will begin its review. For fiscal year 2026, that standard fee is $26,067 — or $6,517 if your company qualifies as a small business. But the user fee is only one line item in the overall cost of achieving 510(k) clearance.

This guide covers every FDA user fee that applies to 510(k) submissions under the MDUFA V fee schedule for FY 2026 (October 1, 2025 through September 30, 2026), explains how to qualify for the small business discount, details available waivers and exemptions, walks through the payment process, and breaks down the total project cost you should budget for beyond the user fee alone.

FY 2026 MDUFA V User Fee Schedule

The FDA publishes user fees each fiscal year under the Medical Device User Fee Amendments (MDUFA). The current cycle, MDUFA V, is authorized through September 2027. Fees are set annually by Federal Register notice following consultation with industry and adjustment for inflation and workload factors.

The FY 2026 fees, effective October 1, 2025, represent increases of approximately 7% for application fees and a notable 23% jump for establishment registration compared to FY 2025. The complete schedule is as follows:

Key point on 510(k) fees: All three 510(k) pathways — Traditional, Abbreviated, and Special — are subject to the same user fee. There is no reduced fee for an Abbreviated or Special 510(k). The small business rate of $6,517 represents a 75% discount off the standard fee and is the single most impactful cost-saving mechanism available to qualifying companies.

The fees above are drawn from the official FDA MDUFA fees page and the Federal Register notice published July 30, 2025 (document 2025-14412).

Establishment Registration Fee: What Changed in FY 2026

The annual establishment registration fee stands apart from the application fees in two important ways.

No small business reduction. Unlike the 510(k) and PMA application fees, the establishment registration fee has no reduced small business rate. Every registered device establishment pays the same $11,423 regardless of company size or revenue. This fee is required annually for any facility that manufactures, prepares, propagates, compounds, or processes a medical device for commercial distribution in the United States.

A sharp increase. The FY 2026 registration fee jumped approximately 23% from the FY 2025 level, making it one of the largest year-over-year increases in the MDUFA V cycle. Companies budgeting on prior-year numbers should update their forecasts accordingly.

New FY 2026 waiver opportunity. For the first time under MDUFA V, the FDA is authorized to waive the establishment registration fee for qualifying small businesses. To be eligible, a company must have gross receipts and revenues of $1 million or less (including affiliates), demonstrate financial hardship, and have paid the establishment registration fee for the prior fiscal year. This waiver is intended for very early-stage companies that may find the $11,423 registration fee disproportionately burdensome. Companies should consult the FDA's Small Business Determination (SBD) program page for details on how to request this waiver.

Small Business Determination Program

The small business fee rate can reduce a 510(k) filing from $26,067 to $6,517 — a savings of nearly $20,000. For a De Novo submission, the discount saves over $130,000. Qualifying is straightforward but requires advance action.

Qualification Criteria

To qualify as a small business for FY 2026 user fee purposes, your company (including all parent companies, subsidiaries, and affiliates worldwide) must have had gross receipts and revenues of $100 million or less during the most recent tax year. The $100 million threshold applies to the combined revenue of the entire corporate family, not just the filing entity.

How to Apply

1. Submit a Small Business Request (SBR) through the CDRH Portal (the FDA's online submission system for regulatory transactions).
2. Provide supporting documentation, typically your most recent federal tax return showing gross receipts. The FDA may request additional documentation for affiliates.
3. Meet the application window. SBRs are accepted from August 1 through September 30 before the start of the fiscal year for which you are seeking qualification. For FY 2026, that window ran from August 1, 2025 to September 30, 2025. Companies that miss the window must wait until the next cycle.
4. Receive your Small Business Determination letter. The FDA reviews SBRs and issues determination letters. You must include a copy of this letter with your fee payment and submission to receive the reduced rate.

Important Details

• The determination is valid for one fiscal year only. You must reapply annually.
• If your company is acquired by or merges with a larger entity after receiving a determination, the reduced fee may no longer apply to submissions made after the change in ownership.
• The SBD program applies to all application fee types that offer a small business rate, not just 510(k) submissions.
• Foreign companies can also qualify. The revenue threshold applies regardless of where the company is headquartered.

Fee Waivers and Exemptions

Beyond the small business discount, several specific waivers and exemptions can eliminate or reduce user fees.

First PMA / BLA / PDP / PMR Fee Waiver

A company with gross receipts and revenues of $30 million or less (including affiliates) is eligible for a full waiver of the first PMA, PDP, PMR, or BLA fee. This is a one-time waiver — it applies only to the first such application the company submits. Subsequent PMA or BLA submissions are subject to the small business rate ($144,818) but are no longer free.

This waiver does not apply to 510(k) submissions. The 510(k) small business rate of $6,517 is the lowest available fee for that pathway.

Government Entities and Academic Institutions

Federal government agencies, state and local government entities, and certain public nonprofit organizations may qualify for fee waivers. These are evaluated on a case-by-case basis and require a written request to the FDA.

Third-Party 510(k) Review

A device eligible for third-party review can be submitted through an FDA-recognized third-party review organization rather than directly to the FDA. In this pathway, no FDA 510(k) user fee is assessed. Instead, the company pays the third-party review organization directly for its review services. The fee negotiated with the third party is typically lower than the FDA's standard rate, though it varies by reviewer and device type.

Third-party review is available for lower-risk device classifications and specific product codes designated by the FDA. Companies should verify whether their device is eligible before pursuing this route.

How to Pay FDA User Fees

Getting the payment right is critical. The FDA will not begin review of your 510(k) until the user fee is paid in full and matched to your submission.

Step-by-Step Payment Process

1. Obtain a Payment Identification Number (Payment ID). Before submitting your 510(k), generate a Payment ID through the FDA's User Fee System, accessible via the CDRH Portal. This unique identifier links your payment to your submission.

2. Submit payment. Pay the fee electronically through the U.S. Treasury's Pay.gov system using the Payment ID. Accepted methods include ACH debit, credit card, and wire transfer. For FY 2026, the FDA has updated its payment portal integration — always verify the current payment link on the FDA's official Medical Device User Fees page rather than using a cached or bookmarked URL.

3. Include proof of payment with your submission. When you submit your 510(k) via the FDA's electronic submission process, include the Payment ID and a copy of your payment confirmation (cover sheet). This allows the FDA to verify that fees have been paid.

4. Timing matters. The fee must be paid for the fiscal year in which the FDA receives your submission. If you submit on September 30, 2026 (the last day of FY 2026), you pay FY 2026 rates. If you submit on October 1, 2026, you pay FY 2027 rates — which will likely be higher.

Common Payment Pitfalls

• Paying under the wrong Payment ID. Each submission needs its own Payment ID. Reusing an ID from a prior submission will cause a mismatch.
• Paying after submission. The FDA requires the fee to be paid when the submission is received. If payment is not confirmed, the submission goes on hold and review does not begin.
• Incorrect fee amount. Verify you are paying the correct rate (standard vs. small business) and for the correct fiscal year. The small business rate requires a valid SBD letter.

Beyond the User Fee: Total 510(k) Project Cost

The FDA user fee is a known, published cost. But it represents only a fraction of the total investment required to achieve 510(k) clearance. The total project cost for a 510(k) filing — including testing, consulting, quality system setup, and the user fee itself — typically ranges from $20,000 to $80,000 or more, depending on device complexity, novelty, and the company's existing infrastructure.

Cost Breakdown by Category

FDA user fee: $6,517 to $26,067 The single largest line item for most small companies is the user fee itself. A qualifying small business pays $6,517; larger companies pay $26,067.

Bench and performance testing: $5,000 to $50,000+ Most 510(k) submissions require substantial performance data to demonstrate substantial equivalence to a predicate device. Costs vary enormously by device type. A simple Class II device with well-established test methods may require $5,000–$15,000 in testing. Devices requiring biocompatibility testing (ISO 10993 series), electrical safety and electromagnetic compatibility (IEC 60601 series), software validation, or animal studies can easily exceed $50,000.

Regulatory consulting and preparation: $5,000 to $25,000 Many companies — especially first-time submitters — engage regulatory consultants to prepare the 510(k) submission, develop the substantial equivalence argument, compile the testing summary, and manage the filing process. Hourly rates for experienced regulatory consultants typically range from $150 to $400 per hour, with a full 510(k) preparation engagement spanning 40 to 100+ hours.

eSTAR template completion: included in consulting or $2,000–$5,000 standalone Since October 2023, the FDA's electronic Submission Template And Resource (eSTAR) is mandatory for all 510(k) submissions. eSTAR provides a structured, PDF-based template that guides submitters through the required content. While some companies complete it themselves, many hire consultants to ensure the content meets FDA expectations.

Quality Management System (eQMS) setup: $3,000 to $20,000 Although a full quality system is not always required at the time of 510(k) submission (it becomes essential for compliance with 21 CFR 820 upon commercialization), many companies invest in establishing their electronic quality management system during the 510(k) process. Software subscriptions range from $200 to $2,000 per month, and initial setup with SOP development can cost $3,000–$20,000 depending on company size and product complexity.

Labeling and design controls documentation: $2,000 to $10,000 Proper labeling that meets FDA requirements (21 CFR 801, 809, 812 as applicable) and design history file documentation are essential components of the 510(k). These costs are often bundled into consulting fees but can be significant standalone expenses.

Establishment registration: $11,423 (annual) Don't forget this recurring cost. If your company has not previously registered its manufacturing establishment with the FDA, the $11,423 annual registration fee applies. This is separate from the 510(k) user fee and must be paid each year.

Illustrative Total Cost Scenarios

These estimates are illustrative. Actual costs depend heavily on device type, predicate availability, the company's internal capabilities, and whether additional testing iterations are needed to meet performance requirements.

Fee Trends: What to Expect for FY 2027

MDUFA V fees have risen every year of the current authorization cycle, and FY 2027 will likely continue that trend. Several factors drive the increases:

• Statutory inflation adjustments. MDUFA V includes built-in annual adjustments tied to the Consumer Price Index and FDA workload measures.
• Workload growth. The FDA continues to receive a growing volume of 510(k) submissions, particularly in digital health, software as a medical device (SaMD), and combination products, which increases total program costs.
• Establishment registration baseline shift. The 23% increase in the registration fee for FY 2026 suggests that this particular line item may continue to rise sharply as the FDA adjusts its cost allocation between application fees and registration fees.

Based on the historical trajectory under MDUFA V, companies should budget for FY 2027 510(k) application fees in the range of $27,000–$28,000 at the standard rate and $6,800–$7,000 at the small business rate. These are estimates; the actual FY 2027 fees will be published by Federal Register notice in mid-2026.

MDUFA V expires at the end of FY 2027 (September 30, 2027). The FDA and industry will negotiate the terms of MDUFA VI before then, which will set the fee framework for the following five-year period. Companies should watch for public meetings and Federal Register announcements about MDUFA VI negotiations, as the new agreement could reshape the fee structure significantly.

Key Takeaways for Budget Planning

1. Lock in small business status early. The SBD application window closes September 30 each year. If your company qualifies, applying on time saves roughly $20,000 per 510(k) filing. There is no downside to applying even if you are unsure whether you will file.

2. Budget for the total project, not just the user fee. For most companies, the user fee represents 15%–50% of the total cost of a 510(k) clearance project. Testing and consulting are typically larger cost drivers.

3. Don't forget establishment registration. At $11,423 per year with no small business discount (unless you qualify for the new FY 2026 hardship waiver), this recurring fee is a significant line item that first-time submitters often overlook.

4. Consider third-party review if eligible. If your device qualifies for third-party 510(k) review, you can avoid the FDA user fee entirely. The trade-off is paying the third-party reviewer, but the total cost is often lower.

5. Time your submission to the fiscal year boundary. If you are close to the end of a fiscal year, filing before October 1 locks in the current year's rates. Given annual fee increases, filing even a few weeks earlier can save money.

6. Plan for fee increases. Budget 7%–10% annual increases when forecasting costs for submissions planned more than one fiscal year out.

7. Factor in the first PMA waiver strategically. If your company qualifies (revenue under $30 million) and you plan to submit a PMA in the future, be aware that the first one can be free. Coordinate with your regulatory team to ensure this waiver is applied to your most expensive planned submission.

Understanding the full user fee landscape is an essential part of regulatory planning. The fees are published, predictable, and in many cases significantly reducible through the small business program. But they are only one component of the total investment required to bring a medical device to market in the United States. By accounting for testing costs, consulting, quality system infrastructure, and registration fees alongside the user fee itself, companies can build realistic budgets that avoid surprises during the 510(k) process.

Sources: FDA MDUFA Fees page (fda.gov/industry/fda-user-fee-programs/medical-device-user-fee-amendments-mdufa-fees); Federal Register notice July 30, 2025 (2025-14412); FDA Medical Device User Fees page (fda.gov/medical-devices/premarket-submissions/medical-device-user-fees); FDA Small Business Determination (SBD) Program page (fda.gov/medical-devices/premarket-submissions/reduced-or-waived-medical-device-user-fees-small-business-determination-sbd-program).