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FDA User Fee Calculator FY2027

Get your FY2027 FDA user fee total in a minute, including small business rates.

  • A line-by-line totalEvery submission and annual fee you expect, priced and added up.
  • The small business priceWhat you would pay with an approved Small Business Determination (SBD).
  • Your next stepsWhen to request the SBD and when to pay, so FDA starts the review.
Calculate my feesFree · No sign-up · FDA fee rates as of October 1, 2026

The short answer

In FY2027 (October 1, 2026 to September 30, 2027), a 510(k), FDA’s premarket notification, costs $28,653 in FDA user fees. With an approved Small Business Determination (SBD), a small business pays $7,163.

How it works

  1. Enter what you will filePut in how many 510(k)s, De Novo requests, registrations or other fees you expect, and your gross receipts.
  2. We apply the FY2027 ratesEach line gets the standard or small business fee FDA published in the Federal Register on July 30, 2026.
  3. Your total and next stepsYou see the total, what an approved SBD would save you and what to do before you submit.

FDA user fees for FY2027

The small business column applies once FDA approves your SBD and your gross receipts or sales, including affiliates, are $100 million or less. It comes to 25% of most fees and 50% for 30-day notices and 513(g) requests. At $30 million or less, the fee for your first premarket approval (PMA), PDP, BLA or premarket report is waived.

SubmissionStandard feeSmall business fee
510(k) premarket notification$28,653$7,163
De Novo classification request$191,020$47,755
PMA, PDP, BLA or premarket report (original)$636,732$159,183
Panel-track supplement$509,386$127,347
180-day supplement$95,510$23,878
Real-time supplement$44,571$11,143
30-day notice$10,188$5,094
513(g) request for classification information$8,596$4,298
Annual fee for periodic reporting (Class III)$22,286$5,572
Annual establishment registration$13,785no reduced rate
Source: Federal Register, July 30, 2026.

The calculator adds up FDA user fees. It does not decide your pathway or how many submissions you need, and it does not request the SBD for you. The total is an estimate, not an invoice: FDA sets the amount on your user fee cover sheet.

What OVA does here, and where our responsibility ends

220devices developed62engineers$125per hourISO 13485certified quality system

We design the electronics, firmware and mechanics of medical devices and take them from concept to design for manufacturing. We are not a regulatory consultancy and not a contract manufacturer: the regulatory strategy and the submission stay with you or your regulatory consultant.

The result is an orientation, not a regulatory opinion. Confirm the pathway and the fees with a regulatory specialist or through a Pre-Submission (Q-Sub) with FDA. The tool runs in your browser. Your answers are not sent to us; with your cookie consent, Google Analytics records only that the tool was used and the category of the result.

Questions

How long does an SBD take?

FDA aims to decide within 60 calendar days, and until then you pay the standard fee. So request it in the CDRH Portal before you submit.

When do I pay the user fee?

At or before the time you send the submission. Without full payment, FDA considers the submission incomplete and does not start the review.

Do small businesses pay less for establishment registration?

No, everyone pays $13,785 in FY2027. FDA may waive the annual fee, though not the initial one, if your gross receipts are $1 million or less and paying it is a financial hardship. FDA says the only case it currently knows is active bankruptcy.

How much is the De Novo fee?

It is $191,020 in FY2027, or $47,755 with an approved SBD.

Does the calculator include development costs?

No, it counts only FDA user fees. Test labs, clinical studies and engineering usually cost more than the fees, and our cost calculator estimates the engineering by phase.

Related pages

Sources

Data as of October 1, 2026. By Lisa Voronkova, CEO of OVA Solutions. Updated on October 22, 2026.

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