FDA FY 2027 Medical Device User Fees: Full Fee Table

The U.S. Food and Drug Administration (FDA) published its fiscal year 2027 medical device user fee schedule on 30 July 2026. The rates apply to qualifying submissions and annual fees from 1 October 2026 through 30 September 2027.

Most standard submission fees increase by approximately 9.9% from FY 2026. The annual establishment registration fee rises more sharply—from $11,423 to $13,785, an increase of $2,362 or approximately 20.7%. Those percentages are Pure Global calculations from FDA's official FY 2026 and FY 2027 tables; FDA publishes the dollar rates, not the year-over-year percentages.

Read the FY 2027 notice in the Federal Register. The notice is document 2026-15335, Docket FDA-2026-N-7492, published at 91 FR 48134.

Complete FY 2027 fee table and FY 2026 comparison

Percentage changes are calculated from the official FY 2026 notice and rounded to one decimal place. FDA rounds individual fees to whole dollars, so changes in the smaller fee categories do not produce exactly the same unrounded percentage.

Why the establishment fee rises faster

FDA's notice explains two layers of adjustment. First, the FY 2027 statutory base fees and revenue target are adjusted for inflation and then increased as needed to meet the inflation-adjusted revenue amount. That process produces the $636,732 standard premarket-application fee used to calculate the percentage-based submission fees.

The annual establishment fee then receives an additional MDUFA V performance-improvement adjustment. FDA reports that it met the FY 2025 pre-submission written-feedback goal and the FY 2024 De Novo decision goal, creating a $63,542,885 FY 2027 performance-improvement adjustment. Under the statute, that adjustment is applied through establishment registration fees. FDA reports no FY 2027 hiring or operating-reserve reduction to offset it, producing the final $13,785 establishment fee.

This distinction explains why applying a single “about 10%” inflation factor to a U.S. regulatory budget would understate the cost of establishment registration.

What the fee change does to common budgets

The submission fee is only one line in a market-entry budget. When an applicant also needs to pay the annual registration fee for one establishment, the combined government-fee change is larger than the submission percentage alone suggests.

These examples are Pure Global calculations. They assume one submission and one establishment registration fee; they exclude consulting, testing, eSTAR preparation, clinical work, U.S. agent services, and any additional establishments. The establishment fee is assessed per fee-paying establishment, so organizations should budget from their actual establishment structure rather than treat it as one company-wide charge.

Small-business reductions and limits

FDA's FY 2027 notice preserves three distinct thresholds:

• A business, including affiliates, with no more than $100 million in gross receipts or sales for the most recent tax year may qualify for reduced fees on eligible submissions.
• A qualifying business with no more than $30 million in gross receipts or sales may also qualify for a waiver of its first premarket application or premarket report fee.
• For the annual establishment registration fee, FDA may—but is not required to—grant a financial-hardship waiver to a qualifying small business with no more than $1 million in gross receipts or sales. The waiver excludes initial registration.

The ordinary small-business discount does not reduce the establishment registration fee: FDA's Table 5 lists $13,785 in both the standard and small-business columns. The possible hardship waiver is a separate, discretionary mechanism with narrower eligibility.

Small-business status is also fiscal-year specific. An FY 2026 determination expires on 30 September 2026; a company must qualify again for FY 2027 before using the FY 2027 reduced rates. FDA's Small Business Determination program page states that the FY 2027 application window opened on 1 August 2026 at 4:01 p.m. Eastern Time and that Small Business Requests are submitted electronically through the CDRH Portal.

FDA also warns that if a company submits an application before FDA determines that it qualifies, the company must pay the standard fee and FDA will not later refund the difference. The applicant and organization identity used for the determination must match the applicant paying for and named on the submission.

Which fiscal year controls the amount

The FY 2027 rates apply during the federal fiscal year, not the calendar year. For planning purposes, the important date is when the qualifying submission is received by FDA or the annual registration obligation is paid—not when development began, a contract was signed, or the fee notice was announced.

A team targeting the September/October boundary should therefore confirm the current FDA payment and submission instructions before generating a cover sheet or sending the submission. A filing that moves from 30 September to 1 October crosses into the new fee year and can change both the amount due and the small-business determination required.

Actions for regulatory and finance teams

1. Replace FY 2026 rates in every live budget and approval memo for submissions expected on or after 1 October 2026.
2. Model establishment fees by establishment, not by corporate group. The 20.7% increase can materially change multi-site renewal budgets.
3. Renew small-business status for FY 2027 before relying on a reduced fee. Do not assume an FY 2026 determination rolls forward.
4. Do not submit first and qualify later. FDA says it will not refund the standard-versus-small-business difference when qualification is obtained after submission.
5. Separate ordinary fee reductions from the hardship waiver. The establishment fee has no routine discounted rate, and the possible waiver has its own conditions.
6. Add a fiscal-year boundary check to submission readiness. A schedule slip across 1 October should automatically trigger a fee and determination review.

For pathway context, see Pure Global's U.S. medical device market-access guide, 510(k) submission guide, and FDA establishment registration and device listing guide.

The practical conclusion is not simply that FDA fees increased. FY 2027 creates two different budgeting movements: an approximately 9.9% increase across submission categories and a 20.7% increase in annual establishment registration. Companies that model both, verify the fiscal-year boundary, and secure the correct Small Business Determination before filing will avoid the most predictable fee errors.