News and analysis on medical technology

FDA Sets Fiscal 2027 Device User Fees; PMA Fee Rises to $636,732

Fees for the last year of MDUFA V go up about 10% for submissions, while the annual establishment registration fee climbs to $13,785 after a performance adjustment.

By News DeskJuly 30, 20262 min read
An anechoic test chamber lined with foam absorbers at the FDA
The anechoic chamber in FDA Building 62, the engineering and physics laboratory building that houses the Center for Devices and Radiological Health in Silver Spring, Maryland. U.S. Food and Drug Administration, Public domain, via Wikimedia Commons · Public domain (US government work; FDA Flickr, flickr.com/photos/fdaphotos/5160771795)

Key points

  • The FDA set medical device user fees for fiscal 2027, which runs from October 1, 2026 through September 30, 2027: $636,732 for a premarket approval application, $191,020 for a De Novo request and $28,653 for a 510(k).
  • The annual establishment registration fee will be $13,785, up from $11,423 in fiscal 2026, partly because the FDA met review goals that trigger a $63.5 million performance improvement adjustment.
  • Fiscal 2027 is the final year of the current MDUFA V authorization, which expires September 30, 2027.

The FDA on Thursday published the medical device user fee rates for fiscal 2027, raising the standard fee for a premarket approval (PMA) application to $636,732 and the annual establishment registration fee to $13,785.

The rates, set out in a Federal Register notice, apply from October 1, 2026 through September 30, 2027, the last year of the current Medical Device User Fee Amendments, MDUFA V. Under the law, most submission fees are set as a fixed percentage of the standard premarket application fee.

The new rates

Standard fees for fiscal 2027, with small business fees in parentheses, include:

  • PMA, product development protocol or biologics license application: $636,732 ($159,183).
  • Panel-track supplement: $509,386 ($127,347).
  • De Novo classification request: $191,020 ($47,755).
  • 180-day supplement: $95,510 ($23,878).
  • 510(k) premarket notification: $28,653 ($7,163).
  • Annual fee for periodic reporting on a class III device: $22,286 ($5,572).

In the fiscal 2026 notice, the PMA fee was $579,272, the De Novo fee $173,782, the 510(k) fee $26,067 and the establishment registration fee $11,423. That puts the submission fee increases at about 10% and the registration fee increase at about 21%. The registration fee has no small business discount, though the FDA may waive it, other than for an initial registration, for a small business if paying it would be a financial hardship, according to the notice. Companies with gross receipts or sales of no more than $100 million may qualify for reduced fees, and those at or below $30 million may also qualify for a waiver of the fee for their first premarket application.

How the FDA reached the numbers

The statute sets a fiscal 2027 total revenue amount of $418,343,000 before inflation. The FDA said its calculated inflation adjustment for the year, 4.573%, exceeded the 4% cap in the law, so it applied 4%. Compounded with earlier years, that produced an inflation-adjusted revenue target of $507,905,000.

Because projected collections at the inflation-adjusted base fees fell short of that target, the agency raised base fees proportionately and then raised registration fees further. It then added a performance improvement adjustment of $63,542,885, collected solely through registration fees, because it met its fiscal 2025 Pre-Submission written feedback goal and its fiscal 2024 De Novo decision goal.

No downward adjustments applied. The FDA said it met the fiscal 2025 statutory hiring threshold of 75 hires, so no hiring adjustment was needed, and its estimated end-of-year fiscal 2026 operating reserve of $139,866,752 was below the $190,482,628 level that would require a fee reduction.

The notice uses a three-year average of fee-paying submissions to project collections. It shows full-fee De Novo requests fell to 13 in fiscal 2025 from 26 in each of the two previous years, while small business De Novo requests numbered 49.

The current program expires on September 30, 2027. Earlier this month the FDA published proposed recommendations for its successor, MDUFA VI, covering fiscal 2028 through 2032.

Sources

  1. Medical Device User Fee Rates for Fiscal Year 2027, Federal Register, July 30, 2026
  2. Medical Device User Fee Rates for Fiscal Year 2026, Federal Register, July 30, 2025
  3. Medical Device User Fee Amendments; Public Meeting; Request for Comments, Federal Register, July 8, 2026