The U.S. Food and Drug Administration (FDA) has announced the fee increase for 2027.
They apply from the 1st of October 2026 to the 30th of September 2027. The Annual Establishment Registration Fee rises by 20.7% to US$13,785. It falls due within the next three months: registration for fiscal year (FY) 2027 must be renewed and paid between the 1st of October and the 31st of December 2026.
Application fees are also rising, consistently by around 9.9%. A standard 510(k) will now cost US$28,653.
Fees for Fiscal Year 2027
The FDA charges ‘standard’ fees and ‘small business’ fees (hereinafter abbreviated as ‘SmB Fee’).
To be considered a ‘small business’ in the United States, medical device manufacturers must be recognised as such by the Centre for Devices and Radiological Health (CDRH).
The following table provides an overview based on figures published by the FDA – for the sake of consistency and clarity, the names are given in English.
| Application Type | Standard Fee 2026 in US$ | SmB Fee 2026 in US$ | Standard Fee 2027 in US$ | SmB Fee 2027 in US$ | % Change Standard Fee | % Change SmB Fee |
|---|---|---|---|---|---|---|
| Annual Establishment Registration Fee | 11.423 | n/a | 13.785 | n/a | 20,7% | n/a |
| 510(k)‡ | 26.067 | 6.517 | 28.653 | 7.163 | 9,9% | 9,9% |
| 513(g) | 7.820 | 3.910 | 8.596 | 4.298 | 9,9% | 9,9% |
| PMA, PDP, PMR, BLA | 579.272 | 144.818 | 636.732 | 159.183 | 9,9% | 9,9% |
| De Novo Classification Request | 173.782 | 43.446 | 191.020 | 47.755 | 9,9% | 9,9% |
| Panel-track Supplement | 463.418 | 115.855 | 509.386 | 127.347 | 9,9% | 9,9% |
| 180-Day Supplement | 86.891 | 21.723 | 95.510 | 23.878 | 9,9% | 9,9% |
| Real-Time Supplement | 40.549 | 10.137 | 44.571 | 11.143 | 9,9% | 9,9% |
| BLA Efficacy Supplement | 579.272 | 144.818 | 636.732 | 159.183 | 9,9% | 9,9% |
| 30-Day Notice | 9.268 | 4.634 | 10.188 | 5.094 | 9,9% | 9,9% |
| Annual Fee for Periodic Reporting on a Class III device (PMAs, PDPs, and PMRs) | 20.275 | 5.069 | 22.286 | 5.572 | 9,9% | 9,9% |
‡ The fee applies to all types of 510(k) (Traditional, Abbreviated and Special). No FDA fee is payable if the submission is made via an FDA-accredited third-party reviewer.) .
Own presentation based on: US Food & Drug Administration, 2026.
What Lies Behind the Figures
Application fees are rising considerably faster than last year. For FY 2026, the increase was around 7.1%; this year it is 9.9%. In absolute terms, a standard 510(k) costs US$2,586 more and a PMA application US$57,460 more.
The registration fee is rising slightly less sharply than last year (23.1%). Viewed over two years, however, the development is striking: from US$9,280 in FY 2025 to US$13,785 in FY 2027, an increase of 48.5%. As the fee is charged annually per establishment and no reduced small business fee is available, small and medium-sized manufacturers pay the same amount as large corporations.
FY 2027 is also the final year under the Medical Device User Fee Amendments V (MDUFA V), which apply until the 30th of September 2027. Reauthorisation as MDUFA VI is scheduled for 2027. How the fee structure will develop after that remains open.
Waiver for the Annual Registration Fee
Companies may submit a special request for a ‘waiver’, meaning the Annual Registration Fee is waived for the fiscal year in question. However, this option is only available under extreme circumstances and only to companies that have already paid a registration fee to the FDA in a previous fiscal year. To apply for a waiver, companies must meet the following requirements:
- Gross receipts or sales of US$1 million or less in the most recent tax year, including all affiliates.
- Proof of financial hardship based on a clear, objective and publicly transparent standard. Currently, only active bankruptcy is recognised.
- Evidence that the registration fee has already been paid under the company's own owner/operator number in a previous fiscal year.
The waiver is requested as part of a Small Business Request (SBR) via the CDRH Portal. For FY 2027, documents must be submitted by the 1st of November 2026.
Additional Information
For applications to be processed at FY 2026 rates, companies must submit them to the FDA by the 30th of September 2026 at the latest. The FY 2027 fee applies to all applications submitted after this date. If fees have already been paid at 2026 rates, the difference (9.9%) must be paid and Form FDA 3914 ‘User Fee Payment Transfer Request’ completed.
The Annual Registration Fee for FY 2027 must be paid between the 1st of October and the 31st of December 2026. Otherwise, the registration status becomes ‘inactive’. In this case, no further products may be imported into the United States.
Conclusion
FY 2027 will be more expensive once again. Small and medium-sized companies in particular face a challenging situation in light of the continued rise in FDA fees.
BEO BERLIN supports manufacturers with market access to the United States and acts as US-Agent. We also cooperate with FastCat Freight, a logistics provider with comprehensive coverage across North America. Our long-standing colleague Stephanie Bankston works there and is available to you as an experienced contact on the other side of the Atlantic – in German or English and with extensive expertise as a US Agent, so that your products reliably reach their destination.
Registration renewal for FY 2027 is due by the end of the year. We will be happy to support you.
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