The U.S. Food and Drug Administration (FDA) has Announced the Fee Increase for 2026.
The fees for the fiscal year (FY) will take effect on 1 October 2025 and will remain in force until 30 September 2026.
Fees for the Fiscal Year 2026
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 2025 in US$ | SmB Fee 2025 in US$ | Standard Fee 2026 in US$ | SmB Fee 2026 in US$ | % Change Standard Fee | % Change SmB Fee |
| Annual Establishment Registration Fee | 9280 | n/a | 11423 | Waiver? | 23,1% | n/a |
| 510(k)‡ | 24335 | 6084 | 26067 | 6517 | 7,1 | 7,1 |
| 513(g) | 7301 | 3650 | 7820 | 3910 | 7,1 | 7,1 |
| PMA, PDP, PMR, BLA | 540783 | 135196 | 579272 | 144818 | 7,1 | 7,1 |
| De Novo Classification Request | 162235 | 40559 | 173782 | 43446 | 7,1 | 7,1 |
| Panel-track Supplement | 432626 | 108157 | 463418 | 115855 | 7,1 | 7,1 |
| 180-Day Supplement | 81117 | 20279 | 86891 | 21723 | 7,2 | 7,1 |
| Real-Time Supplement | 37855 | 9464 | 40549 | 10137 | 7,1 | 7,1 |
| BLA Efficacy Supplement | 540783 | 135196 | 579272 | 144818 | 7,1 | 7,1 |
| 30-Day Notice | 8653 | 4326 | 9268 | 4634 | 7,1 | 7,1 |
| Annual Fee for Periodic Reporting on a Class III device (PMAs, PDPs, and PMRs) | 18927 | 4732 | 20275 | 5069 | 7,1 | 7,1 |
Own representation based on: US Food & Drug Administration, 2025.
The FDA has increased most fees by around 7 per cent – a smaller increase than last year, when rates rose by an average of around 11 per cent. However, the increase in the Annual Establishment Registration Fee is more significant: it has been raised by 23%. This represents a considerable burden, especially for small and medium-sized enterprises, as there are no reduced small business fees for this charge. On average, however, the increase is still lower than in 2025, when the Annual Registration Fee had already risen by 21%.
Waiver for the Annual Registration Fee
It is possible to submit a special application for a waiver, i.e. a one-time suspension of the annual registration fee. However, this option is only available under extreme circumstances and only for companies that had already registered products with the FDA in FY 2025. Companies must meet the following requirements to apply for a waiver:
- Gross revenue of less than US$1 million.
- Evidence that payment of the fee for FY 2026 would financially threaten the company.
- Proof of payment of the fee for FY 2025.
Additional Information
In order for applications to be processed under the FY 2025 fees, companies must submit their applications to the FDA by 4 p.m. (ET or UTC -5) on 30 September 2025 at the latest. All applications submitted after this date will be subject to the 2026 fee. If the 2025 fee has already been paid, the difference (7.1%) must be paid and the FDA Form 3914 User Fee Payment Transfer Request" must be completed.
The Annual Registration Fee for FY 2026 must be paid between 1 October and 31 December 2025 – there are no penalties for late payment, but your registration status will become ‘inactive’. In this case, no further products may be imported or registered.
What Does it all Mean?
FY 2026 will also be more expensive. Small and medium-sized enterprises in particular are facing difficulties in view of the continuing rise in FDA fees.
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