FDA Increases Fees by up to 21% for Fiscal Year 2025: What You Need to Know.
The FDA (Food and Drug Administration) announced on August 1, 2024, the new fees for Fiscal Year 2025 (FY25).
Companies that manufacture or distribute medical devices for the US must register annually with the FDA. This process is called Establishment Registration and it’s mandatory.
If your company manufactures, distributes, or imports medical devices for the US, even if only for export, annual registration with the FDA is mandatory. Additionally, most registered establishments also need to list their devices and related activities.
Below is a comparison between fiscal years 2024 and 2025:
Annual Establishment Registration Fee:
From: USD 7,653.00- To: USD 9,280.00
- Increase: USD 1,627.00 (approximately 21%).
For the other fees, the increase was approximately 10,6%.
See the table below:
| Fiscal Year: | 2024 | 2025 | ||
|---|---|---|---|---|
| Application Type | Standard Fee | Small Business Fee† | Standard Fee | Small Business Fee† |
| 510(k)‡ | $ 21,760.00 | $ 5,440.00 | $ 24,335.00 | $ 6,084.00 |
| 513(g) | $ 6,528.00 | $ 3,264.00 | $ 7,301.00 | $ 3,650.00 |
| PMA, PDP, PMR, BLA | $ 483,560.00 | $ 120,890.00 | $ 540,783.00 | $ 135,196.00 |
| De Novo Classification Request | $ 145,068.00 | $ 36,267.00 | $ 162,235.00 | $ 40,559.00 |
| Panel-track Supplement | $ 386,848.00 | $ 96,712.00 | $ 432,626.00 | $ 108,157.00 |
| 180-Day Supplement | $ 72,534.00 | $ 18,134.00 | $ 81,117.00 | $ 20,279.00 |
| Real-Time Supplement | $ 33,849.00 | $ 8,462.00 | $ 37,855.00 | $ 9,464.00 |
| BLA Efficacy Supplement | $ 483,560.00 | $ 120,890.00 | $ 540,783.00 | $ 135,196.00 |
| 30-Day Notice | $ 7,737.00 | $ 3,869.00 | $ 8,653.00 | $ 4,326.00 |
| Annual Fee for Periodic Reporting on a Class III device (PMAs, PDPs, and PMRs) | $ 16,925.00 | $ 4,231.00 | $ 18,927.00 | $ 4,732.00 |
The FDA (Food and Drug Administration) fiscal year runs from October 1 to September 30 of the following year. Thus, the aforementioned fees refer to the period from October 1, 2024, to September 30, 2025.
For the renewal of the establishment registration (fundamental step for those who want to keep their registration active with the FDA, with the possibility of selling the product in the American market), the fee payment window is between October 1, 2024 and December 31, 2024.
Passarini Group is committed to facilitating access to the American market.
In addition to keeping you informed about updates, we are working to streamline the Small Business certification application process. Stay tuned for news coming soon!
For further information, assistance in the registration or renewal process, Small Business certification, US Agent, 510(k) submission process, and other activities, contact Passarini Group! It will be a pleasure to help you via email at: contato@passarini.com.br
Passarini Group
Published on: 08/09/2024
