FDA Announces Annual Fee Adjustment for Medical Devices.
The FDA (Food and Drug Administration) announced the new fees for Fiscal Year 2024 (FY24) in the last week, on August 9th, 2023.
Owners or operators of establishments that are involved in the production and distribution of medical devices intended for use in the U.S. are required to register annually with the FDA. This process is known as establishment registration (Title 21 CFR Part 807).
Who Must Register, List and Pay the Fee?
Establishments that are involved in the production and distribution of medical devices intended for commercial distribution in the United States (U.S.), including those that are imported for export only, are required to register annually with the FDA. Most establishments that are required to register are also required to list the devices and the activities performed on those devices at that establishment (Title 21 CFR Part 807).
Below is a comparison between fiscal years 2023 and 2024:
Annual Establishment Registration Fee:From: USD 6,493.00.
To: USD 7,653.00.
Approximately 18% increase. For the other fees, the increase was approximately 9.5%.
See the table below:
| Fiscal Year: | 2023 | 2024 | ||
|---|---|---|---|---|
| Application Type | Standard Fee | Small Business Fee† | Standard Fee | Small Business Fee† |
| 510(k)‡ | $19,870.00 | $4,967.00 | $21,760.00 | $5,440.00 |
| 513(g) | $5,961.00 | $2,980.00 | $6,528.00 | $3,264.00 |
| PMA, PDP, PMR, BLA | $441,547.00 | $110,387.00 | $483,560.00 | $120,890.00 |
| De Novo Classification Request | $132,464.00 | $33,116.00 | $145,068.00 | $36,267.00 |
| Panel-track Supplement | $353,238.00 | $88,309.00 | $386,848.00 | $96,712.00 |
| 180-Day Supplement | $66,232.00 | $16,558.00 | $72,534.00 | $18,134.00 |
| Real-Time Supplement | $30,908.00 | $7,727.00 | $33,849.00 | $8,462.00 |
| BLA Efficacy Supplement | $441,547.00 | $110,387.00 | $483,560.00 | $120,890.00 |
| 30-Day Notice | $7,065.00 | $3,532.00 | $7,737.00 | $3,869.00 |
| Annual Fee for Periodic Reporting on a Class III device (PMAs,PDPs, and PMRs) | $15,454.00 | $3,864.00 | $16,925.00 | $4,231.00 |
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, 2023, to September 30, 2024.
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, 2023 and December 31, 2023.
For further clarification, assistance with the registration or renewal process, Small Business certification, and other activities, please contact Passarini Group! We will be pleased to assist you via email: contato@passarini.com.br.
Passarini Group
Published: 8/14/2023 – Source: FDA
