mdi ConsultantsFDA Update
With the New Fiscal Year Just Around the Corner the FDA announced the new USER FEE for ’25.
The FDA Has Just Announced Their User Fees for FY 2025
The FDA has again raised the user fees for the annual registration for medical devices along with all the required submissions. the FDA still has a small business discount for submissions but there is no small business discount for the annual registration.
All establishments must pay the establishment registration fee. There are no waivers or reductions for small establishments, businesses, or groups in FY 2025. The FDA just announced the annual establishment registration fee for 2025, which will be $9,280.00.
Other fees for Fiscal Year 2025 (October 1, 2024, through September 30, 2025) are as follows:
| Application Type | Standard Fee | Small Business Fee† |
| 510(k)‡ | $24,335.00 | $6,084.00 |
| 513(g) | $7,301.00 | $3,650.00 |
| PMA, PDP, PMR, BLA | $540,783.00 | $135,196.00 |
| De Novo Classification Request | $162,235.00 | $40,559.00 |
| Panel-track Supplement | $432,626.00 | $108,157.00 |
| 180-Day Supplement | $81,117.00 | $20,279.00 |
| Real-Time Supplement | $37,855.00 | $9,464.00 |
| BLA Efficacy Supplement | $540,783.00 | $135,196.00 |
| 30-Day Notice | $8,653.00 | $4,326.00 |
| Annual Fee for Periodic Reporting on a Class III device (PMAs,PDPs, and PMRs) | $18,927 | $4,732.00 |
Questions?
If you have any questions on FDA fees do not hesitate to contact mdi.
For more information on User Fees, please email us at: [email protected] and ref: User Fees.