User Fees for FY 2025
Annual Establishment Registration Fee: $9,280
All establishments must pay the establishment registration fee. There are no waivers or reductions for small establishments, businesses, or groups in FY 2025.
Other fees for Fiscal Year 2025 (October 1, 2024, through September 30, 2025) are:
| Application Type | Standard Fee | Small Business Fee† |
|---|---|---|
| 510(k)‡ | $24,335 | $6,084 |
| 513(g) | $7,301 | $3,650 |
| PMA, PDP, PMR, BLA | $540,783 | $135,196 |
| De Novo Classification Request | $162,235 | $40,559 |
| Panel-track Supplement | $432,626 | $108,157 |
| 180-Day Supplement | $81,117 | $20,279 |
| Real-Time Supplement | $37,855 | $9,464 |
| BLA Efficacy Supplement | $540,783 | $135,196 |
| 30-Day Notice | $8,653 | $4,326 |
| Annual Fee for Periodic Reporting on a Class III device (PMAs,PDPs, and PMRs) | $18,927 | $4,732 |
† Small Business Fee: For businesses certified by the Center for Devices and Radiological Health (CDRH) as a small business. For more information, see the section Small Businesses below.
‡ 510(k) Fees: All types of 510(k)s (Traditional, Abbreviated, and Special) are subject to the user fee. However, there is no user fee for 510(k)s submitted to the FDA on behalf of an FDA-accredited third-party reviewer.