User Fees for FY2022
Annual Establishment Registration Fee: $5,672
Below are the Fees for Fiscal year 2022 (October 1, 2021 through September 30, 2022):
All establishments must pay the establishment registration fee. There are no waivers or reductions for small establishments, businesses, or groups.
Other fees for Fiscal Year 2022 (October 1, 2021 through September 30, 2022) are:
| Application Type | Standard Fee | Small Business Fee† |
|---|---|---|
| 510(k) | $12,745 | $3,186 |
| 513(g) | $5,061 | $2,530 |
| PMA,PDP,PMR,BLA | $374,858 | $93,714 |
| De Novo Classification Request | $112,457 | $28,114 |
| Panel-track Supplement | $281,143 | $70,286 |
| 180-Day Supplement | $56,229 | $14,057 |
| Real-Time Supplement | $26,240 | $6,560 |
| BLA Efficacy Supplement | $374,858 | $93,714 |
| 30-Day Notice | $5,998 | $2,999 |
| Annual Fee for Periodic Reporting on a Class III device (PMAs,PDPs, and PMRs) | $13,120 | $3,280 |
† Small Business Fee: For businesses certified by the Center for Devices and Radiological Health (CDRH) as a small business..
‡ 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.