Below are the Fees for Fiscal Year 2021 (October 1, 2020 through September 30, 2021):
The Fees for Fiscal Year 2021 (October 1, 2020 through September 30, 2021) are as follows:
| Application Type | Standard Fee | Small Business Fee† |
|---|---|---|
| 510(k)‡ | $12,432 | $3,108 |
| 513(g) | $4,936 | $2,468 |
| PMA, PDP, PMR, BLA | $365,657 | $91,414 |
| De Novo Classification Request | $109,697 | $27,424 |
| Panel-track Supplement | $274,243 | $68,561 |
| 180-Day Supplement | $54,849 | $13,712 |
| Real-Time Supplement | $25,596 | $6,399 |
| BLA Efficacy Supplement | $365,657 | $91,414 |
| 30-Day Notice | $5,851 | $2,926 |
| Annual Fee for Periodic Reporting on a Class III device (PMAs, PDPs, and PMRs) | $12,798 | $3,200 |
† For small businesses with an approved SBD.
‡ Note: 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.
Small businesses with an approved SBD with gross receipts or sales of $30 million or less are eligible to have the fee waived on their first PMA, PDP, PMR, or BLA.
Annual Establishment Registration Fee: $5,546.
There are no waivers or reductions for small establishments, businesses, or groups – all establishments must pay the establishment registration fee.