The FDA announced the updated fees for the fiscal year 2018/2019 that will come into force starting from October 1, 2018 and will be valid until September 30, 2019.
More specifically:
- Establishment Registration Fee:
This fede shall be paid between October 1 and December 31, 2018. For the year 2019 the amount for each establishment is $ 4,884 (US $).
- FY19 user fees for applications:
| Application Type | Standard Fee 2019 | Small Business Fee 2019 |
| 510(k) | $10,953 | $2,738 |
| 513(g) | $4,349 | $2,175 |
| De Novo classification | $96,644 | $24,161 |
| PMA, PDP, PMR, BLA | $322,147 | $80,537 |
| Panel-track supplement | $241,610 | $60,403 |
| 180-day supplement | $48,322 | $12,081 |
| Real-time supplement | $22,550 | $5,638 |
| BLA efficacy supplement | $322,147 | $80,537 |
| Annual Report | $11,275 | $2,819 |
| 30-day notice | $5,154 | $2,577 |
The updated amounts refer to all applications submitted to the FDA after October 1, 2018.
For more information:
