The FDA has announced new fees for fiscal year 2017/2018, which will be effective as of October 1, 2017 until September 30, 2018.
More specifically:
- Establishment registration fee
This fee shall be paid between October 1 and December 31, 2017. For 2018 the amount for each establishment is $4,642 (U.S.)
- FY18 user fees for applications
| Application Type | Standard Fee 2018 | Small Business Fee 2018 |
| 510(k) | $10,566 | $2,642 |
| 513(g) | $4,195 | $2,098 |
| PMA/PDP/PMR/BLA | $310,764 | $77,691 |
| Panel-track Supplement | $233,073 | $58,268 |
| 180-day Supplement | $46,615 | $11,654 |
| Real-time Supplement | $21,753 | $5,438 |
| BLA Efficacy Supplement | $310,764 | $77,691 |
| PMA Annual Report | $10,877 | $2,719 |
| 30-day Notice | $4,972 | $2,486 |
| De Novo classification | $93,017 | $23,254 |
The updated amounts refer to all practices submitted to the FDA after October 1, 2017.
For more information: https://www.fda.gov/ucm/groups/fdagov-public/@fdagov-meddev-gen/documents/document/ucm573375.pdf
