FDA announced new fees for the year 2015 with the publication in the Federal Register Notice on August 1, 2014.
In particular:
- Establishment registration fee
This fee must be paid between October 1, 2014 and December 31, 2014.
For the year 2015 the amount for each plant is $3,646 (U.S.).
- FY15 user fees for applications
| application type | standard fee | small business fee |
| 510(k) | $5,018 | $2,509 |
| 513(g) | $3,387 | $1,694 |
| PMA, PDP, PMR, BLA | $250,895 | $62,724 |
| panel-track supplement | $188,171 | $47,043 |
| 180-day supplement | $37,634 | $9,409 |
| real-time supplement | $17,563 | $4,391 |
| BLA efficacy supplement | $250,895 | $62,724 |
| annual report | $8,781 | $2,195 |
| 30-day notice | $4,014 | $2,007 |
If you want to apply the fees of 2014, the practice and the payment must be received by FDA no later than October 1, 2014.
The updated fees refers to all the practices submitted to FDA after October 1, 2014.
Source:
http://www.fda.gov/medicaldevices/resourcesforyou/industry/ucm407660.htm
