US FDA Medical Device User Fee For FY2020 (Effective Oct 2020)
| Application Fee Type |
Standard Fee (as a percent of the standard fee for a premarket application) |
FY 2021 Standard Fee |
FY 2021 Small Business Fee |
| Premarket application (a PMA submitted under section 515(c)(1) of the FD&C Act (21 U.S.C. 360e(c)(1)), a PDP submitted under section 515(f) of the FD&C Act, or a BLA submitted under section 351 of the Public Health Service Act (the PHS Act) (42 U.S.C. 262)) |
Base fee specified in statute |
$365,657 |
$91,414 |
| Premarket report (submitted under section 515(c)(2) of the FD&C Act) |
100 |
$365,657 |
$91,414 |
| Efficacy supplement (to an approved BLA under section 351 of the PHS Act) |
100 |
$365,657 |
$91,414 |
| Panel-track supplement |
75 |
$274,243 |
$68,561 |
| De novo classification request |
30 |
$109,697 |
$27,424 |
| 180-day supplement |
15 |
$54,849 |
$13,712 |
| Real-time supplement |
7 |
$25,596 |
$6,399 |
| 510(k) premarket notification submission |
3.40 |
$12,432 |
$3,108 |
| 30-day notice |
1.60 |
$5,851 |
$2,926 |
| 513(g) request for classification information |
1.35 |
$4,936 |
$2,468 |
| Annual Fee Type |
|
|
|
| Annual fee for periodic reporting on a class III device |
3.50 |
$12,798 |
$3,200 |
| Annual establishment registration fee (to be paid by the establishment engaged in the manufacture, preparation, propagation, compounding, or processing of a device, as defined by 21 U.S.C. 379i(14)) |
Base fee specified in statute |
$5,546 |
$5,546 |