Application fee type

Standard fee (as a percent of the standard fee for a premarket application)

FY 2018 standard fee

FY 2018 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 (21 U.S.C. 360e(f), 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

$310,764

$77,691

Premarket report (submitted under section 515(c)(2) of the FD&C Act)

100

310,764

77,691

Efficacy supplement (to an approved BLA under section 351 of the PHS Act)

100

310,764

77,691

Panel-track supplement

75

233,073

58,268

De novo classification request

30

93,229

23,307

180-day supplement

15

46,615

11,654

Real-time supplement

7

21,753

5,438

510(k) premarket notification submission

3.40

10,566

2,642

30-day notice

1.60

4,972

2,486

513(g) request for classification information

1.35

4,195

2,098

Annual fee for periodic reporting on a class III device

3.50

10,877

2,719

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(13))

Base fee specified in statute

4,624

4,624