FY2022

(small business fee)

F2021

(small business fee)

Change

Premarket application (PMA )

$374,858
($93,714)                               

$365,657
($91,414)

$9,201
($2,300)

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

$374,858
($93,714)

$365,657
($91,414)

$9,201
($2,300)

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

$374,858
($93,714)

$365,657
($91,414)

$9,201
($2,300)

Panel-track supplement

$281,143
($70,286)

$274,243
($68,561)

$6,900
($1,725)

De novo classification request

$112,457
($28,114)

$109,697
($27,424)

$2,760
($690)

180-day supplement

$56,229
($14,057)

$54,849
($13,712)

$1,380
($345)

Real-time supplement

$26,240
($6,560)

$25,596
($6,399)

$644
($161)

510(k) premarket notification submission

$12,745
($3,186)

$12,432
($3,108)

$313
($78)

30-day notice

$5,998
($2,999)

$5,851
($2,926)

$147
($73)

513(g) request for classification information

$5,061
($2,530)

$4,936
($2,468)

$125
($62)

Annual fee type 

–    Annual fee for periodic reporting on a Class III device

$13,120
($3,280)

$12,798
($3,200)

$322
($80)

–    Annual establishment registration fee

$5,672
($5,672)

$5,546
($5,546)

$126
($126)