FDA2018财政年度收费价格

发布时间:2022-07-01 浏览量: 667

FDA收费价格(2017年10月1日)生效


 

申请类型

 

标准收费标准

 

小企业收费标准

510(K

$10,566

$2,642

513(g

$4,195

$2,098

De Novo classification

$93,229

$23,307

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