最新資訊
2018-12-17 FDA公佈2019年醫療器材和學名藥送件收費標準
美國FDA於8月1日公告2019 年醫療器材各項申請費用，依據醫療器材使用者付費(Medical Device User Fees)，新的費用生效日期從2018.10.01到2019.09.30。
年度註冊費(Annual Establishment Registration)為USD$ 4,884；小型企業( small establishments, businesses, or groups)不得豁免或減少，所有企業必須支付全額年度註冊費。
|
Application Type
|
Standard Fee
(U.S. Dollars)
|
Small Business Fee
(U.S. Dollars)
|
|
Annual Establishment Registration
|
$4,884
|
$4,884
|
|
510(k)
|
$10,953
|
$2,738
|
|
513(g)
|
$4,349
|
$2,175
|
|
De Novo classification
|
$96,644
|
$24,161
|
|
PMA, PDP, PMR, BLA
|
$322,147
|
$80,537
|
|
panel-track supplement
|
$241,610
|
$60,403
|
|
180-day supplement
|
$48,322
|
$12,081
|
|
real-time supplement
|
$22,550
|
$5,638
|
|
BLA efficacy supplement
|
$322,147
|
$80,537
|
|
Annual Report
|
$11,275
|
$2,819
|
|
30-day notice
|
$5,154
|
$2,577
|
|
