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。
2019年收費標準(表格內單位為美金)
|
Application Type |
Standard Fee |
Small Business Fee |
|---|---|---|
|
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 |
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