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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