美國FDA於8月1日公告2020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2019.10.01到2020.09.30。

 

年度註冊費(Annual Establishment Registration)為USD$ 5,236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. Dallars)

Small Business Fee (U.S. Dollars)

510(k)

$11,594

$2,899

513(g)

$4,603

$2,302

De Novo classification request

$102,299

$25,575

PMA, PDP, PMR, BLA

$340,995

$85,249

Panel-track supplement

$255,747

$63,937

180-day supplement

$51,149

$12,787

Real-Time supplement

$23,870

$5,968

BLA efficacy supplement

$340,995

$85,249

Annual Report

$11,935

$2,984

30-day notice

$5,456

$2,728

arrow
arrow
    創作者介紹
    創作者 M.D. 的頭像
    M.D.

    M.D.'s Blogger

    M.D. 發表在 痞客邦 留言(0) 人氣()