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美國FDA 2020年收費標準(October 1, 2019 through September 30, 2020)

張貼者:2019年7月31日 下午9:35Yuhua Chen   [ 已更新 2019年7月31日 下午10:34 ]

Application Type

Standard Fee

(U.S. Dollars)

Small Business Fee

(U.S. Dollars)

Annual Establishment Registration

$5,236

$5,236

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

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