申請類型

標(biāo)準(zhǔn)收費(fèi)

小企業(yè)收費(fèi)

510(k)

$12,432

$3,108

513g

$4,936

$2,468

De Novo classification

$109,697

$27,424

PMA, PDP, PMR, BLA

$365,657

$91,414

panel-track supplement

$274,243

$68,561

180-day supplement

$54,849

$13,712

real-time supplement

$25,596

$6,399

BLA efficacy supplement

$365,657

$91,414

PMA annual report

$12,798

$3,200

30-day notice

$5,851

$2,926

Annual Establishment Registration Fee

$5,546