附:FDA 2015財年醫療器械全部收費標準如下

 

The annual establishment registration fee must be paid between October 1, 2014 and December 31, 2014. For FY15, the registration fee for each establishment is $3,646 (in U.S. Dollars). All establishments are required to pay the establishment registration fee.

2105FY15 User Fees (in U.S. Dollars)

application type

standard fee

small business fee?

510(k)?

$5,018

$2,509

513(g)

$3,387

$1,694

PMA, PDP, PMR, BLA

$250,895

$62,724

panel-track supplement

$188,171

$47,043

180-day supplement

$37,634

$9,409

real-time supplement

$17,563

$4,391

BLA efficacy supplement

$250,895

$62,724

annual report

$8,781

$2,195

30-day notice

$4,014

$2,007