FDA公布2015财年医疗器械收费标准,企业年费上浮到USD3,646_进口医疗器械注册_国产医疗器械注册_一二三类医疗器械产品注册备案专业代办外包公司|道和思源
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FDA公布2015财年医疗器械收费标准,企业年费上浮到USD3,646

发布日期:2020-05-09 浏览次数:

附:FDA 2015财年医疗器械全部收费标准如下
 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

 

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