发布时间：2013-08-28
FDA公布2014财年收费案
来源：FDA
FDA于
Important Information on the Medical Device User Fee Rates for FY2014
(适用于FDA 2014财年：
主要费率：
|
项目 |
2014财年(2013.10.01-2014.09.30) |
|
医疗器械制造商年度认证费 |
USD3,313/个制造商 |
|
FDA510(K)审核费 |
USD5,170/个510(K)申请 |
FDA网站相关链接：
|
Year |
FY 2013 |
FY 2014 |
FY 2015 |
FY 2016 |
FY 2017 |
|
Fee |
$2,575 |
$3,313 |
$3,750 |
$3,872 |
$3,872 |
http://www.gpo.gov/fdsys/pkg/FR-2013-08-02/html/2013-18623.htm
FY14 User Fees for Applications
The following table identifies the FY14 User Fees for Applications.
FY14 User Fees (in U.S. Dollars)
|
application type |
standard fee |
small business fee† |
|
510(k)‡ |
$5,170 |
$2,585 |
|
513(g) |
$3,490 |
$1,745 |
|
PMA, PDP, PMR, BLA |
$258,520 |
$64,630 |
|
panel-track supplement |
$193,890 |
$48,473 |
|
180-day supplement |
$38,778 |
$9,695 |
|
real-time supplement |
$18,096 |
$4,524 |
|
BLA efficacy supplement |
$258,520 |
$64,630 |
|
annual report |
$9,048 |
$2,262 |
|
30-day notice |
$4,136 |
$2,068 |
† For small businesses with an approved SBD.
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