发布时间:2014-07-31
更新日期:
FDA公布2015财年收费案
来源:FDA
FDA于美国当地时间
Important Information on the Medical Device User Fee Rates for FY2015
(适用于FDA 2015财年:
主要费率:
项目 |
2015财年(2014.10.01-2015.09.30) |
2015财年医疗器械制造商年度认证费 |
USD3,646/个制造商 |
2015财年FDA510(K)审核费 |
USD5,018/个510(K)申请 |
FDA网站相关链接:
http://www.gpo.gov/fdsys/pkg/FR-
FY2015 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 |
30-day notice |
$4,014 |
$2,007 |
The schedule of annual registration user fees for fiscal years 2013 through 2017 follows:
Year |
FY 2013 |
FY 2014 |
FY 2015 |
FY 2016 |
FY 2017 |
Fee |
$2,575 |
$3,313 |
$3,646 |
$3,872 |
$3,872 |
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http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/HowtoMarketYourDevice/RegistrationandListing/default.htm