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FDA公布2015财年收费案
发布时间:2014-07-31

更新日期:2014-07-31

 

FDA公布2015财年收费案

 

来源:FDA

 

FDA于美国当地时间2014730公布了2015财年(2014101 2015930)的收费案,

 

Important Information on the Medical Device User Fee Rates for FY2015

(适用于FDA 2015财年:20141012015930)

 

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

USD5,018/510(K)申请

 

FDA网站相关链接:

http://www.gpo.gov/fdsys/pkg/FR-2014-07-30/html/2014-17902.htm?source=govdelivery&utm_medium=email&utm_source=govdelivery

 

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

 

IRC将从2014101开始按照该费率为所有中国客人进行2015年度认证。

 

IRC编译整理

www.FDAChina.com

 

 

 

http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/HowtoMarketYourDevice/RegistrationandListing/default.htm