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FDA公布2014财年收费案
发布时间:2013-08-28

FDA公布2014财年收费案

 

来源:FDA

 

FDA201382公布了2014财年(2013101 2014930)的收费案,

 

Important Information on the Medical Device User Fee Rates for FY2014

(适用于FDA 2014财年:20131012014930)

 

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

USD5,170/510(K)申请

 

FDA网站相关链接:

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

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.

 

IRC将从2013101开始按照该费率为所有中国客人进行2014年度认证。

 

IRC编译整理

www.FDAChina.com