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FDA公布2017财年收费案
发布时间:2016-08-02

更新日期:2016-08-02

 

FDA公布2017财年收费案

 

来源:FDA

 

FDA于美国当地时间2016729公布了2017财年(2016101 – 2017930)FDA各项服务的收费案,

 

Important Information on Medical Device User Fees for Fiscal Year 2017

(适用于FDA 2017财年:20161012017930)

 

主要费率:

项目

2017财年(2016.10.01-2017.09.30)

2017财年医疗器械制造商年度认证费

USD3,382个制造商

2017财年FDA510(K)审核费

USD4,690/510(K)申请

(针对获批小企业资格减半收取)

 

FDA网站相关链接:

https://www.gpo.gov/fdsys/pkg/FR-2016-07-29/html/2016-17903.htm?source=govdelivery&utm_medium=email&utm_source=govdelivery

 

FY17 User Fees for Medical Device Applications The following table identifies the FY17 User Fees for Applications (in US Dollars)

application type

standard fee

small business fee?

510(k)?

4,690

2,345

513(g)

3,166

1,583

PMA, PDP, PMR, BLA

234,495

58,624

panel-track supplement

175,871

43,968

180-day supplement

35,174

8,794

real-time supplement

16,415

4,104

BLA efficacy supplement

234,240

58,560

annual report

8,207

2,052

30-day notice

3,752

1,876

?  For small businesses with an approved SBD.

?  Note:  all types of 510(k)s (Traditional, Abbreviated, and Special) are subject to the user fee.  However, there is no user fee for 510(k)s submitted to the FDA by an FDA-accredited third-party reviewer.

The FY17 user fees apply to medical device applications received by the FDA on or after October 1, 2016.  If you wish to pay the FY16 user fee for an application, both your application and your user fee payment must be received prior to October 1, 2016.

 

 

 

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

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

$3,382

 

FDA2017财年小企业资格申请程序指南:

FY 2017 Medical Device User Fee Small Business Qualification and Certification Guidance.

http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/UCM514085.pdf?source=govdelivery&utm_medium=email&utm_source=govdelivery

 

 

IRC将从2016101开始按照该费率为所有中国客人进行2017年度认证和受理新认证申请。

 

IRC编译整理

www.FDAChina.com