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2016年7月29日公布了2017财年(2016年10月1日 – 2017年9月30日)的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:2016年10月1日至2017年9月30日)
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/个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.
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2016年10月1日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