FDA 2019年年费又双叒叕涨价了!!!
来源:    发布时间: 2018-08-21 09:21   4838 次浏览   大小:  16px  14px  12px


近日,上海曼通从美国FDA获得最新消息,FDA 公布了2019财年医疗器械收费标准,企业年费较2018年的USD4,624有小幅的上涨,为USD4,884。所有国内的医疗器械生产型和贸易型企业均需要交纳此费用。

下图上海曼通统计的,2008年以来FDA开始收取医疗器械年费的历年标准。可以看到,从2008年的USD1,706一直涨到2019年的USD4,884。为数不少的低附加值中小型出口医疗器械企业生存压力日益增大。

上海曼通将从10月1日起为中国用户提供FDA医疗器械注册更新服务。



FDA于美国当地时间2018730日公布了2019财年(2018101 – 2019930)FDA各项服务的收费案。

Important Information on Medical Device User Fees for Fiscal Year 2019

(适用于FDA 2019财年:2018101日至2019930)

 主要费率:

项目

2019财年(2018.10.01-2019.09.30)

2019财年医疗器械公司注册年度认证费

USD4,884个制造商(无减免)

2019财年FDA510(K)审核费(每个510K申请)

USD10,953 (标准收费)

USD 2,738(FDA认证为小企业资质的公司享受该费率)

* FDA小企业资质指的是公司最近税收年度的总收入或销售额未超过1亿美金,并需要提前1-2个月申请FDA小企业资质认证后才能享受优惠;

Small Business: This is defined as having gross receipts or sales of no more than $100 million for the most recent tax year. 




其他费率:

FY19 User Fees for Medical Device Submissions
The following table identifies the FY19 User Fees for Medical Device Submissions (in U.S. dollars).

Application Type

Standard Fee

Small Business Fee†

510(k)‡

10,953

2,738

513(g)

4,349

2,175

PMA, PDP, PMR, BLA

322,147

80,537

De Novo classification request

96,644

24,161

panel-track supplement

241,610

60,403

180-day supplement

48,322

12,081

real-time supplement

22,550

5,638

BLA efficacy supplement

322,147

80,537

annual report

11,275

2,819

30-day notice

5,154

2,577

  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 by an FDA-accredited Third- Party Reviewer to the FDA.

FDA网站相关链接:

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

 

https://www.federalregister.gov/documents/2018/07/30/2018-16178/medical-device-user-fee-rates-for-fiscal-year-2019?utm_campaign=Important%20Information%20on%20Medical%20Device%20User%20Fees%20for%20Fiscal%20Year%202019&utm_medium=email&utm_source=Eloqua&elqTrackId=BA45F46A76F830A02FF0D8A0D0D90433&elq=c1ddef6300864931b426de5a9dece861&elqaid=4441&elqat=1&elqCampaignId=3531

 

 

FDA2019财年小企业资格申请程序指南:

FY 2019Medical Device User Fee Small Business Qualification and Certification Guidance.

https://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/UCM456779.pdf?utm_campaign=Important%20Information%20on%20Medical%20Device%20User%20Fees%20for%20Fiscal%20Year%202019&utm_medium=email&utm_source=Eloqua&elqTrackId=640B14BE8C79E23BD5DA5C5796947FF4&elq=c1ddef6300864931b426de5a9dece861&elqaid=4441&elqat=1&elqCampaignId=3531