发布时间:2018-08-01
FDA公布2019财年收费案
来源:FDA
FDA于美国当地时间2018年7月30日公布了2019财年(2018年10月1日 – 2019年9月30日)的FDA各项服务的收费案。
FDA2019财年费率比2018财年收费微涨,FDA公司年度认证费用由2018财年的USD4,624提升到2019财年的USD4,884; FDA510K审核费标准费率由原来的USD10,542提高到USD10,953。
Important Information on Medical Device User Fees for Fiscal Year 2019
(适用于FDA 2019财年:2018年10月1日至2019年9月30日)
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
IRC将从2018年10月开始按照该费率为所有中国客人进行2019年度认证和受理新认证申请。
IRC编译整理
www.FDAChina.com