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
