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FDA公布2020财年收费案
发布时间：2019年8月8日

FDA公布2020财年收费案

来源：FDA

FDA于美国当地时间2019年7月31日公布了2020财年(2019年10月1日 – 2020年9月30日)的FDA各项服务的收费案。

FDA2020财年费率比2019财年收费微涨，FDA公司年度认证费用由2019财年的USD4,884提升到2020财年的USD5,236； FDA510K审核费标准费率由原来的USD10,953提高到USD11,594。

Important Information on Medical Device User Fees for Fiscal Year 2019

(适用于FDA 2020财年：2019年10月1日至2020年9月30日)

主要费率：

项目

2020财年(2019.10.01-2020.09.30)

2019财年(2018.10.01-2019.09.30)

2020财年医疗器械公司注册年度认证费

USD5,236个制造商(无减免)

USD4,884个制造商(无减免)

2020财年FDA510(K)审核费(每个510K申请)

USD11,594 (标准收费)

USD2,899 (FDA认证为小企业资质的公司享受该优惠收费)

USD10,953 (标准收费)

USD 2,738 (FDA认证为小企业资质的公司享受该优惠收费)

* 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：

FY 2020 MDUFA User Fees

The Fees for Fiscal Year 2020 (October 1, 2019 through September 30, 2020) are as follows:

Application Type	Standard Fee	Small Business Fee†
510(k)‡	$11,594	$2,899
513(g)	$4,603	$2,302
PMA, PDP, PMR, BLA	$340,995	$85,249
De Novo Classification Request	$102,299	$25,575
Panel-track Supplement	$255,747	$63,937
180-Day Supplement	$51,149	$12,787
Real-Time Supplement	$23,870	$5,968
BLA Efficacy Supplement	$340,995	$85,249
30-Day Notice	$5,456	$2,728
Annual Fee for Periodic Reporting on a Class III device (PMAs, PDPs, and PMRs)	$11,935	$2,984

† 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 on behalf of an FDA-accredited third-party reviewer.

Small businesses with an approved SBD with gross receipts or sales of $30 million or less are eligible to have the fee waived on their first PMA, PDP, PMR, or BLA.

Annual Establishment Registration Fee: $5,236.

There are no waivers or reductions for small establishments, businesses, or groups – all establishments must pay the establishment registration fee

https://www.federalregister.gov/documents/2019/07/31/2019-16270/medical-device-user-fee-rates-for-fiscal-year-2020?utm_campaign=2019-08-05%20Medical%20Device%20User%20Fees%20for%20Fiscal%20Year%202020&utm_medium=email&utm_source=Eloqua

FDA2020财年小企业资格申请程序指南:

FY 2020Medical Device User Fee Small Business Qualification and Certification Guidance.

https://www.fda.gov/regulatory-information/search-fda-guidance-documents/medical-device-user-fee-small-business-qualification-and-certification

IRC将从2019年10月开始按照该费率为所有客人进行2020年度认证和受理新认证申请。

IRC编译整理

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