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FDA发布2021年医疗器械年费为USD5,546

787
发表时间:2017-09-04 00:00

FDA公布2021财年收费

FDA于美国当地时间202083日公布了2021财年(2020101 – 2021930)FDA各项服务的收费案。

FDA2021财年费率比2020财年收费微涨,FDA公司年度认证费用由2020财年的USD5236提升到2021财年的USD5,546 FDA510K审核费标准费率由原来的USD11594提高到USD12432(小企业费率同步提高)

Important Information on Medical Device User Fees for Fiscal Year 2021

(适用于FDA 2021财年:2020101日至2021930)

主要费率:

项目

2020财年(2019.10.01-2020.09.30)

2021财年(2020.10.01-2021.09.30)

医疗器械公司注册年度认证费

USD5,236个制造商(无减免)

USD5,546个制造商(无减免)

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)

USD12,432 (标准收费)

USD 3,108 (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. In addition, if a small business has gross receipts or sales of $30 million or less, it is eligible to have the fee waived for its first PMA, PDP, PMR or BLA.

其他费率:

FY 2021 MDUFA User Fees

The Fees for Fiscal Year 2021 (October 1, 2020 through September 30, 2021) are as follows:

Application Type

Standard Fee

Small Business Fee†

510(k)‡

$12,432

$3,108

513(g)

$4,936

$2,468

PMA, PDP, PMR, BLA

$365,657

$91,414

De Novo Classification Request

$109,697

$27,424

Panel-track Supplement

$274,243

$68,561

180-Day Supplement

$54,849

$13,712

Real-Time Supplement

$25,596

$6,399

BLA Efficacy Supplement

$365,657

$91,414

30-Day Notice

$5,851

$2,926

Annual Fee for Periodic
Reporting on a Class III device
(PMAs, PDPs, and PMRs)

$12,798

$3,200

† 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: $5,546

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

FDA网站相关链接:

https://www.fda.gov/industry/fda-user-fee-programs/medical-device-user-fee-amendments-mdufa

FDA2021财年小企业资格申请程序指南:

FY 2021 Medical 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

OUA将从202010月开始按照该费率为所有客人进行2021年度认证和受理新认证申请。


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