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2018年医疗类产品FDA收费标准

FDA于美国当地时间2017828日公布了2018财年(2017101–2018930)FDA各项服务的收费案,2017年内829FDA更正了部分收费金额。

 

FDA2018财年费率比2017财年大幅度提高,

FDA公司年度认证费用由原来的USD3,382提升到USD4,624,提高了37% 

FDA510K审核费标准费率由原来的USD4,690提高到USD10,566,提高了一倍以上。

 

Important Information on Medical Device User Fees for Fiscal Year 2018

(适用于FDA 2018财年:2017101日至2018930)

 

主要费率:

项目

2018财年(2017.10.01-2018.09.30)

2018财年医疗器械公司注册年度认证费

USD4,624个制造商(无减免)

2018财年FDA510(K)审核费(每个510K申请)

USD10,566 (标准收费)

USD 2,642 (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:

FY2018 User Fees for Medical Device Applications
The following table identifies the FY18 User Fees for Applications (in US Dollars)

application type

standard fee

small business fee?

510(k)?

10,566

2,642

513(g)

4,195

2,098

de novo classification

93,229

23,307

PMA, PDP, PMR, BLA

310,764

77,691

panel-track supplement

233,073

58,268

180-day supplement

46,615

11,654

real-time supplement

21,753

5,438

BLA efficacy supplement

310,764

77,691

annual report

10,877

2,719

30-day notice

4,972

2,486

?  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 by an FDA-accredited third-party reviewer.

 

ZCQC将从201710月开始为客人进行2018年度认证和受理新认证申请。

 

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