FDA于美国当地时间2017年8月28日公布了2018财年(2017年10月1日–2018年9月30日)的FDA各项服务的收费情况,2017年内8月29日FDA更正了部分收费金额。
FDA 2018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%; FDA 510K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 2017
(适用于FDA 2018财年:2017年10月1日至2018年9月30日)
主要费率:
项目
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2018财年(2017.10.01-2018.09.30)
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2018财年医疗器械公司注册年度认证费
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USD4,624个制造商(无减免)
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2018财年FDA510(K)审核费(每个510K申请)
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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)
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* 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
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standard fee
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small business fee†
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510(k)‡
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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
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21,753
|
5,438
|
BLA efficacy supplement
|
310,764
|
77,691
|
annual report
|
10,877
|
2,719
|
30-day notice
|
4,972
|
2,486
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† 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.
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