看到美国FDA发布的2020财年的收费标准，确实有种压力山大的感觉，甚至有种感觉，就是美国佬在抢钱，仅仅一个管理费，要收5236美金，4万多块人民币，比2019年，涨了37%了，出口商利润越来越薄，FDA收费越来越高，进一步再压榨出口商的利润。下面是FDA发布的2020财年的收费标准，各种收费标准：

FDA于美国当地时间2017年8月28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，2019年内8月29日FDA更正了部分收费金额。
 

FDA2020财年费率比2019财年大幅度提高，FDA公司年度认证费用由原来的USD4884提升到USD5236，提高了37%； FDA510K审核费标准费率由原来的USD10566提高到USD10,593，提高了一点点。
 

Important Information on Medical Device User Fees for Fiscal Year 2017
(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

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