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关于美国FDA2019财年医疗器械收费的通知

各医疗器械生产企业:

美国FDA201881日发布了《2019财年医疗器械收费标准》和《2019财年医疗器械小企业资质和认证指南》。
若贵公司产品已在美国上市或计划申请上市准入,请多加关注。

2019财年医疗器械收费标准》←请点击链接查看详情

2019财年医疗器械小企业资质和认证指南》←请点击链接查看详情
 
国内企业应符合:章节V. Guidance for Foreign Businesses
2019
财年自2018101日至2019930日。
 

FY 2019 User Fees (in U.S. Dollars)

Application Type

Standard Fee

Small Business Fee

510(k)

$10,953

$2,738

513(g)

$4,349

$2,175

De Novo classification

$96,644

$24,161

PMA, PDP, PMR, BLA

$322,147

$80,537

panel-track supplement

$241,610

$60,403

180-day supplement

$48,322

$12,081

real-time supplement

$22,550

$5,638

BLA efficacy supplement

$322,147

$80,537

Annual Report

$11,275

$2,819

30-day notice

$5,154

$2,577

† 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: $4,884

                                                                                            
深圳市医疗器械行业协会

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