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FDA官方最新颁布2018年有关医疗产品财年尺度收费 Time：2017-08-29 16:03:54    浏览数量：8241次   

　　8月29日，FDA官方网站颁布2018年财年医疗器械评审最新收费情况。此收费将从今年（2017年）10月1日起头执行，到2018年9月30日截止。
　　其中，最具关注的FDA 510k 的尺度收费从USD4690 涨价到10542 USD；
　　FDA 510k类中幼企业收费依然为USD2636；
　　详情可见此：FY 2018 Medical Device User Fee Small Business Qualification and Certification - Guidance for Industry, Food and Drug Administration Staff and Foreign Governments (PDF - 797KB)
　　工厂注册（2018年度）用度涨到USD4631。

yth2206游艇会·(中国区)官方网站

　　?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: $4,631
　　There are no waivers or reductions for small establishments, businesses, or groups – all establishments must pay the establishment registration fee.

申请类型

2017财年尺度收费

2018财年尺度收费

涨幅比例

510（k）

$4,690

$10,542

124%

幼企业收费

$2,345

$2,345

0%

513g

$3,166

$4,186

32%

幼企业收费

$1,583

$2,093

32%

De Novo classification

Free

$93,017

/

幼企业收费

Free

$23,254

/

PMA

$234,495

$310,058

32%

幼企业收费

$58,624

$77,515

32%

Annual Establishment Registration Fee

$3,382

$4,631

37%


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