涨价幅度超过120%，2018财年美国FDA 审评收费

Miyabi

2017年8月28日，FDA公布2018财年医疗器械评审最新收费情况。相比2017财年，其最高涨幅超过120%。其中510k、513g、De Novo, PMA申请及企业注册年费对比如下：

申请类型	2017财年标准收费	2018财年标准收费	涨幅比例
510(k)	$4,690	$10,566	125%
小企业收费	$2,345	$2,642	12.7%
513g	$3,166	$4,195	32.5%
小企业收费	$1,583	$2,098	32.5%
De Novo classification	Free	$93,229	/
小企业收费	Free	$23,307	/
PMA	$234,495	$310,764	32.5%
小企业收费	$58,624	$77,691	32.5%
Annual Establishment Registration Fee	$3,382	$4,624	36.7%

2018财年FDA医疗器械审评费

申请类型	标准收费	小企业收费
510(k)	$10,566	$2,642
513g	$4,195	$2,098
De Novo classification	$93,229	$23,307
PMA, PDP, PMR, BLA	$310,764	$77,691
panel-track supplement	$232,073	$58,268
180-day supplement	$46,615	$11,654
real-time supplement	$21,753	$5,438
BLA efficacy supplement	$310,764	$77,691
PMA annual report	$10,877	$2,719
30-day notice	$4,972	$2,486
Annual Establishment Registration Fee	$4,624

同花顺

学习了。。。不错。

Miyabi

同花顺 发表于 2017-9-8
学习了。。。不错。

谢谢您~共同学习吧~