美國FDA 2020年收費標準(2019.10.01到2020.09.30) @ M.D.'s Blogger

美國FDA於8月1日公告2020年醫療器材各項申請費用，依據醫療器材使用者付費(Medical Device User Fees)，新的費用生效日期從2019.10.01到2020.09.30。

年度註冊費(Annual Establishment Registration)為USD$ 5,236；小型企業( small establishments, businesses, or groups)不得豁免或減少，所有企業必須支付全額年度註冊費。

Application Type	Standard Fee (U.S. Dallars)	Small Business Fee (U.S. Dollars)
510(k)	$11,594	$2,899
513(g)	$4,603	$2,302
De Novo classification request	$102,299	$25,575
PMA, PDP, PMR, BLA	$340,995	$85,249
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
Annual Report	$11,935	$2,984
30-day notice	$5,456	$2,728