所謂FDA 510(k)即是指上市前通知【Premarket
Notification，或簡稱510(k)】，此途徑適用於仿造「市場上現存合格 Legally marketed」，或於西元1976年前即已上市之第一類及第二類產品之新器材。此類新器材包括相同用途之全新器材、或是同樣不同公司銷售之器材、以及經過改良之相似器材。
由於此新產品是仿照現有之合格產品，在510(k)之申請時，必須對其設計、材料、製造過程、功效性及用途等，與已上市之舊產品(也即所謂Predicate Device)做一比較。以裁定此新產品是否與舊產品具「實質相等性（Substantial Equivalence）」。
Medical Device User Fees for FY2018 (in U.S. Dollars)
Application Type
Oct 1, 2017 through
Sept. 30, 2018
Standard fee
Small business fee
510(k)
$10,566
$2,642
513(g)
$4,195
$2,098
De Novo classification
$93,229
$23,307
PMA, PDP, PMR, BLA
$310,764
$77,691
panel-track supplement
$233,073
$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
※此內容僅供參考，實際費用以FDA公告為主。
註1：FDA於每年10月1日前會公佈下一年度申請費用。
註2：Small Business (小型企業)：指年營業額在US$100 million以下之公司。
註3：Small businesses with an
approved SBD with gross receipts or sales of US$30 million or less are eligible
to have the fee waived on their first PMA, PDP, PMR or BLA.
版權所有，盜用必究