最新消息
2018 / 12 / 17
FDA 公佈 2019 年醫療器材和學名藥
送件收費標準
美國FDA於8月1日公告 2019 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 2018.10.01 到 2019.09.30。
年度註冊費 (Annual Establishment Registration)為 USD$ 4,884；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. Dollars) | Small Business Fee (U.S. Dollars) |
|---|---|---|
| Annual Establishment Registration | $4,884 | $4,884 |
| 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 |
