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 FY2027 (in U.S. Dollars)-----2026.10.01~2027.09.30
| Application Type | Standard Fee | Small Business Fee† |
|---|---|---|
| 510(k)‡ | $28,653 | $7,163 |
| 513(g) | $8,596 | $4,298 |
| PMA, PDP, PMR, BLA | $636,732 | $159,183 |
| De Novo Classification Request | $191,020 | $47,755 |
| Panel-track Supplement | $509,386 | $127,347 |
| 180-Day Supplement | $95,510 | $23,878 |
| Real-Time Supplement | $44,571 | $11,143 |
| BLA Efficacy Supplement | $636,732 | $159,183 |
| 30-Day Notice | $10,188 | $5,094 |
| Annual Fee for Periodic Reporting on a Class III device (PMAs, PDPs, and PMRs) | $22,286 | $5,572 |
※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.
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