美國FDA於八月初公告2014年對小型企業(Small Business)收費標準，公告內容與2013年無太大差異，僅針對收費標準做了修正，每項申請費用都提高不少。
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Medical Device Fees for FY 2014 |
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Fees Relating to Medical Device Applications |
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Application Type |
Standard Fee |
Small Business |
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Premarket Application (PMA, BLA, PDP) |
$258,520 |
$64,630 |
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Premarket report (for a reprocessed single-use device) |
$258,520 |
$64,630 |
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Panel-track PMA supplement |
$193,890 |
$48,473 |
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BLA efficacy supplement |
$258,520 |
$64,630 |
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180-day PMA supplement |
$38,778 |
$9,695 |
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Real-time PMA supplement |
$18,096 |
$4,524 |
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510(k) premarket notification |
$5,170 |
$2,585 |
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30-day notice |
$4,136 |
$2,068 |
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513(g) request for classification information |
$3,490 |
$1,745 |
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Annual fee for periodic reporting on a class III device |
$9,048 |
$2,262 |
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Establishment Registration Fee — There is no reduced fee for a small business. If this is the only fee you expect to pay during FY 2014, do not submit an FY 2014 Small Business Qualification and Certification request. |
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Type of Fee |
Annual Fee |
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Establishment registration fee |
$3,313 |
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參考資料：
美國食品藥物管理局 http://www.fda.gov/
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