前幾週美國FDA公告最新2013年對小型企業審查收費標準，與2012年收費標準相比，果然提高不少費用，最高差額可達到七千美元，當然更不用說，不是小型企業收費金額了，以上市前審查(Premarket Approval, PMA)為例，就可達二萬八千美元差異，因此企業送件到美國FDA的審查費用是越來越高了，以下列出，美國FDA公告2013年收費標準，供大家參考。
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Medical Device Fees for FY 2013 |
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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) |
$248,000 |
$62,000 |
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Premarket report (for a reprocessed single-use device) |
$248,000 |
$62,000 |
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Panel-track PMA supplement |
$186,000 |
$46,500 |
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BLA efficacy supplement |
$248,000 |
$62,000 |
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180-day PMA supplement |
$37,200 |
$9,300 |
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Real-time PMA supplement |
$17,360 |
$4,340 |
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510(k) premarket notification |
$4,960 |
$2,480 |
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30-day notice |
$3,968 |
$1,984 |
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513(g) request for classification information |
$3,348 |
$1,674 |
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Annual fee for periodic reporting on a class III device |
$8,680 |
$2,170 |
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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 2013, you should not submit an FY 2013 Certification. |
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Type of Fee |
Annual Fee |
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Establishment registration fee |
$2,575 |
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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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