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FDA官方最新公布2018年相關(guān)醫療產(chǎn)品財年標準收費 Time:2017-08-30 09:32:44    瀏覽數量:4864次   

    8月29日,FDA官方網(wǎng)站公布2018年財年醫療器械評審最新收費情況。此收費將從今年(2017年)10月1日開(kāi)始實(shí)施,到2018年9月30日截止。

1.其中,最具關(guān)注的FDA 510k 的標準收費從USD4690 漲價(jià)到10542 USD;

2.FDA 510k類(lèi)中小企業(yè)收費仍然為USD2636;

詳情可見(jiàn)此:FY 2018 Medical Device User Fee Small Business Qualification and Certification - Guidance for Industry, Food and Drug Administration Staff and Foreign Governments (PDF - 797KB)

3.工廠(chǎng)注冊(2018年度)費用漲到USD4631。


?For small businesses with an approved SBD.

? Note: all types of 510(k)s (Traditional, Abbreviated, and Special) are subject to the user fee. However, there is no user fee for 510(k)s submitted to the FDA on behalf of an FDA-accredited third-party reviewer.

Small businesses with an approved SBD with gross receipts or sales of $30 million or less are eligible to have the fee waived on their first PMA, PDP, PMR, or BLA.

Annual Establishment Registration Fee: $4,631


申請類(lèi)型

2017財年標準收費

2018財年標準收費

漲幅比例

510(k)

$4,690

$10,542

124%

小企業(yè)收費

$2,345

$2,345

0%

513g

$3,166

$4,186

32%

小企業(yè)收費

$1,583

$2,093

32%

De Novo classification

Free

$93,017

/

小企業(yè)收費

Free

$23,254

/

PMA

$234,495

$310,058

32%

小企業(yè)收費

$58,624

$77,515

32%

Annual Establishment Registration Fee

$3,382

$4,631

37%

 

  There are no waivers or reductions for small establishments, businesses, or groups – all establishments must pay the establishment registration fee.


全文詳情可見(jiàn)FDA官方網(wǎng)站:FY 2018 MDUFA User Fees


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