8月29日，FDA官方網站公布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日開始實施，到2018年9月30日截止。
1．其中，最具關注的FDA 510k 的標準收費從USD4690 漲價到10542 USD；
2．FDA 510k類中小企業收費仍然為USD2636；
詳情可見此：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%
|
|
小企業收費
|
$2,345
|
$2,345
|
0%
|
|
513g
|
$3,166
|
$4,186
|
32%
|
|
小企業收費
|
$1,583
|
$2,093
|
32%
|
|
De Novo classification
|
Free
|
$93,017
|
/
|
|
小企業收費
|
Free
|
$23,254
|
/
|
|
PMA
|
$234,495
|
$310,058
|
32%
|
|
小企業收費
|
$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FDA官方網站：FY 2018 MDUFA User Fees
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