8月29日，FDA官方网站公布2018年财年医疗器械评审*新收费情况。此收费将从今年（2017年）10月1日开始实施，到2018年9月30日截止。
其中，*具关注的FDA 510k 的标准收费从USD4690 涨价到10542 USD；
FDA 510k类中小企业收费仍然为USD2636；
详情可见此：FY 2018 Medical Device User Fee Small Business Qualification and Certification Guidance for Industry, Food and Drug Administration Staff and Foreign Governments (PDF 797KB)
工厂注册（2018年度）费用涨到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
There are no waivers or reductions for small establishments, businesses, or groups – all establishments must pay the establishment registration fee.
其中，*具关注的FDA 510k 的标准收费从USD4690 涨价到10542 USD；
FDA 510k类中小企业收费仍然为USD2636；
详情可见此：FY 2018 Medical Device User Fee Small Business Qualification and Certification Guidance for Industry, Food and Drug Administration Staff and Foreign Governments (PDF 797KB)
工厂注册（2018年度）费用涨到USD4631。
‡ 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
There are no waivers or reductions for small establishments, businesses, or groups – all establishments must pay the establishment registration fee.
|
申请类型 |
2017财年标准收费 |
2018财年标准收费 |
涨幅比例 |
|
510（k） |
$4,690 |
$10,542 |
124% |
|
小企业收费 |
$2,345 |
$2,345 |
0% |
|
513g |
$3,166 |
$4,186 |
32% |
|
小企业收费 |
$1,583 |
$2,093 |
32% |
|
De Novo classification |
Free |
$93,017 |
/ |
|
小企业收费 |
Free |
$23,254 |
/ |
|
PMA |
$234,495 |
$310,058 |
32% |
|
小企业收费 |
$58,624 |
$77,515 |
32% |
|
Annual Establishment Registration Fee |
$3,382 |
$4,631 |
37% |
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