重磅！FDA公布2018财年收费标准，费用大涨！

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近日，FDA发布了2018财年最新收费标准。

药品方面

医疗器械方面

510(k)收费大涨124%，中小企业（年收入小于1亿美元）收费涨32%，工厂注册年费涨幅37%，中低风险创新器械De Novo新增审核费23254美元（之前为免费）。

以下为FDA官网原文：

FY 2018 MDUFA User Fees

The Fees for Fiscal Year 2018 (October 1, 2017 through September 30, 2018) are as follows:

FY 18 User Fees (in U.S. Dollars)

Application Type	Standard Fee	Small Business Fee†
510(k)‡	$10,542	$2,636
513(g)	$4,186	$2,093
De Novo classification	$93,017	$23,254
PMA, PDP, PMR, BLA	$310,058	$77,515
panel-track supplement	$232,544	$58,156
180-day supplement	$46,509	$11,627
real-time supplement	$21,704	$5,426
BLA efficacy supplement	$310,058	$77,515
PMA annual report	$10,852	$2,713
30-day notice	$4,961	$2,481

† 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.

Additional Information about MDUFA III Fees

• FY 2018 Medical Device User Fee Small Business Qualification and Certification - Guidance for Industry, Food and Drug Administration Staff and Foreign Governments (PDF - 797KB)

• Medical Device User Fees

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【来源】FDA、医疗人咖啡

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