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)
† 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
【来源】FDA、医疗人咖啡 【全文转载及整理】奥咨达 |