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FDA公布2017财年费率

对于从2006年10月1日到2007年9月30日FDA收到的FDA510(K)申请，FDA公布了新的评审收费，USD4158/每一份 FDA5109K)论证报告；比上一个财政年度的收费USD3833增长了USD325;该收费不适用于通过第三方进行的评估项目。下面是FDA公告的原 文：

Fees

The review fees for 510(k) submissions are below:

Please note that the definition of a small business for FY2006 has changed to firms with annual gross sales or receipts of $100 million or less, including the gross sales and receipts of all affiliates, partners, and parent firms.

The applicable fee corresponds with the date of receipt of the submission by FDA. Please note that FDA will consider the 510(k) submission incomplete and will not accept it for filing until the fee is paid in full. That is, the date of receipt is the date that the submission has been received AND the fee is paid in full.

FDA will adjust these fees each year to account for inflation, changes in workloads, and other factors. The small business fee is 80% of the standard fee. FDA will announce the new fees for the next fiscal year in a Federal Register notice by August 1 of each year.

IRC编译整理

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