深圳 美国2024FDA 年度注册成本和510（K）评审费是多少，怎么申报和支付

2024 FDA 年度注册费7653$， 无优惠和减免， 510（K）技术审评费 小规模5440$, 相比2023分别递增17.87% 和9.52%！

2023 FDA 年度注册费6493$， 无优惠和减免，510（K）技术审评费 小规模4967$，相比2022 分别递增14.47% 和55.90%！

2022 FDA 年度注册费5672$， 无优惠和减免，510（K）技术审评费 小规模3186$

两个费用，年年递增，需要申请美国FDA医疗器械产品注册和备案和朋友，请联系深圳市思博达彭先生或登录公司网站www.bccgd.com。

赠送510K电子递交申报格式部分内容供参考，更多更详细的请联系深圳市思博达彭先生或登录公司网站www.bccgd.com。

Structure of the current eSTAR 510(k) ElectronicSubmission Template

1、Submission Type

Identification of key information that may beuseful to FDA in the initial processing and review of the 510(k)submission, including content from current Form FDA 3514, SectionA.

2、Cover Letter / Letters of Reference

Attach a cover letter and any documents thatrefer to other submissions.

3、Submitter Information

Information on submitter and correspondent, ifapplicable, consistent with content from current Form FDA 3514,Sections B and C.

4、Pre-Submission Correspondence & PreviousRegulator Interaction

Information on prior submissions for the samedevice included in the current submission, such as submissionnumbers for a prior not substantially equivalent (NSE)determination, prior deleted or withdrawn 510(k), Q-Submission,Investigational Device Exemption (IDE) application, premarketapproval (PMA) application, humanitarian device exemption (HDE)application, or De Novo classification request.