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

公司介绍：

深圳市思博达管理咨询有限公司是一家从事医疗器械国际咨询的专业性咨询机构。提供各个国家或地区医疗器械注册认证，包括中国NMPA、美国FDA、510(K)、欧盟MDR CE认证、加拿大MDL认证、澳洲TGA认证等等、医疗器械质量体系审查，如中国医疗器械GMP（包括试剂类）、美国QSR820质量体系场考核、欧盟GMP、日本GMP、巴西GMP、ISO13485等）等多种国际注册及认证的咨询、代理服务；也可为您提供医疗器械风险管理、软件确认、灭菌确认、临床评估、可用性确认等专题培训服务。

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) Electronic Submission Template

1、Submission Type

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

2、Cover Letter / Letters of Reference

Attach a cover letter and any documents that refer to other submissions.

3、Submitter Information

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

4、Pre-Submission Correspondence & Previous Regulator Interaction

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submission, such as submission numbers for a prior not substantially equivalent (NSE) determination, prior deleted or withdrawn 510(k), Q-Submission, Investigational Device Exemption (IDE) application, premarket approval (PMA) application, humanitarian device exemption (HDE)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

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9、Predicates and Substantial Equivalence34

Identification of a predicate device (e.g., 510(k) number, De Novo number, reclassified PMA number, classification regulation reference, if exempt and limitations to exemption are exceeded, or statement that the predicate is a preamendments device).

The submission should include a comparison of the predicate and subject device and a discussion why any differences between the subject and predicate do not impact safety and effectiveness [see section 513(i)(1)(A) of the FD&C Act and 21 CFR 807.87(f)]. A reference device should also be included in the discussion, if applicable. See “The 510(k) Program: Evaluating Substantial Equivalence in Premarket Notifications [510(k)].”

10、Design/Special Controls, Risks to Health, and Mitigation Measures

Applicable to Special 510(k) submissions only.

Identification of the device changes and the risk analysis method(s) used to assess the impact of the change(s) on the device and the results of the analysis.

Risk control measures to mitigate identified risks (e.g., labeling, verification). See “The Special 510(k) Program