美国 510 K 提交内容

1、Submission Type

2、Cover Letter / Letters of Reference

3、Submitter Information

4、Pre-Submission Correspondence & Previous Regulator Interaction

5、Consensus Standards

6、Device Description

7、Proposed Indications for Use (Form FDA 3881

8、Classification

9、Predicates and Substantial Equivalence34

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

11、Labeling

12、Reprocessing

13、Sterility

14、Shelf Life

15、Biocompatibility

16、Software/Firmware

17、Cybersecurity/Interoperability

18、Electromagnetic Compatibility (EMC), Electrical, Mechanical, Wireless and Thermal Safety

19、Performance Testing

20、References

21、Administrative Documentation

22、Amendment/Additional Information (AI) response

深圳思博达医疗技术服务有限公司凭借500余个医疗器械注册认证成功案例经验，为国内外医疗器械公司，科研机构、个人提供二、三类医疗器械注册证办理，二、三类医疗器械生产许可证办理，二类器械经营备案证、三类器械经营许可证办理，注册人研发、委托生产、一类产品备案证、一类产品生产备案证、产品注册检验、临床试验CRO、医疗器械质量体系GMP现场考核、ISO13485质量管理体系、、软件管理，三品一械（食品、药品、化妆品、医疗器械）法规标准培训、CE和FDA等“一站式”服务等等。