全国 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

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