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

更多美国FDA医疗器械产品注册备案常见问题及方案解决请联系深圳市思博达彭先生或登录公司网站www.bccgd.com。