1、Submission Type
2、Cover Letter / Letters of Reference
3、Submitter Information
4、Pre-Submission Correspondence & Previous RegulatorInteraction
5、Consensus Standards
6、Device Description
7、Proposed Indications for Use (Form FDA3881
8、Classification
9、Predicates and SubstantialEquivalence34
10、Design/Special Controls, Risks to Health, andMitigation 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
