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
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