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FDA 510 提交的内容



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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