I have wrote to FDA for help. Here is the content and i hope more discussion.
...................................................................................................
"Dear Celia:
The risk analysis should really account for the whole device after the modifications have been made. If the risk analysis shows "no risk," then you would not need to submit design validation and verification. I hope this is helpful.
------------------------------------------------------------------------------------------------------------------------
Hi:
We have met problem as follows, when submitting the special 510(k)
" [FONT=宋]The information you have provided on your design control activities is not sufficiently detailed. Therefore, please provide a more specific and detailed information on your design control activities.
[FONT=宋]
[/FONT]
[FONT=宋] A An identification of risk analysis methods used to assess the impact of the modification on the device and its components.
[/FONT]
[FONT=宋]
[/FONT]
[FONT=宋] B The results of the risk analysis, e.g.,the specification, and whether the device passed or failed.
[/FONT]
[FONT=宋]
[/FONT]
[FONT=宋] C Based on the risk analysis, an identification of:
[/FONT]
[FONT=宋] [/FONT][FONT=宋]ⅰ the required verification and validation activies, including the methods or tests used, and
[/FONT]
[FONT=宋] [/FONT][FONT=宋]ⅱ the acceptance criteria to be applied.
[/FONT]
[FONT=宋] D A declaration of conformity with design controls. [/FONT][FONT=宋][/FONT]
[FONT=宋]The question are: the risk analysis should be on the whole device, or just on the changed part of the medical device? If the result of the risk analysis shows that no risk should be controlled, Do we need to submit the design verification and the design validation? [/FONT]
[FONT=宋] celia [/FONT]
[FONT=宋]
[/FONT] ..........................................................................................................................[/FONT]