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Hi Again,
I need your help with one more thing. As I mentioned that we are submitting 510k of a class II device.
Apart from all the documents required by FDA for a traditional 510k application.
Do we also need to submit all documents (like a plan in place on how we are going to handle adverse events, servicing, training, purchasing data, quality plan, internal audit etc) that show our compliance with various requirements of 21 CFR part 820? and do we need to submit CAPA to the FDA? OR these documents should be maintained for records which will be checked by FDA in an inspection. Any help will be highly appreciated.

I need your help with one more thing. As I mentioned that we are submitting 510k of a class II device.
Apart from all the documents required by FDA for a traditional 510k application.
Do we also need to submit all documents (like a plan in place on how we are going to handle adverse events, servicing, training, purchasing data, quality plan, internal audit etc) that show our compliance with various requirements of 21 CFR part 820? and do we need to submit CAPA to the FDA? OR these documents should be maintained for records which will be checked by FDA in an inspection. Any help will be highly appreciated.
