FDA 510K preparation including clinical study: Reasonable fees?
what would you say are reasonable fees for the preparation and submission of a traditional 510K for a moderate risk medical device.
The 510K preparation includes statistical analysis of clinical data + discussion of findings and report writing(clinical performance validation).
It also includes all the rest of the 510K work (SE discussion, documentation writing as needed), review/correction of the available information and so on.
I would really appreciate your comments on this