I will be submitting a 510K shortly. Is there any necessity (or point for that matter) in contacting the fda via phone to let them know a submission is imminent. We do not qualify for any of the special pre-meetings (ie no clinical trial, no novel design/material) and their telephone guidelines seem to want to limit telephone contact as much as possible. At the submission stage the reviewer will not yet have been assigned. There has been a lot of buzz about contacting FDA early and often. I have only ever looked at this in the light of PMAs, HDEs etc but not 510Ks but there is some expectation from upper management that some sort of conversation will take place. Can anyone who has been through this process recently weigh in here. I would really appreciate it?