The simplified application sounds good. Through software, cycles are reduced to one only and sterilising long scopes will be for later, in a future submission. The cycle time will be somewhat longer as a result. I do not recall the details of that. Rumble does talk about it. Users are not looking for sterilised long scopes anyway as they are used in gastro investigations. As soon as a sterile scope passes your rectum it is no longer sterile anyway. In hind sight , which is always 100% clear, this approach would have saved us many months of frustration. Three different cycles seems to have made the subsmission similar to three submissions at the same time. Reading between the lines i sensed some frustration on the part of the FDA. They have cut their own time to reply to state if the application is complete and then to study it and accept it or reject it. There seems to be a recognition on the part of the FDA that things were taking too long. In summary the KISS principal should have been applied at the start. This approach, through software, does not affect the mechanicals and will allow the future return to three (or more) cycles once the required approvals are obtained. Making submissions does cost TOS money so the FDA seems to have some consideration for its "clients" in its ambition to reduce its response times.


Please listen to the CC.