Hi
@MyBentley,
I would have to strongly disagree.
Seriously, did RAP need to go through all this drama to discover that the App didn't deliver in certain conditions?
I have only read a fraction of the all the posts here as there are well over a thousand posts since last Wednesday. But it quickly becomes clear that many lives have been hurt; one family collectively down $600k+, another young guy down $30k after borrowing from his mum. Where is the blessing in that for these people?
It is great to be able to see the bright side of things, but within reason: when you are getting your arm cut off, it isn't helpful to marvel at the blessing of retaining one good arm.
It is responsible to go into damage control and keep the knife wielders at bay. Every holder wants to be assured that they won't get smashed again in the second round.
As for the 'quiet room', how would you quantify quiet? If such a special room is a prerequisite there it needs to be a specified standard. It will undoubtably be a question that the FDA will ask if you wanted to take it down that path. Such a room, or its design/specs will likely need to become part of the 'equipment' lodged FDA which completely undermines the versatility of the app. It is simply not an option to open that can of worms.
Much better for the app to have the ability self assess the recording rnvironment prior to taking s recording ( Db measurement at the critical frequencies). As previously stated by many: the app should be idiot proof in order to reject recordings compromised by external noise factors. The nurses will quickly work out what they need to do or where they need to take the patient to get the app to accept a recording.
I do also wonder if dramatic modifications to the app will require new FdA pre/submissions. One wouldn't think so, but beaurocratic processes never favour tight time schedules.
Cheers
CT
