Hello,
We are updating our 510(k) with a new predictive claim on AI. As this field is so new we want to verify guidance made by our hired full-time consultants as being "In the ballpark as correct for FDA's thinking." Our goal is a pre-sub soon and we don't want to get there with FDA asking us questions or commenting on the data we didn't consider.
PM me if you feel confident doing this or are aware of "an expert" in FDA thinking around AI as it seems to be evolving. If you want to create a billable SoW prior thats fine too.
I had requested this previously but that was premature.
Thanks,
Ed
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Edward Panek
VP, QA/RA
Med Device
USN Veteran
Research into Neural Nets -
https://www.twitch.tv/edosani------------------------------