Will the FDA recall any 510k cleared medical device for adverse events caused by defective AI software by the end of 2023?
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This market resolves YES if by the end of 2023 the FDA recalls a previously cleared medical device for adverse events related to AI software. Resolves NO if not.
Sep 10, 9:56pm:
Sep 10, 9:56pm: Will the FDA recall any 510k cleared medical device for adverse events caused by defective AI software by the end of 2023? → Will the FDA recall any 510k cleared medical device for adverse events caused by defective AI software by the end of 2023?
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@M YES!! HA! Sorry about that. It actually meant AI devices with regulatory "clearance". Only drugs get approved, devices are cleared - HUGE difference in terms of the evidence required and level of scrutiny.
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