When the Algorithm Is a Device: AI, the FDA, and the Question Almost Nobody Is Asking
The AI tool you bought last quarter, the one bundled into your EHR upgrade, the one your hospital piloted on your unit. Was it cleared by the FDA as a medical device? Most physicians do not know the answer. The vendor's pitch deck almost certainly did not lead with it. And the answer matters, because once an algorithm crosses into FDA medical device territory, the rules that govern what it can claim, how it has to perform, who is liable when it fails, and what evidence the manufacturer had to produce before it reached your practice change categorically. In this episode of The Clinical…
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