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BBT Demo Concept • Interactive Article
BBT: Can You Survive an FDA Pre-Sub Meeting?
You have an AI-enabled SaMD product, one hour with FDA, and a validation plan held together by optimism. Choose wisely.
Question 1 of 8
Score: 0
The meeting opens politely. Too politely.
FDA asks: what exactly does your AI output do in the clinical workflow?
Notes and Sources
This quiz is intentionally lightweight and satirical in tone, but rooted in common FDA pre-submission themes for software medical devices.