Intended Use Draws the Line

Device status often hides inside the claim. Intended use Ask what the product is supposed to do in the world. A general wellness cue is different from a diagnostic, treatment, prevention, or mitigation claim. Indications for use Add the condition, patient population, and clinical setting. This turns a broad purpose into a specific regulatory statement. Evidence trail Look beyond the homepage. Sales decks, app prompts, onboarding screens, IFUs, labels, demos, and customer support scripts can all signal intended use.

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