Alert Failures, AI Errors, And Hypoglycemic Episodes: FDA Wants Input…

The FDA is seeking public input on how to regulate exempt health software, with specific concerns about alert failures, AI errors, and patient safety incidents like hypoglycemic episodes. The agency is attempting to define which software poses genuine risk and therefore should require oversight versus which remains safely exempt. If you build health software that doesn't touch diagnosis or treatment, you've been exempt from FDA oversight—but that door is closing. The agency is now writing rules around AI and alerts, which means your unregulated product will soon need either a compliance pathway or a business model pivot.