# FDA opens discussion on regulating generative AI devices — QANATONE

> The FDA published a discussion paper on August 18 and is taking comments until October 19. The paper sets no binding rules and sketches a…

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# FDA opens discussion on regulating generative AI devices

18 Aug 2026 1 min read News · Policy

The FDA published a discussion paper on August 18 and is taking comments until October 19. The paper sets no binding rules and sketches a two-axis risk framework.

## What the paper says

FDA's Digital Health Center of Excellence released "Considerations for the Regulation of Generative AI-Enabled Medical Devices" on August 18. It covers risk assessment, premarket evaluation and postmarket monitoring, and outlines a two-axis risk framework based on how directive a device's output is and how serious the consequences of an error are.

## Process

Comments are open under docket FDA-2026-N-7874 until October 19, 2026. The paper is a request for comment and sets no binding rules; it builds on FDA's 2024 and 2025 AI guidance.

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