# FDA Seeks Public Feedback on Regulatory Framework for Generative AI-Enabled Medical Devices

> fda · REPORTED · 2026-08-18

On August 18, 2026, the FDA issued a discussion paper and opened public docket FDA-2026-N-7874 seeking feedback to inform its regulatory approach for generative AI-enabled medical devices, with comments due October 19, 2026. This action signals a major step in how AI-powered diagnostics and treatment-support tools will be regulated.

About FDA (CDRH): The FDA's Center for Devices and Radiological Health (CDRH) regulates medical devices including AI-enabled diagnostic and therapeutic technologies used across all medical specialties.

- Company: FDA (CDRH)
- Sector: medical devices
- Primary source: https://novapharmanews.com/us/news/fda-generative-ai-medical-devices-discussion-paper-august-2026

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Source: MedFuel Intel news monitor. Verification tier: REPORTED. Informational only, not investment advice. Corrections: media@medfuelinc.com.