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# Guide on Change Control Plans for AI Devices
- URL: https://www.fdaweb.com/guide-on-change-control-plans-for-ai-devices/
- Published: 2024-12-04T12:00:00.000Z
- Updated: 2026-09-14T14:48:32.000Z
- Author: David McFarland
- Tags: FDA Policy/General, #legacy-id-D5158300

*Federal Register* notice: FDA is making available a final guidance entitled “Marketing Submission Recommendations for a Predetermined Change Control Plan for Artificial Intelligence (AI)-Enabled Device Software Functions.” The document provides recommendations on the information to include in a Predetermined Change Control Plan in a marketing submission for a device that includes one or more AI-enabled device software functions (AI–DSFs). It recommends that such plans describe the planned software modifications, the associated methodology to develop, validate and implement those modifications, and an assessment of the impact of those modifications. To view the notice, click [here](https://www.govinfo.gov/content/pkg/FR-2024-12-04/pdf/2024-28361.pdf?ref=fdaweb.com).