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# Draft Guide on AI Device Software Changes
- URL: https://www.fdaweb.com/draft-guide-on-ai-device-software-changes/
- Published: 2023-04-03T12:00:00.000Z
- Updated: 2026-09-14T18:23:17.000Z
- Author: David McFarland
- Tags: FDA Policy/General, #legacy-id-D5154124

*Federal Register* notice: FDA is making available a draft guidance entitled “Marketing Submission Recommendations for a Predetermined Change Control Plan for Artificial Intelligence/Machine Learning (AI/ML)-Enabled Device Software Functions.” The document describes a least burdensome approach that would support iterative improvement through modifications to machine learning-enabled device software functions. It also provides recommendations on the information to be included in a predetermined change control plan in a related marketing submission. Such a plan would describe software modifications and the associated methodology to implement these. To view the notice, click [here](https://www.govinfo.gov/content/pkg/FR-2023-04-03/pdf/2023-06786.pdf?ref=fdaweb.com).