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# AI/ML Medical Device Action Plan
- URL: https://www.fdaweb.com/ai-ml-medical-device-action-plan/
- Published: 2021-01-12T12:00:00.000Z
- Updated: 2026-09-14T16:42:22.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5148421

The CDRH Digital Health Center of Excellence has issued its “Artificial Intelligence/Machine Learning (AI/ML)-Based Software as a Medical Device Action Plan.” An agency [statement](https://content.govdelivery.com/accounts/USFDA/bulletins/2b56bd7?ref=fdaweb.com) (contains a link to the action plan) says the plan is a direct response to stakeholder feedback to a 4/2019 discussion paper on a proposed regulatory framework for modifications to AI/ML software as a medical device. The plan outlines five actions FDA will take: 

- further develop the proposed regulatory framework by issuing a draft guidance on a predetermined change control plan;
- support the development of good machine learning practices to evaluate and improve machine learning algorithms;
- foster a patient-centered approach, including device transparency to users;
- develop methods to evaluate and improve machine learning algorithms; and
- advance real-world performance monitoring pilots.