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# FDA Artificial Intelligence Action Plan Outlined
- URL: https://www.fdaweb.com/fda-artificial-intelligence-action-plan-outlined/
- Published: 2021-01-13T12:00:00.000Z
- Updated: 2026-09-14T16:42:26.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5148439

Two SheppardMullin attorneys say the quick takeaway from the 1/12 publication of an FDA action plan for artificial intelligence and machine learning (AI/ML) software is that the agency will publish a guidance on change control plans, a key concept from its 4/2020 discussion paper on AI/ML software devices. In an online *FDA Law Update Blog* post, the attorneys write that while the action plan proposes a roadmap for advancing a regulatory framework, an operational framework appears to be further down the road.

The post lists the action plan section highlights as: 

- FDA will hold a public workshop on algorithm transparency;
- evaluating algorithm bias;
- FDA will publish a draft guidance on change control plans this year;
- pilot program for real-world performance monitoring; and
- building consensus for good machine learning practice.

“To developers of AI/ML, the action plan may appear modest in its objectives for 2021,” the attorneys conclude. “For example, the only specific commitment for 2021 is to publish a draft guidance on predetermined change control plans, which is only one aspect of the agency’s multi-pronged approach laid out in its discussion paper. Developers, however, can view this as a continued opportunity to engage FDA and influence the agency’s thinking on key concepts that will eventually be incorporated into a comprehensive framework.”