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# AI/ML Predetermined Change Control Plan Guidance
- URL: https://www.fdaweb.com/ai-ml-predetermined-change-control-plan-guidance/
- Published: 2023-05-09T12:00:00.000Z
- Updated: 2026-09-14T18:30:22.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5154404

Three Hyman, Phelps & McNamara staffers, a medical device regulation expert and two attorneys, say a recent FDA draft guidance on predetermined change control plans (PCCP) for artificial intelligence/machine learning (AI/ML)-enabled device software functions (ML-DSF) is intended to reduce the need for prior FDA authorization of modifications to the software functions. [Writing](https://www.thefdalawblog.com/2023/05/change-is-inevitable-plan-ahead-an-assessment-of-fdas-draft-guidance-on-predetermined-change-control-plans-for-artificial-intelligence-machine-learning-enabled-device-software-func/?utm%5Fsource=rss&utm%5Fmedium=rss&utm%5Fcampaign=change-is-inevitable-plan-ahead-an-assessment-of-fdas-draft-guidance-on-predetermined-change-control-plans-for-artificial-intelligence-machine-learning-enabled-device-software-func) in their firm’s *FDA Law Blog*, the three give the history of the development of PCCPs and an overview of the draft guidance.

“PCCPs provide a new mechanism for introducing certain significant changes to an ML-DSF,” the three write. “The use of a PCCP is not required; a manufacturer can continue to implement significant device changes via supplemental submissions to FDA. However, including a PCCP can speed up the process of making post-market software modifications and potentially reduce costs by avoiding additional marketing submissions.”

The online post concludes that FDA recommends that manufacturers discuss the PCCP strategy with it through the Q-Submission program before submitting a marketing submission with a PCCP.