FDA Finalizes Guidance for AI-Enabled Medical Devices
Summary
On December 4, 2024, the Food and Drug Administration (FDA) issued final guidance to provide recommendations for predetermined change control plans (PCCPs) tailored to AI-enabled device software functions, applicable to De Novo, premarket approval (PMA), and premarket notification (510(k)) pathways. FDA recognizes that development of AI-enabled devices is an iterative process, and PCCPs are intended to allow developers to plan for modifications, while continuing to provide a reasonable assurance of safety and effectiveness. FDA’s guidance provides that a PCCP should include planned modifications; a methodology to develop, validate, and implement those modifications; and an assessment of an impact of those modifications. This guidance builds upon concepts for AI and machine learning that FDA initially introduced in 2019.
