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The Food and Drug Administration (FDA) has announced the availability of draft guidance for devices that use artificial intelligence (AI)-enabled software functions. This draft guidance, once finalized, will give recommendations for what should be included in marketing submissions, focusing on safety and effectiveness. It suggests a total product lifecycle (TPLC) approach, which considers the design, development, and implementation stages of AI-enabled devices. Public comments on this draft are sought to ensure that FDA’s guidance aligns with the fast-evolving field of AI and adequately addresses performance and risk concerns.

The Food and Drug Administration (FDA) has released a final guidance document on marketing submissions for devices with artificial intelligence-enabled software. This guidance provides recommendations for including a Predetermined Change Control Plan (PCCP) in submissions, which outlines planned AI software modifications, their development and validation, and their potential impact. The FDA aims to streamline the approval process for such modifications by avoiding repeated marketing submissions while ensuring device safety and effectiveness. The guidance reflects the FDA's efforts to regulate AI-enabled medical device software innovatively and effectively.