Hi All,
This guidance is applicable to AI-DSFs ( AI-enabled device software functions) that the manufacturer intends to modify over time. This includes AI-DSFs for which modifications to the AI model are implemented automatically (i.e., for which the modifications are implemented automatically by software, also known as "continuous learning"), AI-DSFs for which modifications to the AI model are implemented manually (i.e., involving steps that require human input, action, review, and/or decision-making, and therefore are not implemented automatically), or a combination of both.
This guidance describes an approach that would often be least burdensome for manufacturers to support the ability to modify an AI-DSF while maintaining the safety and effectiveness of the device across the intended use populations. Specifically, this guidance includes recommendations on the information that should be included in the PCCP (Predetermined Change Control Plan) in a marketing submission for an AI-DSF.
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Michael Roza CPA, CISA, CIA, CC, CCSKv5, CCZTv1, MBA, EMBA, CSA
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