Lexology December 9, 2024
Last week, the U.S. Food and Drug Administration (FDA) finalized guidance on the types of information that should be included in a Predetermined Change Control Plan (PCCP) as part of a marketing submission for an artificial intelligence-enabled device software function (AI-DSF). The guidance describes the process by which AI device sponsors may seek approval for modifications in advance by submitting a PCCP document as part of a premarket submission, which should describe the anticipated changes and how they will be tested, implemented, and monitored. Below we analyze how the final version of the guidance differs from its April 2023 draft form, and also summarize takeaways from FDA’s new report on the health risks and benefits of non-device software functions.
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