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Global Life Sciences Update

New U.S. FDA Draft Guidance Outlines Path To Faster Modification of AI/ML-Enabled Devices

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The U.S. Food and Drug Administration (FDA or Agency) has issued new draft guidance on “Marketing Submission Recommendations for a Predetermined Change Control Plan for Artificial Intelligence/Machine Learning (AI/ML)-Enabled Device Software Functions”1 that discusses a “science-based approach to ensuring that AI/ML-enabled devices can be safely, effectively, and rapidly modified, updated, and improved in response to new data.”2 This approach should offer more certainty to industry as FDA’s stated goal is to allow AI/ML-enabled devices to be modified faster in accordance with FDA requirements while being “built to adapt to the data and needs of individual health care facilities” and “adapt to deliver treatments according to individual users' particular characteristics and needs.”3 Those wishing to comment on the draft guidance should note that the comment period closes on July 3, 2023.
 
The draft guidance proposes recommended information to be included in a Predetermined Change Control Plan (PCCP) as part of a marketing submission for a device that is or includes an ML-enabled device software function (ML-DSF). The PCCP would need to be reviewed and agreed to by FDA “to ensure the continued safety and effectiveness of the device,” but importantly, once it is approved or cleared as part of the marketing application, companies would not need to submit “additional marketing submissions” for each change made consistent with the plan.4

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