ENZYME BLOGAnalyzing the latest developments in regulatory, compliance, and quality

Artificial Intelligence SaMDApril 12, 2023

FDA (Finally) Publishes Change Control Draft Guidance for Artificial Intelligence

Several features of this draft suggest companies will have to do a significant amount of work in the premarket phase for development of a predetermined change control protocol (PCCP), making the development process potentially lengthier and more expensive.

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Enhao Gong, CEOSubtle Medical

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Judy Brimacombe, VP Clinical, QA, RADawnLight Technologies

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Ivan Ma, Director of OperationsPerceptive Navigation

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ENZYME BLOGAnalyzing the latest developments in regulatory, compliance, and quality

FDA (Finally) Publishes Change Control Draft Guidance for Artificial Intelligence

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