FDA finalizes AI-enabled medical device life cycle plan guidance

FDA finalizes AI-enabled medical device life cycle plan guidance

The agency said it will review developers’ modified Predetermined Change Control Plans for artificial intelligence and machine learning submissions that have already been approved without triggering the need for new marketing submissions. Analytics, AI, Regulation, Digital Health, Medical devices, Emerging Technologies, Machine learning, Data and Information, Public Policy, Technology News from healthcareitnews.com

​The agency said it will review developers’ modified Predetermined Change Control Plans for artificial intelligence and machine learning submissions that have already been approved without triggering the need for new marketing submissions. 

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