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FDA issues guidance on predetermined change control plans for AI/ML-enabled device software functions – Commentary

IntroductionIn more detailDescription of modificationModification protocolImpact assessmentAuthorised PCCPsCommentIntroductionOn 3 April 2023, the Food and Drug Administration (FDA) issued a draft guidance for industry,(1) for manufacturers whose medical devices use machine learning (ML)…

Source: www.lexology.comRead more

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