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Fda Issues Draft Guidance For Artificial Intelligence Machine Learning Ai Ml Enabled Device Software Functions News Today : Breaking News, Live Updates & Top Stories | Vimarsana

FDA Issues Draft Guidance For Artificial Intelligence/Machine Learning (AI/ML)-Enabled Device Software Functions - Food and Drugs Law

A PCCP must be reviewed by FDA and established as part of a marketing authorization prior to a manufacturer's implementing any modifications under the PCCP.

Drug administrationSoftware functionsSubmission recommendationsPredetermined change control planMachine learningEnabled deviceDrug omnibus reform actPredetermined change control plansModification protocolImpact assessmentAppropriations actFda issues draft guidance for artificial intelligence machine learning ai ml enabled device software functionsLife sciencesFood and drugs lawNew technology

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