Fda Publishes Draft Guidance For Predetermined Change Control Plan Ai Ml Enabled Device Software Functions News Today : Breaking News, Live Updates & Top Stories | Vimarsana

On April 3, 2023, FDA released the draft guidance titled "Marketing Submission Recommendations for a Predetermined Change Control Plan for Artificial Intelligence/Machine Learning (AI/ML)-Enabled Device Software Functions".

White houseDistrict of columbiaUnited statesSoftware functionsSubmission recommendationsPredetermined change control planMachine learningEnabled deviceRegulatory frameworkBased softwareAction planConsolidated appropriations actDrug omnibus reform actCosmetic actModification protocolManagement practices