Industry ties and evidence in public comments on the FDA framework for modifications to artificial intelligence/machine learning-based medical devices: a cross sectional study.
PMID: 33055121 ·
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Zusammenfassung
To determine the extent and disclosure of financial ties to industry and use of scientific evidence in comments on a US Food and Drug Administration (FDA) regulatory framework for modifications to artificial intelligence/machine learning (AI/ML)-based software as a medical device (SaMD). Cross-sectional study. We searched all publicly available comments on the FDA 'Proposed Regulatory Framework for Modifications to Artificial Intelligence/Machine Learning (AI/ML)-Based Software as a Medical Devi
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