2019
DOI: 10.1101/2019.12.11.19013953
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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

Abstract: Objectives 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). Design Cross-sectional study. Setting We searched all publicly available comments on the FDA "Proposed Regulatory Framework for Modifications to Artificial Intelligence/Machine Learning (AI/ML)-Based Software as … Show more

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References 18 publications
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