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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
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)....
Autores principales: | Smith, James Andrew, Abhari, Roxanna E, Hussain, Zain, Heneghan, Carl, Collins, Gary S, Carr, Andrew J |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
BMJ Publishing Group
2020
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Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7559037/ https://www.ncbi.nlm.nih.gov/pubmed/33055121 http://dx.doi.org/10.1136/bmjopen-2020-039969 |
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