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Marketing and US Food and Drug Administration Clearance of Artificial Intelligence and Machine Learning Enabled Software in and as Medical Devices: A Systematic Review
IMPORTANCE: The marketing of health care devices enabled for use with artificial intelligence (AI) or machine learning (ML) is regulated in the US by the US Food and Drug Administration (FDA), which is responsible for approving and regulating medical devices. Currently, there are no uniform guidelin...
Autores principales: | , , |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
American Medical Association
2023
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Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10323702/ https://www.ncbi.nlm.nih.gov/pubmed/37405771 http://dx.doi.org/10.1001/jamanetworkopen.2023.21792 |