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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)....

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Detalles Bibliográficos
Autores principales: Smith, James Andrew, Abhari, Roxanna E, Hussain, Zain, Heneghan, Carl, Collins, Gary S, Carr, Andrew J
Formato: Online Artículo Texto
Lenguaje:English
Publicado: BMJ Publishing Group 2020
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