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Conflicting information from the Food and Drug Administration: Missed opportunity to lead standards for safe and effective medical artificial intelligence solutions
The Food & Drug Administration (FDA) is considering the permanent exemption of premarket notification requirements for several Class I and II medical device products, including several artificial Intelligence (AI)–driven devices. The exemption is based on the need to rapidly more quickly dissemi...
Autores principales: | Hernandez-Boussard, Tina, Lundgren, Matthew P, Shah, Nigam |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
Oxford University Press
2021
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Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8661389/ https://www.ncbi.nlm.nih.gov/pubmed/33674865 http://dx.doi.org/10.1093/jamia/ocab035 |
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