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...

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Detalles Bibliográficos
Autores principales: Hernandez-Boussard, Tina, Lundgren, Matthew P, Shah, Nigam
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Oxford University Press 2021
Materias:
Perspective
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

Internet

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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