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Current State of the Regulatory Trajectory for Whole Slide Imaging Devices in the USA

The regulatory field for digital pathology (DP) has advanced significantly. A major milestone was accomplished when the FDA allowed the first vendor to market their device for primary diagnostic use in the USA and published in the classification order that this device, and substantially equivalent d...

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Detalles Bibliográficos
Autores principales: Abels, Esther, Pantanowitz, Liron
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Medknow Publications & Media Pvt Ltd 2017
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5450449/
https://www.ncbi.nlm.nih.gov/pubmed/28584684
http://dx.doi.org/10.4103/jpi.jpi_11_17