Current state of the regulatory trajectory for whole slide imaging devices in the USA

Article English OPEN
Abels, Esther; Pantanowitz, Liron;
  • Publisher: Wolters Kluwer Medknow Publications
  • Journal: Journal of Pathology Informatics,volume 8 (issn: 2153-3539, eissn: 2153-3539)
  • Publisher copyright policies & self-archiving
  • Related identifiers: pmc: PMC5450449, doi: 10.4103/jpi.jpi_11_17
  • Subject: digital | Food and Drug Administration | RB1-214 | R858-859.7 | Review Article | Computer applications to medicine. Medical informatics | Pathology | De novo | premarket approval | regulation | digital pathology | whole slide imaging | Digital Pathology Association

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, ... View more
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