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

• Published in: Journal of pathology informatics Vol. 8; no. 1; p. 23
• Main Authors: Abels, Esther, Pantanowitz, Liron
• Format: Journal Article
• Language: English
• Published: India Elsevier Inc 01.01.2017; Wolters Kluwer India Pvt. Ltd; Medknow Publications & Media Pvt. Ltd; Medknow Publications & Media Pvt Ltd; Elsevier
• Subjects: Classification; De novo; Devices; Diagnostic systems; digital; Digital imaging; digital pathology; Digital Pathology Association; FDA approval; Feasibility studies; Federal regulation; Food and Drug Administration; Laboratories; Manufacturers; Medical device industry; Medical devices; Medical equipment; Medical technology; Pathology; Performance assessment; premarket approval; regulation; Review; User training; whole slide imaging; United States > US; digital; regulation; digital pathology; Digital Pathology Association; whole slide imaging; premarket approval; De novo; Food and Drug Administration

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...