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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Bibliographic Details
Published inJournal of pathology informatics Vol. 8; no. 1; p. 23
Main Authors Abels, Esther, Pantanowitz, Liron
Format Journal Article
LanguageEnglish
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
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Summary: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 devices of this generic type, should be classified into class II instead of class III as previously proposed. The Digital Pathology Association (DPA) regulatory task force had a major role in the accomplishment of getting the application request for Whole Slide Imaging (WSI) Systems recommended for a de novo. This article reviews the past and emerging regulatory environment of WSI for clinical use in the USA. A WSI system with integrated subsystems is defined in the context ofmedical device regulations. The FDA technical performance assessment guideline is also discussed as well as parameters involved in analytical testing and clinical studies to demonstrate that WSI devices are safe and effective for clinical use.
Bibliography:ObjectType-Article-2
SourceType-Scholarly Journals-1
ObjectType-Feature-3
content type line 23
ObjectType-Review-1
ISSN:2153-3539
2229-5089
2153-3539
DOI:10.4103/jpi.jpi_11_17