Journal of Pathology Informatics Journal of Pathology Informatics
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Year : 2017  |  Volume : 8  |  Issue : 1  |  Page : 23

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

1 Philips, Digital Pathology Solutions, The Netherlands
2 Department of Pathology, University of Pittsburgh Medical Center, Pittsburgh, USA

Correspondence Address:
Esther Abels
Philips Electronics Nederland BV, Digital Pathology Solutions, Veenpluis 4-6, QY 2.039.1, 5684 PC Best
The Netherlands
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Source of Support: None, Conflict of Interest: None

DOI: 10.4103/jpi.jpi_11_17

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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 of medical 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.

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