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Review
. 2017 May 15:8:23.
doi: 10.4103/jpi.jpi_11_17. eCollection 2017.

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

Esther Abels  1 , Liron Pantanowitz  2
Affiliations
Review

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

Esther Abels et al. J Pathol Inform. .

Abstract

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.

Keywords: De novo; Digital Pathology Association; Food and Drug Administration; digital; digital pathology; premarket approval; regulation; whole slide imaging.

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Conflict of interest statement

There are no conflicts of interest.

Figures

Figure 1
Figure 1
Overview of a digital pathology system. A digital pathology system is composed of two subsystems: (A) Image acquisition and (B) workstation environment. The arrows depict the pixel data pathway[15]
Figure 2
Figure 2
Algorithm for evaluating substantial equivalence in 510(k) premarket notifications
See this image and copyright information in PMC

References

    1. Pantanowitz L, Parwani AV. Digital Pathology. Chicago, USA: ASCP Press; 2017.
    1. Titus K. Regulators scanning the digital scanners. CAP Today. 2012;26:56–62.
    1. Parwani AV, Hassell L, Glassy E, Pantanowitz L. Regulatory barriers surrounding the use of whole slide imaging in the United States of America. J Pathol Inform. 2014;5:38. - PMC - PubMed
    1. [Last accessed 2017 Feb 01];DPA Recommends whole Slide Imaging Manufacturers Submit De novo Applications to the FDA for Primary Diagnosis in the United States. Available from: http://www.prweb.com/releases/2016/01/prweb13163307.htm .
    1. [Last accessed on 2017 Feb 01];FDA Overview of Device Regulation. Available from: http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/Overview/d... .