Digital Pathology: A Regulatory Overview

Lange, Holger

doi:10.1309/lma2m9nqqf0zcvhc

Cited by 25 publications

(25 citation statements)

References 3 publications

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“…[8] However, the FDA had never formally classified WSI devices. Until recently, the FDA had not yet cleared or approved WSI for routine surgical pathology diagnosis to replace conventional light microscopy, while several WSI systems had been cleared for limited use as Class II devices, for the quantification of immunohistochemical stains (e.g.…”

Section: Whole Slide Imaging Regulatory Backgroundmentioning

confidence: 99%

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

Abels

Pantanowitz

2017

Journal of Pathology Informatics

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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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Section: Whole Slide Imaging Regulatory Backgroundmentioning

confidence: 99%

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

Abels

Pantanowitz

2017

Journal of Pathology Informatics

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“…Third, stereology approaches will likely prove to be a better gold standard for which to compare new wholetissue image analysis algorithms that require FDA clearance. 14 Recent image analysis clearances in breast cancer tumor markers have required comparisons in precision and accuracy with pathologists, [15][16][17] and the need for a more precise and potentially more accurate gold standard remains.…”

Section: Discussionmentioning

confidence: 99%

Tissue Pattern Recognition Error Rates and Tumor Heterogeneity in Gastric Cancer

Potts¹,

Huff²,

Lange³

et al. 2013

Applied Immunohistochemistry &Amp; Molecular Morphology

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The anatomic pathology discipline is slowly moving toward a digital workflow, where pathologists will evaluate whole-slide images on a computer monitor rather than glass slides through a microscope. One of the driving factors in this workflow is computer-assisted scoring, which depends on appropriate selection of regions of interest. With advances in tissue pattern recognition techniques, a more precise region of the tissue can be evaluated, no longer bound by the pathologist's patience in manually outlining target tissue areas. Pathologists use entire tissues from which to determine a score in a region of interest when making manual immunohistochemistry assessments. Tissue pattern recognition theoretically offers this same advantage; however, error rates exist in any tissue pattern recognition program, and these error rates contribute to errors in the overall score. To provide a real-world example of tissue pattern recognition, 11 HER2-stained upper gastrointestinal malignancies with high heterogeneity were evaluated. HER2 scoring of gastric cancer was chosen due to its increasing importance in gastrointestinal disease. A method is introduced for quantifying the error rates of tissue pattern recognition. The trade-off between fully sampling tumor with a given tissue pattern recognition error rate versus randomly sampling a limited number of fields of view with higher target accuracy was modeled with a Monte-Carlo simulation. Under most scenarios, stereological methods of sampling-limited fields of view outperformed whole-slide tissue pattern recognition approaches for accurate immunohistochemistry analysis. The importance of educating pathologists in the use of statistical sampling is discussed, along with the emerging role of hybrid whole-tissue imaging and stereological approaches.

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“…[108] FDA clearance for image analysis algorithms enabling quantitative analysis of immunohistochemical cancer markers for estrogen receptor, progesterone receptor and others first occurred in 2003. [109] Research continues with extensions into parallel and grid-based systems capable of supporting digital slide sign out in routine surgical pathology practice, computer-aided diagnosis, content-based image retrieval, and 3D image reconstruction. [104110111112] As the use of WSI evolved, the need for imaging standards specific to pathology emerged.…”

Section: The Americasmentioning

confidence: 99%

The history of pathology informatics: A global perspective

Park

Parwani

Aller

et al. 2013

Journal of Pathology Informatics

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Pathology informatics has evolved to varying levels around the world. The history of pathology informatics in different countries is a tale with many dimensions. At first glance, it is the familiar story of individuals solving problems that arise in their clinical practice to enhance efficiency, better manage (e.g., digitize) laboratory information, as well as exploit emerging information technologies. Under the surface, however, lie powerful resource, regulatory, and societal forces that helped shape our discipline into what it is today. In this monograph, for the first time in the history of our discipline, we collectively perform a global review of the field of pathology informatics. In doing so, we illustrate how general far-reaching trends such as the advent of computers, the Internet and digital imaging have affected pathology informatics in the world at large. Major drivers in the field included the need for pathologists to comply with national standards for health information technology and telepathology applications to meet the scarcity of pathology services and trained people in certain countries. Following trials by a multitude of investigators, not all of them successful, it is apparent that innovation alone did not assure the success of many informatics tools and solutions. Common, ongoing barriers to the widespread adoption of informatics devices include poor information technology infrastructure in undeveloped areas, the cost of technology, and regulatory issues. This review offers a deeper understanding of how pathology informatics historically developed and provides insights into what the promising future might hold.

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Digital Pathology: A Regulatory Overview

Cited by 25 publications

References 3 publications

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

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

Tissue Pattern Recognition Error Rates and Tumor Heterogeneity in Gastric Cancer

The history of pathology informatics: A global perspective

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