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US Food and Drug Administration Approval of Whole Slide Imaging for Primary Diagnosis: A Key Milestone Is Reached and
Andrew J Evans, Thomas W Bauer, Marilyn M Bui
1From the Laboratory Medicine Program, Department of Pathology, University Health Network, Toronto, Ontario, Canada (Dr Evans); the Department of Pathology and Laboratory Medicine, Hospital for Special Surgery, New York, New York (Dr Bauer); the Department of Anatomic Pathology, H. Lee Moffitt Cancer Center, Tampa, Florida (Dr Bui); the Department of Pathology, University of Colorado Denver, Aurora (Dr Cornish); Economic and Regulatory Affairs, College of American Pathologists, Washington, DC (Ms Duncan); Affiliated Pathologists Medical Group, Rancho Dominguez, California (Dr Glassy); the Medical Brain Team, Google, San Francisco, California (Dr Hipp); Covance, Indianapolis, Indiana (Dr McGee); the Surveys Department, College of American Pathologists, Northfield, Illinois (Mr Murphy); the Department of Pathology, Emory University Hospital, Atlanta, Georgia (Dr Myers); the Department of Pathology, Manchester Memorial Hospital, Manchester, Connecticut (Dr O'Neill); the Department of Pathology, Ohio State University Wexner Medical Center, Columbus (Dr Parwani); the Department of Pathology, Dell Medical School, University of Texas at Austin (Dr Rampy); ARUP Laboratories Incorporated, Salt Lake City, Utah (Dr Salama); and the Department of Pathology, University of Pittsburgh Medical Center, Pittsburgh, Pennsylvania (Dr Pantanowitz).
Abstract:
April 12, 2017 marked a significant day in the evolution of digital pathology in the United States, when the US Food and Drug Administration announced its approval of the Philips IntelliSite Pathology Solution for primary diagnosis in surgical pathology. Although this event is expected to facilitate more widespread adoption of whole slide imaging for clinical applications in the United States, it also raises a number of questions as to the means by which pathologists might choose to incorporate this technology into their clinical practice. This article from the College of American Pathologists Digital Pathology Committee reviews frequently asked questions on this topic and provides answers based on currently available information.
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