The Food and Drug Administration (FDA) has approved the first whole slide imaging (WSI) system for primary diagnosis. What specific regulatory steps were included in the approval process? Why did it take years to complete? What exactly has been approved and what is the impact of this decision on the field of digital pathology for clinical use? Is it still necessary for individual institutions to conduct validation studies before implementation? What are the implications for laboratories that have systems other than the one-approved system?
This CAP webinar was originally presented on December 13, 2017 in a moderated, frequently asked question and answer format. It addresses common questions pathologists have about this approval and its implications for the field of digital pathology.
Andrew J. Evans, MD, PhD, FCAP
Marilyn M. Bui, MD, PhD, FCAP
Liron Pantanowitz, MD, FCAP