Regulatory barriers surrounding the use of whole slide imaging in the United States of America

The last decade has seen significant technology advances in the evolution of whole slide imaging (WSI) with the ability to rapidly digitize large numbers of slides automatically and at high resolution. Many applications have emerged and, as a result, WSI is increasingly being used in both clinical and research areas.1,2,3,4 One of the major barriers that has halted the widespread use of this technology in the United States has been regulatory issues, particularly the impact of classifying WSI devices as Class III by the U.S. Food and Drug Administration (FDA).