Digital Pathology: A Regulatory Overview

Digital pathology is a new technology and industry. Official agencies, including the Clinical Laboratory Improvement Amendments (CLIA), the College of American Pathologists (CAP), and the U.S. Food and Drug Administration (FDA), provide little guidance, and manufacturers still have to learn what it means to provide instruments to a clinical laboratory. With digital pathology now entering clinical laboratories, it is crucial for physicians and laboratory professionals to understand the regulatory requirements and how to best implement them in their clinical laboratories. The goal of this article is to provide those professionals with a comprehensive regulatory overview and a reference framework for their future work in digital pathology. This article presents the different regulatory requirements separately—first for clinical laboratories and then for medical device manufacturers.