Very nice read by Dr. Holger Lange of Flagship Biosciences in this month's ASCP LabMedicine (subscription required) on regulatory issues in digital pathology. Holger provides a clear overview of the issues pertinent to digital pathology today.
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.
Read full text or download PDF as LabMedicine (subscription required).