FDA sheds light on digital pathology standards

Draft guidance issued by the Food and Drug Administration in February lays out the agency’s expectations for the technical specifications of whole-slide imaging devices used in digital pathology.

While the FDA document does not cover the more controversial area of what clinical data companies would need to submit to gain marketing approval for whole-slide imaging devices in primary diagnosis, Liron Pantanowitz, MD, says the agency’s move is significant. He is a member of the CAP’s Digital Pathology Committee and associate professor of pathology and biomedical informatics at the University of Pittsburgh Medical Center.

Also from the “Put It on the Board” section this month. Read the whole shebang.