Guidance seen as sign of FDA openness to digital pathology

The Food and Drug Administration has issued final guidance for industry and agency staff on how to assess the technical performance of whole-slide imaging devices. During a Digital Pathology Association webinar on the FDA action, experts said the guidance is another strong sign of the agency’s working to detail the standards manufacturers will need to meet to earn approval for WSI’s use in primary diagnosis.

The lead item in  CAP TODAY’s “Put It on the Board” section.  The whole shebang.