Whole slide imaging systems are the subject of newly proposed guidance from the FDA addressing “technical performance assessment data that should be provided for regulatory evaluation of digital whole slide imaging (WSI) systems.” WSI involves “digitization of the stained entire tissue specimen on a glass slide” which allows a pathologist to see the slide image…
FDA Issues Guidance Affecting Digital Pathology Whole Slide Imaging
by Glenn S. Demby | Mar 24, 2015 | FDA-nir, Focus On-nir, National Lab Reporter | 0 comments