A Move by the FDA Signals Possible Classification for Patient Safety and Industry Collaboration
On Jan. 14, 2016, the Digital Pathology Association (DPA) issued a press release suggesting “digital pathology manufacturers currently interested in marketing whole slide imaging (WSI) devices for primary diagnosis in the United States submit de novo applications to the Food and Drug Administration (FDA).”
What exactly does this mean?
The press release goes on to say, “The FDA had previously stated it considered WSI for primary diagnosis to be a Class III medical device. However, FDA had never formally