FDA 510K Clearance For Digital Pathology: What is it? What’s the process?
What is the FDA 510K clearance for a Software as a Medical Device (SaMD) for Digital Pathology? How does this compare to the IVDR/CE process in Europe?
What is the FDA 510K clearance for a Software as a Medical Device (SaMD) for Digital Pathology? How does this compare to the IVDR/CE process in Europe?