Technical Performance Assessment of Digital Pathology Whole Slide Imaging Devices; Guidance for Industry and Food and Drug Administration Staff; Availability

The Food and Drug Administration (FDA or Agency) is announcing the availability of a guidance entitled ``Technical Performance Assessment of Digital Pathology Whole Slide Imaging Devices.'' This guidance provides industry and Agency staff with recommendations regarding the technical performance assessment data for the evaluation of a digital whole slide imaging (WSI) system. The guidance provides suggestions on how to best characterize the technical aspects that are relevant to WSI performance for their intended use and determine any possible limitations that might affect their safety and effectiveness.