FDA Guidance for the Industry
Technical Performance Assessment of Digital Pathology Whole Slide Imaging Devices
Document issued on: April 20, 2016
The draft of this document was issued on February 25, 2015
FDA is issuing this guidance to provide industry and agency staff with recommendations regarding the technical performance assessment data that should be provided for regulatory evaluation of a digital whole slide imaging (WSI) system. This document does not cover the clinical submission data that may be necessary to support approval or clearance. This document provides our 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.
Recent technological advances in digital microscopy, in particular the development of whole slide scanning systems, have accelerated the adoption of digital imaging in pathology, similar to the digital transformation that radiology departments have experienced over the last decade. FDA regulates WSI system manufacturers to help ensure that the images intended for clinical uses are reasonably safe and effective for such purposes. Essential to the regulation of these systems is the understanding of the technical performance of the WSI system and the components in the imaging chain, from image acquisition to image display and their effect on pathologist’s diagnostic performance and workflow.
Prior to performing non-technical analytical studies (i.e., those using clinical samples) and clinical studies to evaluate a digital imaging system’s performance, the manufacturer should first determine the technical characteristics that are relevant to such performance for its intended use and determine any possible limitations that might affect its safety and effectiveness.
This guidance provides recommendations for the assessment of technical characteristics of a WSI device.
Download FDA Guidance in PDF
Last Updated: 2016-04-18