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

Issue Date: April 20, 2016
Issued by: Center for Devices and Radiological Health
Topic(s): Premarket, 510(k), Labeling, Laboratory Tests, IVDs (In Vitro Diagnostic Devices)
Status: Final

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

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.

Download the Guidance Document

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