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GUIDANCE DOCUMENT

Technical Performance Assessment of Digital Pathology Whole Slide Imaging Devices Guidance for Industry and Food and Drug Administration Staff April 2016

Final

Technical Performance Assessment of Digital Pathology Whole Slide Imaging Devices

Docket Number:
FDA-2015-D-0230
Issued by:
Guidance Issuing Office
Center for Devices and Radiological Health

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.


Submit Comments

You can submit online or written comments on any guidance at any time (see 21 CFR 10.115(g)(5))

If unable to submit comments online, please mail written comments to:

Division of Dockets Management (HFA- 305)
Food and Drug Administration
5630 Fishers Lane, Rm. 1061
Rockville, MD 20852

All written comments should be identified with this document's docket number: FDA-2015-D-0230.