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# Whole Slide Imaging Device Assessment Guidance
- URL: https://www.fdaweb.com/whole-slide-imaging-device-assessment-guidance/
- Published: 2016-04-19T12:00:00.000Z
- Updated: 2026-09-14T20:55:50.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5135420

> FDA has issued a guidance, *Technical Performance Assessment of Digital Pathology Whole Slide Imaging Device*, with recommendations for the technical assessment performance data to be provided for regulatory evaluation of a digital whole slide imaging system. The [document](http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/UCM435355.pdf?ref=fdaweb.com) does not cover the clinical submission data that may be necessary to support approval or clearance.  
>  
> Whole Slide Imaging systems are defined in the guidance as consisting of **(1)** an image acquisition subsystem that converts the content of a glass slide into a digital image file and **(2)** a workstation environment for viewing the digital image.