Digital Pathology Association Weighs-In on First FDA Draft Guidance for Whole Slide Imaging

On Feb 25, 2015, The Food and Drug Administration (FDA) announced the availability of a draft guidance entitled “Technical Performance Assessment of Digital Pathology Whole Slide Imaging Devices”. This draft guidance provides industry and Agency staff with recommendations regarding the technical performance assessment data that should be submitted for regulatory evaluation of a digital whole slide imaging (WSI) system. This draft guidance is not final nor is it in effect at this time.


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Published in: Press Releases  on Friday 20th of March 2015