The Food and Drug Administration (FDA) is announcing the availability of a draft guidance entitled ``Technical Performance Assessment of Digital Pathology Whole Slide Imaging Devices.'' This draft guidance provides industry and Agency staff with recommendations regarding the technical performance assessment data that should be provided for regulatory evaluation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 This draft guidance is not final nor is it in effect at this time.
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Technical Performance Assessment of Digital Pathology Whole Slide Imaging Devices; Draft Guidance for Industry and Food and Drug Administration Staff; Availability
The Food and Drug Administration (FDA) is announcing the availability of a draft guidance entitled ``Technical Performance Assessment of Digital Pathology Whole Slide Imaging De...
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80 FR 10122
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“Technical Performance Assessment of Digital Pathology Whole Slide Imaging Devices; Draft Guidance for Industry and Food and Drug Administration Staff; Availability,” thefederalregister.org (February 25, 2015), https://thefederalregister.org/documents/2015-03843/technical-performance-assessment-of-digital-pathology-whole-slide-imaging-devices-draft-guidance-for-industry-and-food-a.