FDA Announces Availability of Draft Guidance on WSI Devices

Submit electronic comments on the draft guidance to http://www.regulations.gov. Submit written comments to the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. Identify comments with the docket number found in brackets in the heading of this document.

FOR FURTHER INFORMATION CONTACT: Nicholas Anderson, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, rm. 5570, Silver Spring, MD 20993-0002, 301-796-4310; or Aldo Badano, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 62, rm. 3116, Silver Spring, MD 20993-0002, 301-796-2534.

Recent technological advances in digital microscopy, in particular the development of whole slide scanning systems, have accelerated the adoption of digital imaging in pathology, similar to the digital transformation that radiology departments have experienced over the last decade. FDA regulates WSI systems manufacturers to ensure that the images produced for clinical intended uses are safe and effective for such purposes. Essential to the regulation of these systems is the understanding of the technical performance of the components in the imaging chain, from image acquisition to image display and their effect on pathologist’s diagnostic performance and workflow.