FDA convenes digital pathology advisory panel Oct 22-23

The FDA are convening a public advisory committee tomorrow and Friday Oct 22-23 to discuss discuss and make recommendations about "public health issues" related to the use of digital whole slide imaging (WSI) systems.  They have posted a briefing document.

The FDA is sponsoring this 2‐day Advisory Panel meeting on Digital Pathology Whole Slide Imaging (WSI) to gather expert information for how to ensure that the current standards of safety and effectiveness of routine surgical pathlogy will not be compromised if digital WSI is used as a substitute for the conventional light microscope.  For over 100 years, the reference method for the diagnosis of cancer and many other critical clinical conditions has been by histopathology using he conventional light microscopy.  This process and medical practice is known as surgical pathology in the United States.

Digital pathology is the use of computer technology to convert analog microscopic images into digital images that are similar to digital photography.  Digital WSIs do not replace the glass microscope slide.  The glass microscope has to be prepared just like with the light microscope and is the source of the information to be digitied.  However, there are many functions that digital WSIs offer that are not possible with light microscope examinations.  These include the integrating the workflow of the pathologist with the electronic medical record, retrieval of previous biopsy images using the computer, split screen comparison of 2 or more images from the same case or different cases, ability to use WSI data for computer‐assisted image analysis and manipulation, transmission of digital images to the patient’s electronic chart, the internet and other links, and so forth.

The panel will hear presentations from a variety of experts and FDA officials, and also a number of individuals who have registered to speak during the public comments portion of the agenda (such as me; I plan to present some remarks about Measuring Accuracy in Digital Pathology).

The FDA have posed a number of questions that they would like the panel to answer; the ultimate result will probably be a guidance document for companies filing for clearance or approval of their devices for various applications in digital pathology.  It should be a fascinating and informative couple of days; please stay tuned for a report!