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Regulatory Challenges and Opportunities for Digital Pathology

By Nick Anderson

FDA/CDRH/OIR, Division of Molecular Genetics and Pathology

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FDA has cleared or approved a number of digital pathology devices for different intended uses, such as digital read and image analysis of immunohistochemically stained tissue slides, classification and enumeration of peripheral blood cells, and initial screening of cervical cytology slides.  FDA has been actively engaged in discussions with various stakeholders regarding whole slide imaging systems intended for primary diagnosis of H&E stained slides. To ensure that the images produced from H&E stained slides are safe and effective for use as an aid in primary diagnosis of cancer, FDA has maintained that WSI manufacturers should assess technical performance of the components in the imaging chain, and demonstrate analytical and clinical performance using a sufficient number of specimens and readers representative of the intended use populations.  FDA has provided WSI manufacturers with outlines of various validation studies and performance measures. This presentation is intended to provide an overview of regulatory challenges and opportunities for WSI.


Dr. Anderson is a scientific reviewer in FDA’s Office of In Vitro Diagnostics and Radiological Health. He earned his B.S. in Mathematics and his M.S. and Ph.D. in Industrial Engineering with focus on simulation, optimization, and algorithm development. He has over 20 years engineering experience in areas ranging from heavy manufacturing to logistics to missile defense. He joined the Office of In Vitro Diagnostics and Radiological Health in 2010 where he provides scientific review of pre-submissions, 510(k)s and PMAs submitted to the Division of Molecular Genetics and Pathology. He specializes in the review of hardware and software, assessing safety and effectiveness. 

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Researchers should cite this work as follows:

  • Nick Anderson (2016), "Regulatory Challenges and Opportunities for Digital Pathology,"

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Brandon D. Gallas

FDA/CDRH/OSEL, Division of Imaging, Diagnostics, and Software Reliability