The Digital Pathology Association (DPA), a non-profit organization that facilitates education and awareness of digital pathology applications, will include a Regulatory Panel at their upcoming annual conference, Pathology Visions. Pathology Visions will be held October 20 – 21, 2014 in San Francisco at the Hyatt Regency.
The Regulatory Panel, scheduled to take place near the end of the second day of Pathology Visions, will include two panelists, Jeffrey N. Gibbs and Dr. Kathleen M. Sayles. Mr. Gibbs’ presentation, titled “FDA Regulation of Digital Pathology: LDTs and Other Developments,” will cover FDA regulation of digital pathology; FDA regulation of laboratory’s developed tests (LDTs); the implications of FDAs regulation of LDTs for digital pathology; and next steps for the LDT draft guidance.
Dr. Gibbs has represented health care companies on FDA-related matters since 1984. He advises companies on a wide variety of issues, including product approvals, marketing, clinical studies, and enforcement. His practice focuses on devices, particularly the regulation of diagnostic products. Previously, he served in the Chief Counsel’s Office of the U.S. Food and Drug Administration, where he became an Associate Chief Counsel for Enforcement. While at FDA, Mr. Gibbs received the FDA Award of Merit. He also was appointed a Special Assistant United States Attorney for the District of Columbia. Before joining FDA, he clerked for a United States District Court Judge in the District of New Jersey. Mr. Gibbs has written and lectured extensively on a variety of FDA-related topics. Mr. Gibbs served as a member of the Editorial Advisory Board for the Food and Drug Law Journal from 1998 to 2004, and was Chair in 2003-2004. Mr. Gibbs served as a member of the Human Subjects Research Board for George Mason University from 2003-2011. Mr. Gibbs serves as Secretary and General Counsel of the Board of Directors of the Food and Drug Law Institute. He is a graduate of Princeton University (1975 summa cum laude) and the New York University School of Law (1978 with honors). He is admitted to practice law in the District of Columbia. To learn more about Jeffrey Gibbs and his presentation, please click here.
Dr. Sayles will provide a presentation titled, “Implementation of WSI: Regulatory Considerations”. The experience of the Pathology Laboratory at SUNY Upstate with respect to decisions regarding the use of LDT’s vs. FDA approved tests will be discussed. Our lab is CLIA exempt and validates all testing through the NYSDOH (New York State Department of Health). Historically, if an FDA approved kit or test becomes available, we will consider its use but do not always make the decision to do so as long as the LDT in current use has been validated and approved through the NYSDOH. We view Digital Pathology much in the same way as we view traditional LDT’s and IVD’s. The FDA has classified WSI as a Class III Medical Device but has not yet issued guidance for use. Although the FDA has not approved it for IVD use beyond Her2 reading on a monitor, we intend to validate WSI for internal use following our procedure used for other tests/platforms requiring validation. We will validate using the guidelines set forth by the CAP, consult CLIA regulation CFR 493.1253 for guidance regarding off label use of devices (similar to the situation when the FDA published guidance for off label use of Glucose meters for critically ill patients) and develop policies and procedures that ensure the safety and efficacy of WSI.
Dr. Sayles is the Manager of Anatomic Pathology and Assistant Director of the Pathology Laboratory at SUNY Upstate Medical University in Syracuse, NY. She is a licensed Clinical Laboratory Technologist with 32 years of experience which includes all aspects of histologic technique, optical, fluorescence, confocal and electron microscopy as well as laboratory compliance and regulation. She is currently implementing Whole Slide Imaging (WSI) and Digital Pathology for research and education at Upstate Medical University. She has a masters degree from Hofstra University in biology and chemistry and is an active member of the Clinical Laboratory Management Association. To learn more about Kathleen Sayles and her presentation, please click here.
To learn more about Pathology Visions 2014 or to register now, please click here.
About the Digital Pathology Association
The Digital Pathology Association, located in Indianapolis, IN, was founded in 2009. Its mission is to facilitate education and awareness of digital pathology applications in healthcare and life sciences. Members will be encouraged to share best practices and promote the use of technology among colleagues in order to demonstrate efficiencies, awareness, and its ultimate benefits to patient care. To learn more about the DPA and its members and membership opportunities, please click here.
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