A panel of experts will lend new insights into the evolving regulatory process for digital pathology products at the 2011 Pathology Visions Conference. The regulatory panel session will bring together representatives from the FDA, Centers for Medicare and Medicaid Services (CMS), and College of American Pathologists (CAP) to discuss the regulatory path for digital pathology in the US. The panel discussion will cap off the Digital Pathology Associations’ (DPA) Pathology Visions Conference, which runs from October 30 to November 2 in San Diego.
The panel session will be led by Dr. Stephen Hewitt, NCI, and a member of the 2009 FDA Hematology and Pathology Devices Advisory Panel on Digital Pathology. Each panelist will present and discuss the roles and current thinking of their organizations regarding the evaluation and adoption of digital pathology in its many forms and applications.
The panelists include: Tremel Faison, MS, RAC, SCT (ASCP) representing the FDA Office of In Vitro Diagnostic Device Evaluation and Safety; Walter Henricks, MD, Cleveland Clinic, representing the CAP Laboratory Accreditation Program and the CAP Quality Center Work Group on whole slide imaging systems; and Debra Sydnor representing the CMS Division of Laboratory Services (overseeing CLIA).
“The regulatory panel session at Pathology Visions will provide frank and open discussion of the shared roles pathologists, FDA, CMS, CAP, and device manufacturers must play to allow efficient and effective exploration of the promise of digital pathology for the advancement of medical research and the enhancement of clinical diagnostics,” said Laura M. Ferguson, PhD, Chair of the Digital Pathology Regulatory Task Force and Group Manager Market Strategy, Olympus America Inc.
The Regulatory Panel discussion will be held on the final day of the Pathology Visions Conference, November 2 from noon to 2 pm.
Source: Press release