The Food and Drug Administration (FDA) is announcing a public workshop entitled: “Use of Databases for Establishing the Clinical Relevance of Human Genetic Variants”. The purpose of this workshop is to obtain feedback on ways in which FDA can use curated databases containing information about human genetic variation as sources of valid clinical evidence for the Agency’s oversight of the next-generation sequencing (NGS)-based in vitro diagnostic tests (IVDs). Comments and suggestions generated through this workshop will guide the development of best practices and/or regulatory standards for reliance on external curated databases.
For more information and registration, please see: http://www.fda.gov/
MedicalDevices/NewsEvents/ WorkshopsConferences/ ucm459450.htm