November 13, 2015
FDA White Oak Campus
Silver Spring, MD
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.
Deadline to register is close of business October 30, 2015. FDA will webcast the workshop.