CDRH Industry: Public Workshop - Standards Based Approach to Analytical Performance Evaluation of Next Generation Sequencing In Vitro Diagnostic Tests, November 12, 2015

The Food and Drug Administration (FDA) is announcing a public workshop entitled “Standards Based Approach to Analytical Performance Evaluation of Next Generation Sequencing In Vitro Diagnostic Tests.” The purpose of this workshop is to obtain feedback on possible analytical standards and approaches to develop or build on existing standardization efforts in order to optimize FDA’s regulation of next-generation sequencing (NGS)-based in vitro diagnostic tests. Comments and suggestions generated through this workshop will also guide the use of regulatory science to advance the further development of appropriate and relevant performance standards for evaluation of next generation sequencing in vitro diagnostic tests that produce results on variation in the human genome.

For more information and registration, please see: http://www.fda.gov/MedicalDevices/NewsEvents/WorkshopsConferences/ucm459449.htm