Zdrowie i gospodarka · 08/07/2016

FDA Releases Draft Guidance on Using Public Human Genetic Variant Databases for NGS-Based In Vitro Diagnostics

The Food and Drug Administration (FDA) has released a draft guidance document outlining how publicly accessible databases of human genetic variants can be used to support the clinical validity of next generation sequencing (NGS)-based in vitro diagnostics. The FDA is seeking recognition of these databases and will review applications from administrators to ensure their validity.