Business · 26/09/2014

FDA Releases Draft Guidance for Early Growth Response 1 Gene Fluorescence In-Situ Hybridization Test System

The FDA has made available a draft guidance document outlining the recommended format and content for abbreviated 510(k) submissions for early growth response 1 (EGR1) gene fluorescence in-situ hybridization (FISH) test systems used in specimen characterization devices.