CDRH Industry: Content and Format for Abbreviated 510(k)s for Early Growth Response 1 (EGR1) Gene Fluorescence In-Situ Hybridization (FISH) Test System for Specimen Characterization Devices - Draft Guidance for Industry and FDA Staff

A draft guidance has been posted titled, "Content and Format for Abbreviated 510(k)s for Early Growth Response 1 (EGR1) Gene Fluorescence In-Situ Hybridization (FISH) Test System for Specimen Characterization Devices."  FDA is issuing this guidance to provide industry and agency staff with recommendations for 100 the suggested format and content of an Abbreviated 510(k) submission for early growth 101 response 1 (EGR1) gene fluorescence in-situ hybridization (FISH) test system for specimen 102 characterization devices and recommendations for addressing certain labeling issues relevant 103 to the review process specific to these devices.  To view the draft guidance, please see: http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/UCM416131.pdf