Zdrowie i gospodarka · 09/05/2007

FDA Classifies Gene Expression Profiling Test Systems for Breast Cancer Prognosis Under Class II Special Controls

The FDA is classifying gene expression profiling test systems for breast cancer prognosis into Class II, special controls, with the guidance document 'Class II Special Controls Guidance Document: Gene Expression Profiling Test System for Breast Cancer Prognosis' serving as the special control, to ensure the safety and effectiveness of these devices.