Zdrowie i gospodarka · 27/12/2017

FDA Classifies Flow Cytometric Test System for Hematopoietic Neoplasms into Class II Special Controls

The FDA has classified the flow cytometric test system for hematopoietic neoplasms into Class II, which includes special controls, to ensure the device's safety and effectiveness, and to reduce regulatory burdens, ultimately enhancing patients' access to innovative devices.