Zdrowie i gospodarka · 14/11/2017

FDA Classifies Automated Indirect Immunofluorescence Microscope and Software-Assisted System as Class II Device with Special Controls

The US Food and Drug Administration (FDA) has classified the automated indirect immunofluorescence microscope and software-assisted system into Class II, a category requiring special controls to ensure the device's safety and effectiveness, with the goal of increasing patient access to innovative devices and reducing regulatory burdens.