Zdrowie i gospodarka · 24/10/2017

FDA Classifies Mass Spectrometer System for Clinical Use in Class II (Special Controls) for Identification of Microorganisms

The US Food and Drug Administration (FDA) has classified the mass spectrometer system for clinical use in identifying microorganisms into Class II, requiring special controls to ensure the device's safety and effectiveness, aiming to enhance patient access to innovative devices while reducing regulatory burdens.