Zdrowie i gospodarka · 22/01/2020

FDA Reclassifies Medical Image Analyzers for Mammography and Other Medical Imaging Applications

The Food and Drug Administration (FDA) is issuing a final order to reclassify medical image analyzers used for breast cancer detection and other medical imaging applications from Class III to Class II, subject to premarket notification. The FDA is also identifying special controls to ensure the devices provide a reasonable assurance of safety and effectiveness.