Zdrowie i gospodarka · 10/08/2026

FDA Proposes Reclassification of Digital Breast Tomosynthesis Systems

The Food and Drug Administration (FDA) is proposing to reclassify digital breast tomosynthesis (DBT) systems, product code OTE, from class III (premarket approval) into class II (special controls), subject to premarket notification. The FDA aims to establish a new device classification regulation, titled Digital Breast Tomosynthesis System, to identify these devices along with necessary special controls for ensuring their safety and effectiveness.