Radiology Devices; Reclassification of Digital Breast Tomosynthesis System

The Food and Drug Administration (FDA) is proposing to reclassify digital breast tomosynthesis (DBT) systems, product code OTE, which are postamendments class III devices, from class III (premarket approval) into class II (special controls), subject to premarket notification. FDA is also proposing a new device classification regulation with the name "Digital Breast Tomosynthesis System," to identify these devices along with special controls that FDA believes are necessary to provide a reasonable assurance of the safety and effectiveness of these devices.

Tags

health IT, Proposed Rule, Health and Human Services Department, Food and Drug Administration

Related exam domains

CISSP 8: Software Development Security; CISM 3: Information Security Program; CISM 4: Incident Management

Source record id

2026-16209

First seen by InfoSec Signals

9/23/2026

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