Radiology Devices; Reclassification of Digital Breast Tomosynthesis System
Updated 5 hours ago ()
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; CISA 1: Information System Auditing Process
- Source record id
- 2026-16209
- First seen by InfoSec Signals
- Sep 23, 2026
Source: Federal Register API, Office of the Federal Register, National Archives and Records Administration about this source more from it
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