Radiology Devices; Reclassification of Digital Breast Tomosynthesis System
The comment period closed Oct 9, 2026.
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 identi
Summary from the Federal Register.
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Full history
- Aug 10, 2026
Rule published
Radiology Devices; Reclassification of Digital Breast Tomosynthesis System
Health and Human Services Department
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