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.
What this item does
The short version, using the agency's own summary text.
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.
Proposed amendment; proposed order; request for comments.
Important dates
The dates that matter most for this item.
Published
August 10, 2026
Comment deadline
October 9, 2026
Federal rulebook sections mentioned
These are the parts of the Code of Federal Regulations cited in the filing.