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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.

Metadata

FieldValue
Federal Register2026-16209
AgenciesFood and Drug Administration, Health and Human Services Department
Publication2026-08-10
Comment closes2026-10-09

Overview

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 classifi…

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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.

CFA analysis and draft

No draft comment is stored for this docket in the current export.

Technical details
  • report_type: fr-proposed-rules
  • persona: all
  • Source field for draft body: comment_draft_markdown

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