# Radiology Devices; Reclassification of Digital Breast Tomosynthesis System

**Action Urgency Score:** 20/100

| Field | Value |
|---|---|
| Agency | Health and Human Services Department; Food and Drug Administration |
| Type | Proposed rule |
| Action | Proposed amendment; proposed order; request for comments. |
| Published | 2026-08-10 |
| Comments close | 2026-10-09 |
| Significant | No |
| CFR parts | 21 CFR 892 |
| Summary | 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. |
| Document number | 2026-16209 |

## Why this score


Source: Federal Register API (Office of the Federal Register) (https://www.federalregister.gov/documents/2026/08/10/2026-16209/radiology-devices-reclassification-of-digital-breast-tomosynthesis-system). Last refreshed: 2026-11-04T21:40:49.974Z.
Data from the Federal Register API; the published Federal Register document is authoritative. Informational only, not legal advice.