Radiology Devices; Reclassification of Digital Breast Tomosynthesis System
Built by the Tribune's code from the Federal Register. No AI wrote this page. Published in the Federal Register Aug. 10, 2026. Document 2026-16209. Updated Nov. 7, 2026.
- What it does
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.
The Food and Drug Administration's summary, as published in the Federal Register.
- What it would change
1 part of Title 21 of the Code of Federal Regulations:
- What happens next and when
Either electronic or written comments on the proposed order must be submitted by October 9, 2026. Please see section X of this document for the proposed effective date when the new requirements apply and for the proposed effective date of a final order based on this proposed order.
The agency's dates, word for word.
The record as published
| Document number | 2026-16209 |
|---|---|
| Action | Proposed amendment; proposed order; request for comments. |
| Agencies | Health and Human Services Department; Food and Drug Administration |
| Published | Aug. 10, 2026 |
| Comments close | Oct. 9, 2026 |
| Docket | FDA-2026-N-7630 |
Source: the Federal Register (public domain). The document in the Federal Register