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Radiology Devices; Reclassification of Digital Breast Tomosynthesis System
Read on FederalRegister.gov · Official PDF · Docket on Regulations.gov · Add to calendar (.ics)
Summary (from the Federal Register abstract)
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 type
- Proposed Rule
- Federal Register document number
- 2026-16209
- Published
- Aug 10, 2026
- Action
- Proposed amendment; proposed order; request for comments.
- Docket
- FDA-2026-N-7630
- Comments posted on Regulations.gov (at last check)
- 8
- CFR parts
- 21 CFR 892
- DATES section (from the document)
- 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.
- Topics (auto-tagged)
- Medical devices
Source: Federal Register API, document 2026-16209. Federal Register text is a U.S. government work. Confirm dates in the official document; later documents may extend, reopen or correct them.