Data / Federal rules / 2026-16209
Radiology Devices; Reclassification of Digital Breast Tomosynthesis System
The Food and Drug Administration published this proposed rule in the Federal Register on August 10, 2026. Comments closed on October 9, 2026.
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What the agency says
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.
Key facts
- Document number
- 2026-16209
- Type
- Proposed rule
- Action
- Proposed amendment; proposed order; request for comments
- Agency
- Health and Human Services Department; Food and Drug Administration
- Published
- August 10, 2026
- Comments due
- October 9, 2026
- Dates
- 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.
- Docket
- Docket No. FDA-2026-N-7630
- Code of Federal Regulations
- 21 CFR 892
- Topics
- Medical devices; Radiation protection; X-rays
- Pages
- 11
Other documents from the Food and Drug Administration
Everything from the Food and Drug Administration · Rules on medical devices · Rules on radiation protection · Rules on x-rays · Published in August 2026
Read from the Federal Register API, last updated 2026-10-23. The document on federalregister.gov is the official record; dates and dockets can change through later corrections. Free to reuse with credit to SpecStream under CC BY 4.0.