Regulatory Deadline Board/2026-16209
Food and Drug Administration · Proposed Rule
Radiology Devices; Reclassification of Digital Breast Tomosynthesis System
Closed 20 days ago
In plain English
FDA proposed moving digital breast tomosynthesis systems (OTE) from class III to class II with special controls and 510(k).
Who it hits
Breast imaging OEMs, radiology groups, and AI vendors that sit on DBT systems.
- Agency
- Food and Drug Administration
- Document type
- Proposed Rule
- Published
- Aug 10, 2026
- Comments close
- Oct 9, 2026
- Status
- Closed 20 days ago
- Federal Register number
- 2026-16209
- Docket
- Docket No. FDA-2026-N-7630
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