← All comment items
Open for comment Health and Human Services Department, Food and Drug Administration Docket Docket No. FDA-2026-N-7630

FDA Proposes Reclassifying Digital Breast Tomosynthesis Systems from Class III to Class II

💬 Comments close in 54 days (Oct 9)

Timeline

  1. Proposed / opened

    FDA Proposes Reclassifying Digital Breast Tomosynthesis Systems from Class III to Class II

  2. Related document

    Radiology Devices; Reclassification of Digital Breast Tomosynthesis System

Briefs in this proceeding

Notable FDA 💬 Comments close in 54 days (Oct 9)

FDA Proposes Reclassifying Digital Breast Tomosynthesis Systems from Class III to Class II

FDA's proposal would reduce regulatory burden for DBT systems by moving them from premarket approval to special controls with 510(k) pathway, while establishing new device classification and safety requirements. The Food and Drug Administration (FDA) is proposing to reclassify digital breast...

Sources

Health and Human Services Department, Food and Drug Administration · Radiology Devices; Reclassification of Digital Breast Tomosynthesis System · Aug 10