Federal Register #FDA-2026-N-7630

FDA proposes reclassification of Digital Breast Tomosynthesis Systems from Class III to Class II medical devices

The Food and Drug Administration (FDA), part of the Department of Health and Human Services, is proposing a regulatory change affecting digital breast tomosynthesis (DBT) systems. - Government Buyer: - Food and Drug Administration (FDA) - Center for Devices and Radiological Health - Products/Services Requested: - Digital Breast Tomosynthesis System (product code OTE) - Prescription device for generating digital cross-sectional x-ray images of the breast - Includes acquisition hardware/software, image receptor, workstation, exposure control, image processing, compression system, and support devices - OEMs and Vendors: - No specific OEMs or vendors named; applies to all manufacturers of DBT systems - Unique/Notable Requirements: - Proposed reclassification from Class III (premarket approval) to Class II (special controls) - New special controls include: - Performance testing - Clinical image evaluation - Software validation - Biocompatibility - Labeling requirements - Intended to reduce regulatory burden and improve patient access - FDA is seeking public comments on the proposed rule - Impact: - All manufacturers of DBT systems will be affected by new regulatory requirements - No procurement of specific products or services; this is a regulatory change proposal

Description

The Food and Drug Administration (FDA) is proposing to reclassify digital breast tomosynthesis (DBT) systems, product code OTE, from class III (premarket approval) to class II (special controls), subject to premarket notification. The proposal includes a new device classification regulation named "Digital Breast Tomosynthesis System" to identify these devices and establish special controls necessary to ensure their safety and effectiveness. The reclassification is based on data from original PMAs, panel deliberations, peer-reviewed literature, and FDA databases. Comments on the proposed order must be submitted by October 9, 2026.

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