Federal Register #FDA2026N7630

FDA Regulatory Proposal: Reclassification of Digital Breast Tomosynthesis Systems

This opportunity concerns a proposed regulatory change by the Food and Drug Administration (FDA) impacting manufacturers of digital breast tomosynthesis (DBT) systems. - Government Buyer: - Food and Drug Administration (FDA), Department of Health and Human Services - Center for Devices and Radiological Health - Products/Services Affected: - Digital Breast Tomosynthesis Systems (product code OTE) - Devices generate digital cross-sectional x-ray images for breast cancer screening and diagnosis - Includes acquisition hardware/software, image receptor, workstation, exposure control, image processing, compression system, patient/equipment support devices - OEMs and Vendors: - No specific OEMs or vendors named; applies to all manufacturers of DBT systems - Unique/Notable Requirements: - Reclassification from class III (premarket approval) to class II (special controls) - New device classification regulation for DBT systems - Special controls include performance testing, clinical image evaluation, software validation, biocompatibility, and labeling requirements - Regulatory action, not a procurement; FDA invites public comments - Impact: - Reduces regulatory burden and improves patient access - Affects all current and future manufacturers of DBT systems

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. This reclassification aims to provide reasonable assurance of safety and effectiveness through special controls. The FDA is also proposing a new device classification regulation named "Digital Breast Tomosynthesis System" to identify these devices and establish necessary special controls. Public comments on the proposed order are invited until October 9, 2026.

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