Radiology Devices; Reclassification of Digital Breast Tomosynthesis System
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Document details are published in the U.S. Federal Register; SPEQ surfaces them for reference and is not affiliated with or endorsed by the FDA or the Office of the Federal Register. The authoritative text is on federalregister.gov.
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.
Abstract as published in the Federal Register.
The comment window is still open until October 9, 2026. This is a proposal, and the comment window is the point at which the text is still negotiable — industry input here shapes what the final rule says. Submit comments through the Federal Register document below.
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