Federal Register: FDA Issues Proposed Amendment, Proposed Order, Request for Comments on Reclassifying Digital Breast Tomosynthesis Systems
August 09, 2026
August 09, 2026
WASHINGTON, Aug. 9 (TNSFR) -- The U.S. Department of Health and Human Services Food and Drug Administration issued the following action in the Federal Register.
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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 into class II, subject to premarket notification. FDA is also proposing a new device classification regulation with the . . .
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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 into class II, subject to premarket notification. FDA is also proposing a new device classification regulation with the . . .