FOOD AND DRUG ADMINISTRATION ISSUES PROPOSED RULE: RADIOLOGY DEVICES; RECLASSIFICATION OF DIGITAL BREAST TOMOSYNTHESIS SYSTEM

WASHINGTON, Aug. 10 -- Food and Drug Administration has issued a proposed rule called: Radiology Devices; Reclassification of Digital Breast Tomosynthesis System.

The proposed rule was published in the Federal Register on Aug. 10 by Grace R. Graham, Deputy Commissioner for Policy, Legislation, and International Affairs.

Summary: 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...