Medical Devices; Radiology Devices; Reclassification of Full Field Digital Mammography System

概要

The Food and Drug Administration (FDA) is proposing to reclassify the full field digital mammography (FFDM) system from class III (premarket approval) to class II (special controls). The device type is intended to produce full field digital x-ray images of the breast. Elsewhere in this issue of the Federal Register, FDA is announcing the availability of the draft guidance document entitled "Class II Special Controls Guidance Document: Full Field Digital Mammography System" that would serve as the special control for the device, if FDA reclassifies this device type.