Zdrowie i gospodarka · 15/02/2006

Medical Devices; Radiology Devices; Reclassification of Bone Sonometers

The Food and Drug Administration (FDA) is publishing a proposed rule to reclassify bone sonometer devices from class III into class II, subject to special controls. A bone sonometer is a device that transmits ultrasound energy into the human body to measure acoustic properties of bone that indicate overall bone health and fracture risk. Elsewhere in this issue of the Federal Register, FDA is announcing the availability of a draft guidance document entitled "Class II Special Controls Guidance Document: Bone Sonometers" that the agency proposes to use as a special control for these devices.