Zdrowie i gospodarka · 17/07/2008

Medical Devices: Radiology Devices; Class II Special Controls Guidance Document: Bone Sonometers; Guidance for Industry and Food and Drug Administration Staff

The Food and Drug Administration (FDA) is announcing the availability of the guidance entitled "Guidance for Industry and FDA Staff; Class II Special Controls Guidance Document: Bone Sonometers." The guidance document describes a means by which bone sonometers may comply with the requirement of special controls for class II devices. Elsewhere in this issue of the Federal Register, FDA is publishing a final rule reclassifying these devices from class III (premarket approval) into class II (special controls).