Medical devices; radiology devices; reclassification of bone sonometers. Final rule.
The Food and Drug Administration (FDA) is issuing a final rule to reclassify bone sonometer devices from class III into class II, subject to special controls. FDA is taking this action on its own initiative after reviewing recent scientific and technological studies regarding bone sonometer devices. Elsewhere in this issue of the Federal Register, FDA is announcing the availability of a guidance document entitled "Guidance for Industry and FDA Staff; Class II Special Controls Guidance Document: Bone Sonometers" that will serve as the special control for these devices.
D015519:Bone Density; D001851:Bone Diseases, Metabolic / Q000000981:diagnostic imaging; D018795:Device Approval / Q000331:legislation & jurisprudence; D004869:Equipment Safety / Q000145:classification*; D006801:Humans; D010024:Osteoporosis / Q000000981:diagnostic imaging; D018570:Risk Assessment; D014463:Ultrasonography / Q000145:classification* / Q000295:instrumentation; D014481:United States; D014486:United States Food and Drug Administration