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www.fdanews.com/articles/84548-fda-releases-proposed-rule-for-bone-sonometer-reclassification

FDA RELEASES PROPOSED RULE FOR BONE SONOMETER RECLASSIFICATION

February 14, 2006

The FDA is publishing a proposed rule to reclassify bone sonometer devices form Class III to Class II, subject to special controls. A bone sonometer device transmits ultrasound energy into the human body to measure acoustic properties of bone that indicate overall bone health and fracture risk.

The FDA is announcing the availability of a draft guidance document entitled "Class II Special Controls Guidance Document: Bone Sonometers" that the agency proposes to use as a special control for these devices.

This reclassification is based on experience with the device and information on the benefits and risks of the device that have developed since the device's classification into Class III. Furthermore, sonometers from many different manufacturers have demonstrated similar performance, which increases the agency's confidence in this technology.

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