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US FDA reclassifies bone sonometers

This article was originally published in Clinica

Executive Summary

The US FDA has published a final rule reclassifying bone sonometers from class III to class II devices, requiring special controls. A guidance document outlining the special controls for the devices has been published at the same time. For a copy of the guidance, go to http://www.fda.gov/cdrh/ode/guidance/1547.html

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