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