Bone density meters get easier path to market
This article was originally published in The Gray Sheet
Executive Summary
Bone sonometer devices, which transmit ultrasound energy into bone to determine fracture risk, are down-classified to 510(k) status, FDA says in a July 17 final rule. FDA initiated the reclassification process in February 2006 based on evolving evidence. The final special controls 1guidance, superseding the 2006 draft and a 2001 guidance on PMA submissions for bone sonometers, describes measures to mitigate risks such as electrical hazards, electromagnetic interference and tissue damage