Zdrowie i gospodarka · 17/01/2007
Orthopedic Devices; Reclassification of Non-Invasive Bone Growth Stimulator
The Food and Drug Administration (FDA) is issuing for public comment the recommendation of the Orthopaedic and Rehabilitation Devices Panel to deny a petition to reclassify the non-invasive bone growth stimulator from class III to class II. The Panel made this recommendation after reviewing the reclassification petition submitted by RS Medical Corp., as well as consideration of presentations made at the Panel meeting by the petitioner, FDA, and members of the public. FDA is also issuing for public comment its findings on the Panel's recommendation. After considering any public comments on the Panel's recommendation and FDA's findings, FDA will approve or deny the reclassification petition by order in the form of a letter to the petitioner. FDA's decision on the reclassification petition will be announced in the Federal Register.