Bone growth stimulator comments
This article was originally published in The Gray Sheet
Executive Summary
FDA requests feedback on a June 2006 recommendation by the agency's Orthopaedic and Rehabilitation Devices Advisory Panel that noninvasive bone growth stimulator products should not be downclassified from Class III (premarket approval) to Class II (special controls) (1"The Gray Sheet" June 5, 2006, p. 7). Comments are due April 16, according to a Jan. 17 Federal Register notice...