Hip prosthesis reclassification
This article was originally published in The Gray Sheet
Executive Summary
FDA formalizes reclassification from Class III to Class II of metal/polymer/metal semi-constrained porous-coated uncemented hip prostheses in a Jan. 8 Federal Register notice. This past February, FDA sent letters announcing its intent to downclassify the devices to Richards Medical and Intermedics Orthopedics, which submitted the original downclassification petition ("The Gray Sheet" March 9, p. 9)....