Zdrowie i gospodarka · 28/02/2001

FDA Reclassifies Shoulder Joint Prosthesis to Class II with Special Controls

The FDA is reclassifying the shoulder joint metal/polymer/metal nonconstrained or semi-constrained porous-coated uncemented prosthesis from class III to class II, requiring special controls, due to sufficient information on its safety and effectiveness. This decision affects the Orthopedic Surgical Manufacturers Association (OSMA) and is outlined in the FDA's guidance document for class II special controls.