Business · 06/09/2001

FDA Proposes to Reclassify Hip Joint Metal/Polymer Prostheses from Class III to Class II

The Food and Drug Administration (FDA) is proposing to reclassify the hip joint metal/polymer constrained cemented or uncemented prosthesis from class III (premarket approval) to class II (special controls), based on new information submitted by the Orthopedic Surgical Manufacturers Association, and will publish a final regulation after considering public comments.