Business · 18/02/2016Updated: 10/17/2026 · 1 min read
FDA Mandates Premarket Approval for New Metal-on-Metal Hip Joint Systems
Summary
The US Food and Drug Administration (FDA) has issued a final order requiring manufacturers of new metal-on-metal semi-constrained hip joint systems to submit premarket approval applications or product development protocol completion notices before bringing these products to market.
Original source language: Federal Register — Food and Drug AdministrationOpen original release →