Business · 25/10/2019
FDA Classifies Orthopedic Surgical Instrumentation for Osteochondral Implants
The FDA has classified orthopedic surgical instrumentation designed for osteochondral implants with press-fit fixation into Class II, requiring special controls to ensure safety and effectiveness, aiming to enhance patient access to innovative devices.
Original source language: Federal Register — Food and Drug AdministrationOpen original release →