Business · 16/04/2026
FDA Classifies Manual Surgical Instrument for Orthopedic Implant into Class II
The FDA is classifying the manual surgical instrument for appropriate patient selection for orthopedic implant into class II, citing a reasonable assurance of safety and effectiveness, and aims to reduce regulatory burdens, thereby enhancing patients' access to innovative devices.
Original source language: Federal Register — Food and Drug AdministrationOpen original release →