Business · 30/06/2026
FDA Classifies Anesthesiology Device for Opioid-Induced Impairment of Oxygenation
The FDA has classified the monitor for opioid-induced impairment of oxygenation into Class II, a move aimed at ensuring the device's safety and effectiveness while reducing regulatory burdens, ultimately enhancing patients' access to innovative devices.
Original source language: Federal Register — Health and Human ServicesOpen original release →