Federal Register #2026-13140

FDA Classifies Monitors for Opioid-Induced Oxygenation Impairment as Class II Devices

This FDA final order establishes the regulatory classification for monitors designed to detect opioid-induced impairment of oxygenation. - Government Buyer: - Department of Health and Human Services (HHS) - Food and Drug Administration (FDA) - OEMs and Vendors: - Masimo Corporation (requester for De Novo classification) - Products/Services: - Monitors for opioid induced impairment of oxygenation - Example: Masimo SafetyNet Opioid System - Devices use sensor hardware and software algorithms to detect arterial oxygen desaturation from opioid overdose - Unique/Notable Requirements: - Devices are classified as class II medical devices with special controls - Special controls include: - Clinical performance data - Software validation - Non-clinical performance testing - Usability assessment - Biocompatibility evaluation - Safety testing - Specific labeling requirements - No procurement or solicitation for products or services is announced in this notice; this is a regulatory classification action.

Description

The Food and Drug Administration (FDA) is classifying the monitor for opioid induced impairment of oxygenation into class II with special controls. This device uses sensor hardware and software algorithms to detect desaturations of arterial oxygen saturation resulting from opioid overdose. The classification aims to provide reasonable assurance of safety and effectiveness while reducing regulatory burdens and enhancing patient access to innovative devices. Special controls include clinical performance data, software validation, non-clinical performance testing, usability assessment, biocompatibility evaluation, safety testing, and specific labeling requirements.

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