Federal Register #FDA-2026-N-6707

FDA Classifies Opioid Oxygenation Monitor and Hyperhidrosis Skin Patch as Class II Medical Devices

This notice details the FDA's regulatory classification of two medical devices: - Government Buyer: - Food and Drug Administration (FDA), Center for Devices and Radiological Health - OEMs Mentioned: - Masimo Corporation (referenced as the requester for De Novo classification of the Masimo SafetyNet Opioid System) - Products/Devices Classified: - Monitor for opioid induced impairment of oxygenation - Uses sensor hardware and software algorithms to detect arterial oxygen desaturation from opioid overdose - Part number: 868.2250 - Special controls required: clinical performance data, software validation, non-clinical performance testing, usability assessment, biocompatibility evaluation, safety testing, electromagnetic compatibility, and specific labeling (including warnings and clinical validation summaries) - Skin patch for treatment of hyperhidrosis - Classified as a class II device with special controls (no part number provided) - Unique/Notable Requirements: - Devices must meet stringent special controls to ensure safety and effectiveness - Requirements include comprehensive clinical and non-clinical testing, software and usability validation, biocompatibility, and detailed labeling - The classification is regulatory and not a procurement or solicitation for products or services

Description

The Food and Drug Administration (FDA) is classifying the monitor for opioid induced impairment of oxygenation into class II (special controls). This classification aims to ensure safety and effectiveness of the device by applying special controls identified in the order. The action is intended to enhance patient access to innovative devices by reducing regulatory burdens. The device uses sensor hardware and software algorithms to detect desaturations of arterial oxygen saturation resulting from opioid overdose. The classification is effective June 30, 2026, with the classification applicable since March 31, 2023.

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