# 2026-13140: FDA Downgrades Opioid Oxygen Monitor to Class II

2026-13140, Medical Devices; Anesthesiology Devices; Classification of the Monitor for Opioid Induced Impairment of Oxygenation, is a Federal Register rule from Health and Human Services Department, Food and Drug Administration published 2026-06-30, effective 2026-06-30; PRIA reads it as touching household money (as of 2026-07-07).

- Canonical: https://policyrisk.com/federal-register/2026-13140
- As of: 2026-07-07
- Plain-text twin of the page above; the HTML and this file carry the same facts.

## Facts
- Document number: 2026-13140
- Title: Medical Devices; Anesthesiology Devices; Classification of the Monitor for Opioid Induced Impairment of Oxygenation
- Type: Rule
- Agencies: Health and Human Services Department; Food and Drug Administration
- Citation: 91 FR 39459
- Published: 2026-06-30
- Effective: 2026-06-30
- Comments close: not stated
- Significant: no
- Touches household money: yes
- Regulation identifier numbers: none
- Last updated: 2026-07-07

## In one line

FDA Downgrades Opioid Oxygen Monitor to Class II

## Summary

The FDA is officially putting the monitor for opioid-induced oxygen problems into a safer, easier-to-manage category called Class II. This change helps make sure the device works well and is safe, while also speeding up patient access to this important tech. The new rules took effect on June 30, 2026, and could lower costs and delays for companies making these monitors.

## Abstract

The Food and Drug Administration (FDA) is classifying the monitor for opioid induced impairment of oxygenation into class II (special controls). The special controls that apply to the device type are identified in this order and will be part of the codified language for classification of the monitor for opioid induced impairment of oxygenation. We are taking this action because we have determined that classifying the device into class II will provide a reasonable assurance of safety and effectiveness of the device. We believe this action will also enhance patients' access to beneficial innovative devices, in part by reducing regulatory burdens.

## Effects PRIA read

- Class II Reclassification Speeds Access: benefit, medium. FDA has classified the monitor for opioid-induced impairment of oxygenation as Class II (special controls). This final order is effective June 30, 2026 (and the classification was applicable on March 31, 2023), and FDA says the change provides reasonable assurance of safety and effectiveness while…
- Easier Route to Market for Makers: benefit, medium. Because FDA placed this monitor into Class II via the De Novo process, the device can serve as a predicate for future devices so other sponsors can use the less burdensome 510(k) pathway instead of De Novo or premarket approval. FDA states this will enhance patient access in part by reducing regula…
- Special Controls Require Testing and Documentation: cost, medium. Manufacturers of these monitors must meet detailed special controls, including clinical performance data (accuracy, sensitivity, specificity), software verification and validation with hazard analysis, non-clinical sensor performance testing, usability assessment, biocompatibility, and electromagne…
- Labels Must Include Overdose Warnings and Info: benefit, medium. Labeling for these monitors must include a summary of clinical validation (including sensitivity, specificity, positive and negative predictive values by subpopulation), principles of sensor operation, information on preventing, recognizing, and treating an overdose, warnings that the device may no…

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## Sources
- [2026-13140 on federalregister.gov](https://www.federalregister.gov/documents/2026/06/30/2026-13140/medical-devices-anesthesiology-devices-classification-of-the-monitor-for-opioid-induced-impairment)
- [2026-13140 as published (PDF)](https://www.govinfo.gov/content/pkg/FR-2026-06-30/pdf/2026-13140.pdf)

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Source: PRIA, https://policyrisk.com/federal-register/2026-13140 (as of 2026-07-07).