2026-22182·DEPARTMENT OF HEALTH AND HUMAN SERVICES

Medical Devices; Anesthesiology Devices; Classification of the Over-the-Counter Device To Assess Risk of Sleep Apnea

Final RuleEffective

Published: Oct 30, 2026
Effective: Oct 30, 2026
Citation: 91 FR 68462
Docket: Docket No. FDA-2026-N-12385
Agencies: DEPARTMENT OF HEALTH AND HUMAN SERVICES, Food and Drug Administration

Final amendment; final order.

Summary

The Food and Drug Administration (FDA) has officially placed over‑the‑counter devices that screen users for the risk of sleep apnea into “class II” – a category that requires manufacturers to meet specific performance standards, known as special controls. The agency says this classification will help ensure the devices are safe and work as intended while still allowing people easier access to new, useful products. The rule is issued by the U.S. Department of Health and Human Services, through the FDA, and it applies to companies that make, market, or sell these sleep‑apnea screening devices to consumers without a prescription. By meeting the listed special controls, manufacturers can continue selling their products directly to the public. The regulation took effect on October 30, 2026, the same day it was published in the Federal Register (91 FR 68462). Because it is a final rule, there is no additional public comment period; manufacturers must now comply with the class II requirements, and the FDA will monitor the market to confirm that the devices remain safe and effective.

AI-generated summary — verify against the Federal Register text.

Official abstract

The Food and Drug Administration (FDA) is classifying the over-the-counter device to assess risk of sleep apnea 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 over-the-counter device to assess risk of sleep apnea. We are taking this action because we have determined that classifying the device into class II will provide a reasonable assurance of the 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.