# Federal Register #2026-22182

FDA Class II classifications for sleep apnea, spinal imaging, and skin-lesion devices

**Buyer:** Food and Drug Administration
**Posted:** October 30, 2026
**Identifier:** 2026-22182

The FDA issued medical-device classification orders; the supplied material describes regulatory actions, not a procurement opportunity.
- **Government agency:** U.S. Department of Health and Human Services, Food and Drug Administration (FDA); no specific office is identified.
- **Named companies:** **Samsung Electronics Co., Ltd.** requested De Novo classification for its Sleep Apnea Feature; **DermaSensor Inc.** is named as the requester for a physician-used skin-lesion diagnostic device. No manufacturer is identified for the spinal imaging system.
- **Devices covered:**
  - Over-the-counter sleep apnea risk assessment device: analyzes sensor signals and notifies users of risk; it is not intended to diagnose sleep apnea or replace traditional diagnostic methods. Class II with special controls and subject to 510(k) requirements.
  - Spinal imaging system for neuraxial procedures: uses sensors and software to help identify the interspinous space. Class II with special controls.
  - Physician-used software-aided adjunctive diagnostic device for lesions suspicious for skin cancer: identified as a Class II device; further specifications are not included in the supplied material.
- **Notable requirements:** For the sleep apnea device, controls include clinical and nonclinical performance evidence, software verification and validation, hazard analysis, usability and hardware safety testing, biocompatibility evaluation for skin-contacting components, and labeling on outputs, limitations, compatible hardware, and when to seek medical care.
- **Procurement details:** No quantities, part numbers, requested services, contract value, or contract performance period are stated.

### Description

The FDA classifies the over-the-counter device to assess risk of sleep apnea as a class II device subject to special controls. The device is intended to notify users who have not previously been diagnosed with sleep apnea about their risk, using software algorithms to analyze sensor signals; it is not intended to diagnose sleep apnea or replace traditional diagnostic methods. The final order codifies the classification and specifies controls covering clinical and non-clinical performance, safety, software, usability, biocompatibility, and labeling. The order is effective October 30, 2026, and the classification was applicable on February 6, 2024.

[View original listing](https://www.federalregister.gov/documents/2026/10/30/2026-22182/medical-devices-anesthesiology-devices-classification-of-the-over-the-counter-device-to-assess-risk)