// AI news · 2026-10-30 · Federal Register
FDA Classifies Sleep Apnea Risk Device as Class II
The FDA classifies an over-the-counter device for sleep apnea risk assessment as Class II with special controls, effective October 30, 2026.
Published 2026-10-30 12:00 (Beijing time)Source Federal RegisterAuto-summarised, fact-checked against source
01Summary
The classification was applicable from February 6, 2024. Special control measures are included in the codified language and aim to ensure safety and effectiveness while improving patient access to innovative devices.
Summarised from the original article by an open-source model, then checked automatically: every number and English name must appear in the source. The original article is authoritative.
02Key points
- FDA classifies sleep apnea risk assessment device as Class II with special controls
- Effective date: October 30, 2026; applicable from February 6, 2024
- Special controls are incorporated into codified regulatory language
- Classification supports safety, effectiveness, and patient access
03Source
Federal Register · published 2026-10-30 12:00 Beijing time
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