21 CFR 868.2378 — Over-The-Counter Device To Assess Risk Of Sleep Apnea
Anesthesiology (AN) · Part 868 Subpart C—Monitoring Devices · § 868.2378
Identification
An over-the-counter (OTC) software-only, mobile medical application operating on a compatible Samsung Galaxy Watch and Phone. It is intended to detect signs of moderate to severe obstructive sleep apnea in the form of significant breathing disruptions in adult users 22 years and older, over a two-night monitoring period. It uses software algorithms to analyze input sensor signals (PPG and actigraphy) to provide a risk assessment for sleep apnea. It is not intended to provide a standalone diagnosis, replace traditional methods of diagnosis (e.g., polysomnography), assist clinicians in diagnosing sleep disorders, or be used as an apnea monitor.
Classification Rationale
Class II (special controls). The device is subject to the general controls of the FD&C Act and the identified special controls.
Product Codes
| Product Code | Device Name | Class | Devices | Attributes |
|---|---|---|---|---|
| QZW | Over-The-Counter Device To Assess Risk Of Sleep Apnea | 2 | 2 | SaMD |
Special Controls
QZW — Over-The-Counter Device To Assess Risk Of Sleep Apnea
In combination with the general controls of the FD&C Act, the over-the-counter device to assess risk of sleep apnea is subject to the following special controls:
De Novo Order DEN230041
