---
kind: "section"
citation: "21 C.F.R. § 872.5571"
title: "21"
number: "872.5571"
heading: "Auto titration device for oral appliances."
url: "https://uscodex.org/cfr/21/872.5571"
---

# §872.5571. Auto titration device for oral appliances.

- (a) **Identification.** An auto-titration device for oral appliances is a prescription home use device that determines a target position to be used for a final oral appliance for the reduction of snoring and mild to moderate obstructive sleep apnea.
- (b) **Classification.** Class II (special controls). The special controls for this device are:
  - (1) Clinical performance testing must evaluate the following:
    - (i) Performance characteristics of the algorithm; and
    - (ii) **All adverse events.**
  - (2) Non-clinical performance testing must demonstrate that the device performs as intended under anticipated conditions for use, including the following:
    - (i) Validation of the closed loop algorithm;
    - (ii) Mechanical integrity over the expected use life;
    - (iii) Characterization of maximum force, distance, and speed of device movement; and
    - (iv) **Movement accuracy of intraoral components.**
  - (3) Performance testing must demonstrate the wireless compatibility, electrical safety, and electromagnetic compatibility of the device in its intended use environment.
  - (4) Software verification, validation, and hazard analysis must be performed.
  - (5) The patient-contacting components of the device must be demonstrated to be biocompatible.
  - (6) Performance data must validate the reprocessing instructions for any reusable components.
  - (7) Patient labeling must include:
    - (i) Information on device use, including placement of sensors and mouthpieces;
    - (ii) A description of all alarms; and
    - (iii) **Instructions for reprocessing any reusable components.**
  - (8) A human factors assessment must evaluate simulated use of the device in a home use setting.

## Notes

### Amendments

[84 FR 5000, Feb. 20, 2019]

### Authority

Authority: 21 U.S.C. 351, 360, 360c, 360e, 360j, 360 l, 371.

### Source

Source: 52 FR 30097, Aug. 12, 1987, unless otherwise noted.

### Amendments

[84 FR 5000, Feb. 20, 2019]