---
kind: "section"
citation: "21 C.F.R. § 874.5900"
title: "21"
number: "874.5900"
heading: "External upper esophageal sphincter compression device."
url: "https://uscodex.org/cfr/21/874.5900"
---

# §874.5900. External upper esophageal sphincter compression device.

- (a) **Identification.** An external upper esophageal sphincter compression device is a prescription device used to apply external pressure on the cricoid cartilage for the purpose of reducing the symptoms of laryngopharyngeal reflux disease.
- (b) **Classification.** Class II (special controls). The special controls for this device are:
  - (1) The patient contacting components must be demonstrated to be biocompatible.
  - (2) Non-clinical performance testing must demonstrate that the device performs as intended under anticipated conditions of use. The following performance characteristics must be demonstrated:
    - (i) Mechanical integrity testing (e.g., tensile strength testing, fatigue testing) and
    - (ii) **Shelf life testing.**
  - (3) The technical specifications must include pressure measurement accuracy to characterize device performance.
  - (4) Clinical performance testing must document any adverse events observed during clinical use, and demonstrate that the device performs as intended under anticipated conditions of use.
  - (5) Labeling must include the following:
    - (i) Appropriate warnings and precautions,
    - (ii) A detailed summary of the clinical testing pertinent to use of the device including a detailed summary of the device-related complications or adverse events,
    - (iii) Detailed instructions on how to fit the device to the patient, and
    - (iv) **Instructions for reprocessing of any reusable components.**
  - (6) Patient labeling must be provided and must include:
    - (i) Relevant warnings, precautions, and adverse effects/complications,
    - (ii) Information on how to correctly wear the device,
    - (iii) The potential risks and benefits associated with the use of the device,
    - (iv) Alternative treatments, and
    - (v) **Reprocessing instructions.**

## Notes

### Amendments

[80 FR 46194, Aug. 4, 2015]

### Authority

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

### Source

Source: 51 FR 40389, Nov. 6, 1986, unless otherwise noted.

### Amendments

[80 FR 46194, Aug. 4, 2015]