---
kind: "section"
citation: "21 C.F.R. § 876.1450"
title: "21"
number: "876.1450"
heading: "Esophageal tissue characterization system."
url: "https://uscodex.org/cfr/21/876.1450"
---

# §876.1450. Esophageal tissue characterization system.

- (a) **Identification.** An esophageal tissue characterization system is a device intended for obtaining measurements of electrical properties within esophageal tissue.
- (b) **Classification.** Class II (special controls). The special controls for this device are:
  - (1) All patient contacting components of the device must be demonstrated to be biocompatible.
  - (2) Performance testing must demonstrate the device can accurately measure the designated electrical characteristics.
  - (3) Mechanical safety testing must demonstrate that the device will withstand forces encountered during use.
  - (4) Software verification, validation, and hazard analysis must be performed.
  - (5) Electromagnetic compatibility and electrical safety, mechanical safety, and thermal safety of the device must be performed.
  - (6) Performance data must validate the reprocessing instructions for any reusable components of the device.
  - (7) Labeling must include:
    - (i) Specific instructions regarding the proper placement and use of the device;
    - (ii) Instructions for reprocessing of any reusable components; and
    - (iii) **An expiration date for single use components.**

## Notes

### Amendments

[86 FR 68399, Dec. 2, 2021]

### Authority

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

### Source

Source: 48 FR 53023, Nov. 23, 1983, unless otherwise noted.

### Amendments

[86 FR 68399, Dec. 2, 2021]