---
kind: "section"
citation: "21 C.F.R. § 882.5060"
title: "21"
number: "882.5060"
heading: "Conditioning tool for eating disorders."
url: "https://uscodex.org/cfr/21/882.5060"
---

# §882.5060. Conditioning tool for eating disorders.

- (a) **Identification.** A conditioning tool for eating disorders is a prescription device that non-invasively measures the mass of food eaten during a meal and provides feedback in the form of eating rate, patient satiety, and eating pattern information to the patient.
- (b) **Classification.** Class II (special controls). The special controls for this device are:
  - (1) Nonclinical performance testing must demonstrate:
    - (i) Device measurement accuracy and repeatability; and
    - (ii) **Device feedback accuracy.**
  - (2) Software verification, validation, and hazard analysis must be performed.
  - (3) The patient-contacting components of the device must be demonstrated to be biocompatible.
  - (4) Performance testing must demonstrate the electromagnetic compatibility (EMC) and electrical safety of the device.
  - (5) Labeling and patient labeling must be provided which includes the following:
    - (i) Information identifying and explaining how to use the device and its components; and
    - (ii) **Information on how the device operates and the typical course of treatment.**

## Notes

### Amendments

[86 FR 68403, Dec. 2, 2021]

### Authority

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

### Source

Source: 44 FR 51730, Sept. 4, 1979, unless otherwise noted.

### Amendments

[86 FR 68403, Dec. 2, 2021]