---
kind: "section"
citation: "21 C.F.R. § 876.5982"
title: "21"
number: "876.5982"
heading: "Ingested, transient, space occupying device for weight management and/or weight loss."
url: "https://uscodex.org/cfr/21/876.5982"
---

# §876.5982. Ingested, transient, space occupying device for weight management and/or weight loss.

- (a) **Identification.** This device is an ingested material that transiently occupies space in the stomach. The device passes from the body via the natural gastrointestinal tract.
- (b) **Classification.** Class II (special controls). The special controls for this device are:
  - (1) The patient-contacting components of the device must be demonstrated to be biocompatible for its intended use.
  - (2) Non-clinical performance testing must demonstrate that the device performs as intended under anticipated conditions for use, as follows:
    - (i) Performance bench testing in a simulated use model must evaluate device disintegration and device hydration state throughout the gastrointestinal tract;
    - (ii) Bioburden and moisture content assessments must evaluate device infection risk throughout the labeled shelf life; and
    - (iii) Performance data must support the shelf life of the device by demonstrating continued package integrity and device functionality over the labeled shelf life.
  - (3) Clinical performance testing must demonstrate the device performs as intended and evaluate the following:
    - (i) Weight change;
    - (ii) All adverse events, including obstruction, dilation, diarrhea, constipation, and dehydration; and
    - (iii) **Interaction with representative medications.**
  - (4) Physician and patient device labeling must state:
    - (i) The clinical benefit of the device as assessed by using percent total body weight loss;
    - (ii) Treatment must be offered in combination with diet and exercise;
    - (iii) Instructions on how to use the device as intended including how to avoid interaction with medication; and
    - (iv) **The shelf life of the device.**

## Notes

### Amendments

[86 FR 70372, Dec. 10, 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 70372, Dec. 10, 2021]