---
kind: "section"
citation: "21 C.F.R. § 876.5940"
title: "21"
number: "876.5940"
heading: "Orally ingested transient device for constipation."
url: "https://uscodex.org/cfr/21/876.5940"
---

# §876.5940. Orally ingested transient device for constipation.

- (a) **Identification.** An orally ingested transient device for constipation is an electric swallowable capsule that naturally passes through the gastrointestinal tract for the treatment of constipation.
- (b) **Classification.** Class II (special controls). The special controls for this device are:
  - (1) Clinical data must demonstrate the device performs as intended and evaluate the following:
    - (i) Treatment of constipation; and
    - (ii) **All adverse events.**
  - (2) Non-clinical performance data must demonstrate that the device performs as intended under anticipated conditions of use. The following performance characteristics must be tested:
    - (i) Dimensional testing must verify device dimensions;
    - (ii) Performance bench testing must verify functional aspects of the device design;
    - (iii) Leak testing must verify device integrity under worst case clinical conditions;
    - (iv) Bite testing must demonstrate that the device can withstand bite forces;
    - (v) pH resistance testing must evaluate integrity of the capsule when exposed to a physiological relevant range of pH values; and
    - (vi) Bioburden testing must demonstrate the device does not pose an infection risk throughout the labeled shelf life.
  - (3) The patient-contacting components of the device must be demonstrated to be biocompatible.
  - (4) Performance data must support the shelf life of the device by demonstrating continued package integrity and device functionality over the labeled shelf life.
  - (5) Software validation, verification, and hazard analysis must be performed.
  - (6) Electrical safety and electromagnetic compatibility testing must be performed for any electrical components of the device.
  - (7) Labeling for the device must include:
    - (i) A summary of clinical data for the device, including a discussion of adverse events and clinical benefit; and
    - (ii) **A shelf life.**

## Notes

### Amendments

[91 FR 32349, June 1, 2026]

### 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

[91 FR 32349, June 1, 2026]