---
kind: "section"
citation: "21 C.F.R. § 878.4456"
title: "21"
number: "878.4456"
heading: "Hemostatic device for intraluminal gastrointestinal use."
url: "https://uscodex.org/cfr/21/878.4456"
---

# §878.4456. Hemostatic device for intraluminal gastrointestinal use.

- (a) **Identification.** A hemostatic device for intraluminal gastrointestinal use is a prescription device that is endoscopically applied to the upper and/or lower gastrointestinal tract and is intended to produce hemostasis via absorption of fluid or by other physical means.
- (b) **Classification.** Class II (special controls). The special controls for this device are:
  - (1) The device must be demonstrated to be biocompatible.
  - (2) Performance data must support the sterility and pyrogenicity of the device.
  - (3) Performance data must support the shelf life of the device by demonstrating continued sterility, package integrity, and device functionality over the identified shelf life.
  - (4) In vivo performance testing must demonstrate that the device performs as intended under anticipated conditions of use. The testing must evaluate the following:
    - (i) The ability to deliver the hemostatic material to the bleeding site;
    - (ii) The ability to achieve hemostasis in a clinically relevant model of gastrointestinal bleeding; and
    - (iii) Safety endpoints, including thromboembolic events, local and systemic toxicity, tissue trauma, gastrointestinal tract obstruction, and bowel distension and perforation.
  - (5) Non-clinical performance testing must demonstrate that the device performs as intended under anticipated conditions of use. The following performance characteristics must be evaluated:
    - (i) Materials characterization of all components must demonstrate the device meets established specifications, which must include compositional identity and purity, characterization of impurities, physical characteristics, and reactivity with fluids.
    - (ii) Performance testing must demonstrate the mechanical integrity and functionality of the system used to deliver the device and demonstrate the device meets established specifications, including output pressure for propellant-based systems.
  - (6) Labeling must include:
    - (i) Information identifying and explaining how to use the device and its components; and
    - (ii) **A shelf life.**

## Notes

### Amendments

[83 FR 52971, Oct. 19, 2018]

### Authority

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

### Source

Source: 53 FR 23872, June 24, 1988, unless otherwise noted.

### Amendments

[83 FR 52971, Oct. 19, 2018]