---
kind: "section"
citation: "21 C.F.R. § 878.4454"
title: "21"
number: "878.4454"
heading: "Non-absorbable, hemostatic gauze for temporary internal use."
url: "https://uscodex.org/cfr/21/878.4454"
---

# §878.4454. Non-absorbable, hemostatic gauze for temporary internal use.

- (a) **Identification.** A non-absorbable, hemostatic gauze for temporary internal use is a prescription device intended to be placed temporarily for control of severely bleeding wounds such as surgical wounds and traumatic injuries. The gauze is coated or impregnated with a hemostatic material which may enhance hemostasis by physical means. The device is intended to be removed once the patient is stabilized.
- (b) **Classification.** Class II (special controls). The special controls for this device are:
  - (1) Animal performance testing must demonstrate that the device performs as intended under anticipated conditions of use. Specifically testing must:
    - (i) Demonstrate that the device is able to achieve hemostasis;
    - (ii) Demonstrate that the device can be radiographically detected; and
    - (iii) **Assess pertinent safety endpoints including vascular obstruction and adhesion formation.**
  - (2) The device must be demonstrated to be biocompatible.
  - (3) Non-clinical performance data must demonstrate that the device performs as intended under anticipated conditions of use. The following tests must be performed:
    - (i) In vitro clot assessment;
    - (ii) Particulate release testing;
    - (iii) Physical characterization, including swelling percent and particulate size;
    - (iv) Chemical characterization;
    - (v) Radiopacity testing; and
    - (vi) **Mechanical integrity testing, including tensile strength and tear strength.**
  - (4) Performance data must demonstrate the sterility of the device.
  - (5) Performance data must support the shelf life of the device by demonstrating continued sterility, package integrity, and device functionality over the identified shelf life.
  - (6) Labeling must include the following:
    - (i) Instructions for use, including an instruction to remove all visible device components by irrigation;
    - (ii) The maximum amount of time the device may be left within the body;
    - (iii) A shelf life;
    - (iv) A contraindication for intravascular use of the device; and
    - (v) **A warning regarding the potential for adhesion formation.**

## Notes

### Amendments

[83 FR 6794, Feb. 15, 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 6794, Feb. 15, 2018]