---
kind: "section"
citation: "21 C.F.R. § 878.4670"
title: "21"
number: "878.4670"
heading: "Internal tissue marker."
url: "https://uscodex.org/cfr/21/878.4670"
---

# §878.4670. Internal tissue marker.

- (a) **Identification.** An internal tissue marker is a prescription use device that is intended for use prior to or during general surgical procedures to demarcate selected sites on internal tissues.
- (b) **Classification.** Class II (special controls). The special controls for this device are:
  - (1) The device must be demonstrated to be biocompatible. Material names and specific designation numbers must be provided.
  - (2) Performance testing must demonstrate that the device performs as intended to mark the tissue for which it is indicated.
  - (3) Performance data must demonstrate the sterility of the device.
  - (4) Performance data must support the shelf life of the device by demonstrating sterility, package integrity, device functionality, and material stability over the requested shelf life.
  - (5) Labeling must include:
    - (i) A warning that the device must not be used on a non-sterile surface prior to use internally.
    - (ii) **An expiration date/shelf life.**
    - (iii) Single use only labeling must be labeled directly on the device.

## Notes

### Amendments

[80 FR 46486, Aug. 5, 2015]

### 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

[80 FR 46486, Aug. 5, 2015]