Federal regulations · Through 2026-08-25 · Newer source version available

21 CFR 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.

Where this section sits in the code

Title 21—Food and Drugs
CHAPTER I—FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES
SUBCHAPTER H—MEDICAL DEVICES
PART 878—GENERAL AND PLASTIC SURGERY DEVICES
Subpart E—Surgical Devices

(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.

Collected 2026-08-27T02:24:47Z. Source file · JSON

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