(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.

[80 FR 46486, Aug. 5, 2015]