In this situation, the reviewer of the 510(k) submission will bring the attention to the senior division management, who will then consider:
- Whether there is a reasonable likelihood that the device will be used for an intended use not identified in the proposed labeling for the device, and
- If such use could cause harm to the patient or the consumer.
If they determine that one of these statements are true, then the reviewer will proceed to discuss all deficiencies with regard to the submission and have them resolved. When all outstanding issues have been resolved, the reviewer will then bring up the concern of the label discrepancy. There will be additional regulations and limitations for legally marketed devices that have deficiencies regarding off-label use.
In the case that the Office Director believes that there is a reasonable likelihood that the device will be issued for an intended use not identified in the proposed labeling and could cause harm, there are two pathways, wherein the firm can either modify the device design to address the off-label use, or request a written determination from the Office Director. If the firm fails to address the concerns, then the Office Director will issue an “SE with limitations” letter within 10 days of the consultation.