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# Traumatic Brain Injury Eye Assessor in Class 2
- URL: https://www.fdaweb.com/traumatic-brain-injury-eye-assessor-in-class-2/
- Published: 2021-12-16T12:00:00.000Z
- Updated: 2026-09-14T17:26:10.000Z
- Author: David McFarland
- Tags: FDA Policy/General, #legacy-id-D5150790

*Federal Register* notice: FDA is classifying the traumatic brain injury eye movement assessment aid into medical device Class 2 (special controls). The action is based on a de novo classification request by Oculogica for its EyeBox. The agency identified it as a prescription device that uses a patient’s tracked eye movements to provide an interpretation of the functional condition of a patient’s brain. The device is an assessment aid that is not intended for standalone detection or diagnostic purposes. To view the notice, click [here](https://www.govinfo.gov/content/pkg/FR-2021-12-16/pdf/2021-27227.pdf?ref=fdaweb.com).