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# Brain Trauma Assessment Tests are Class 2
- URL: https://www.fdaweb.com/brain-trauma-assessment-tests-are-class-2/
- Published: 2018-06-14T12:00:00.000Z
- Updated: 2026-09-15T00:13:18.000Z
- Author: David McFarland
- Tags: FDA Policy/General, #legacy-id-D5141685

*Federal Register* notice: FDA has classified brain trauma assessment tests into Class 2 (special controls). The devices are identified as those comprising reagents used to detect and measure brain injury biomarkers in human specimens. The measurements aid in the evaluation of patients with suspected mild traumatic brain injury in conjunction with other clinical information to assist in determining the need for head imaging per current standard of care. To view the notice, click [here](https://www.gpo.gov/fdsys/pkg/FR-2018-06-14/pdf/2018-12760.pdf?ref=fdaweb.com).