FDA Gives De Novo Classification for Concussion Assessment Device

Under a de novo request for classification, the FDA has determined that ImPACT’s concussion devices are substantially equivalent and will be classified as Class II devices under “computerized cognitive assessment aid for concussion.”

The ImPACT is a neurocognitive test battery that measures neurocognitive functioning for managing concussions. The ImPACT pediatric provides similar measurements in children ages 5 to 11. — Tamra Sami