On the heels of approving two devices that help evaluate brain function after an injury or suspected concussion, the FDA has placed all similar devices into Class II and listed required steps to limit misevaluations.

In August, the FDA granted approval to Impact Applications’ Immediate Post-Concussion Assessment and Cognitive Testing (ImPACT) device and ImPACT Pediatric. These were the first devices the FDA indicated for cognitive testing after a brain injury.

An FDA final order terms all devices similar to ImPACT and ImPACT Pediatric “computerized cognitive assessment aids for concussion” and requires special controls to mitigate risks of false positives. These controls include clinical performance testing; software verification, validation, and hazard analysis; and specific labeling. — Jeff Kinney