FDA Marketing of Concussion Evaluation Software

On August 22, 2016 FDA allowed marketing of first-of-kind computerized cognitive tests to help assess cognitive skills after a head injury. The FDA reviewed the ImPACT device through its de novo classification process, a regulatory pathway for novel, low- to-moderate-risk medical devices that are first-of-a-kind, for which special controls can be developed, in addition to general controls, to provide a reasonable assurance of safety and effectiveness of the devices. The device is manufactured by ImPACT Applications, located in Pittsburgh, Pennsylvania. The full FDA annoouncement is at the link provided.

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