Federal Food & Drug Administration Approval Of ImPACT De Novo Request For Classification

On August 22, 2016, the federal Food and Drug Administration sent this letter to ImPACT Applications, Inc. regarding its review of the de novo request for classification of the ImPACT and ImPACT Pediatric assessment devices. This order classifies the ImPACT and ImPACT Pediatric, and substantially equivalent devices of this generic type, into class II under the generic name, Computerized Cognitive Assessment Aid for Concussion . . .