FDA www.fda.gov does not develop medical devices for marketing, but the agency does review and evaluate medical devices. FDA has evaluated devices that might treat and diagnose Traumatic Brain Injury (TBI), FDA considers the safety and effectiveness of a product by evaluating the potential benefits and risks that the device poses.
Recently, the FDA approved the marketing of first-of-kind computerized cognitive tests to help assess cognitive skills after a head injury. The tests referred to as “Immediate Post-Concussion Assessment and Cognitive Testing” (ImPACT) plus “ImPACT Pediatric” are intended to assess cognitive function following a possible concussion.
FDA reviewed the devices through their de novo classification process, a regulatory pathway for novel low-to-moderate-risk medical devices that are first-of-a-kind where special controls can be developed. The device is manufactured by ImPACT Applications www.ImPACT.com located in Pittsburgh.
ImPACT software runs on a desktop or laptop and is intended for ages 12-59 while the ImPACT Pediatric runs on an iPad and is designed for children ages 5 to 11. It is required that only licensed healthcare professionals should perform the test analysis and interpret the results.
These new devices are not intended to diagnose concussions or determine appropriate treatments. The devices are meant to test cognitive skills such as word memory, reaction time and word recognition. The results are then compared to an age-matched control database or to a patient’s pre-injury baseline scores if available.