Months after clearing the first computer-based test intended to measure cognitive function after a suspected concussion, the US Food and Drug Administration (FDA) on Monday said it considers such devices to be Class II, or moderate risk devices.
In August, FDA cleared ImPACT Applications' Immediate Post-Concussion Assessment and Cognitive Testing (ImPACT) and ImPACT Pediatric devices via its de novo classification pathway, as no similar devices had been previously cleared by the agency.
The computerized concussion tool is currently used by more than 7,400 high schools, 1,000 colleges and universities, 900 clinical centers, 475 consultants, 200 professional teams and military units. The price of annual subscription packages to the program range from $400 to $1200 per school or organization.
Under federal regulations, new medical devices require pre-market approval by FDA unless the device is classified into Class I (general controls) or Class II (special controls) or if the device is found to be substantially equivalent to an already-marketed device that would not require premarket approval.
However, under the de novo classification pathway, sponsors of innovative devices for which there are no already-marketed devices to refer to for a determination of substantial equivalence can request FDA to classify their device.
Now, according to a final order issued by FDA on Monday, the agency says it will consider the ImPACT test, and other devices that fall under the newly established category "computerized cognitive assessment aid for concussion," to fall under Class II.
"After a review of the information submitted in the request, FDA determined that the device can be classified into Class II with the establishment of special controls. FDA believes these special controls, in addition to general controls, will provide reasonable assurance of the safety and effectiveness of the device," FDA says.
According to FDA, special controls are needed to mitigate the risk that the device could give false positive or false negative results of cognitive impairment resulting from a concussion. As such, the agency says it will require mitigating measures in the form of clinical performance testing; software verification, validation, and hazard analysis; and labeling measures which include several information requirements and warnings.
Some of the labeling measures include providing a summary of the clinical testing done to validate the device, and warnings that the device should only be used by healthcare professionals trained in concussion management, that the device does not identify the presence or absence of concussion and that the device is not a stand-alone diagnostic.
Going forward, FDA says that other devices that fall into the same category will be considered Class II, and will need to comply with the same special controls.