Concussion Assessments: FDA Warns Against Using Unapproved Devices

Regulatory NewsRegulatory News | 10 April 2019 |  By 

The US Food and Drug Administration (FDA) on Wednesday warned against using a smartphone- or tablet-based app to assess whether an injured or possibly concussed person is suffering from a change in physical or mental status including vision, concentration, memory, balance and speech.

After identifying several manufacturers marketing devices for concussion diagnosis, treatment or management without FDA’s approval or clearance, the agency said it issued a safety communication to make the public and health care providers aware of the potential serious risks which may be associated with the use of such unapproved or uncleared devices.

“FDA reminds individuals to seek treatment by a health care provider if any head injury, including concussion, is suspected,” the agency said. “An incorrect diagnosis of ‘no head injury’ after an injury, for example, could lead a person with a serious head injury to return to their normal activities instead of getting medical care. Not getting needed medical care and returning to normal activities could lead to worsening of the injury.”

The agency also compiled a list of 13 devices that are legally marketed in the US for assessing head injury.

Jeffrey Shuren, director of FDA’s Center for Devices and Radiological Health, added: “I want to be clear, there are currently no devices to aid in assessing concussion that should be used by consumers on their own...FDA has alerted companies to our concerns and asked them to remove such claims. We will continue to monitor the marketplace for devices making these unsubstantiated claims and are prepared to take further action if necessary.”

Safety Communication


© 2023 Regulatory Affairs Professionals Society.

Discover more of what matters to you

No taxonomy