FDA warns about unapproved tools for diagnosing head injuries

The Food and Drug Administration issued a warning on Wednesday that medical devices marketed for the diagnosis of a head injury that have not been reviewed by the agency might not be safe or effective.

The FDA’s safety communication expressed concerns about “potential serious risks which may be associated with the use of unapproved or uncleared medical devices for the diagnosis, treatment or management of a concussion,” including smartphone- or tablet-based apps marketed to parents or coaches for use during sporting events.

In its public warning, the agency said it has identified several medical device manufacturers marketing their tools to consumers for concussion diagnosis, treatment or management without the FDA approval or clearance.

“The use of unapproved medical devices may lead to an incorrect diagnosis,” states the FDA’s communication. “Additionally, the FDA has not approved or cleared any devices that can assess or diagnose a head injury, including suspected concussion and other traumatic brain injuries without an evaluation by a healthcare provider.”

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The agency emphasized that if any head injury, including concussion, is suspected by consumers, they should immediately seek medical treatment by a provider as “returning to normal activities could lead to worsening of the injury.”

“Products being marketed for the assessment, diagnosis or management of a head injury, including concussion, that have not been approved or cleared by the FDA are in violation of the law,” said Jeffrey Shuren, MD, director of the FDA’s Center for Devices and Radiological Health. “The FDA routinely monitors the medical device market and became aware of violative products being marketed to consumers.”

Shuren added that the agency has notified companies about the FDA’s concerns and has asked them to remove false or misleading claims. “We will continue to monitor the marketplace for devices making these unsubstantiated claims and are prepared to take further action if necessary,” he warned.