The FDA today warned consumers against using medical devices purported to assess head injuries, saying tht only five companies are cleared to market such devices in the U.S. and that they should only be used by physicians.
“The FDA has identified several manufacturers that were marketing medical devices for concussion diagnosis, treatment or management without the FDA’s approval or clearance,” the federal safety watchdog said. “To date, there are a limited number of medical devices that have been approved or cleared by the FDA to aid in diagnosis, treatment or management of head injury, including suspected concussion and other traumatic brain injuries. 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 health care provider.”
“I want to be clear, there are currently no devices to aid in assessing concussion that should be used by consumers on their own. Using such devices can result in an incorrect diagnosis after a head injury that could lead a person with a serious injury to return to their normal activities instead of seeking critical medical care, putting them at greater danger,” added Center for Devices & Radiological Health director Dr. Jeffrey Shuren. “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. The FDA routinely monitors the medical device market and became aware of violative products being marketed to consumers. The 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.”