FDA warns against use of unapproved medical devices to diagnose head injury

The U.S. Food and Drug Administration has issued a warning to the public not to use medical devices marketed to consumers that claim to help assess, diagnose or manage the head injury, including concussion, traumatic brain injury (TBI) or mild TBI.

FDA has warned that such tools — such as apps on a smartphone marketed to coaches or parents for use during sporting events — have not been reviewed by the FDA for safety and efficacy and could result in an incorrect diagnosis, potentially leading to a person with a serious head injury returning to their normal activities instead of getting medical care.

To date, there are a limited number of medical devices that have been cleared or approved by the FDA to aid in the diagnosis, treatment, or management of concussion, and all of them require an evaluation by a health care professional.

“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,” said Jeffrey Shuren, M.D., J.D., director of the FDA’s Center for Devices and Radiological Health. “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.”

In the safety communication issued today, the FDA explains that the products of concern include those that claim to assess and diagnose any changes in brain function by having an injured person perform tests on a smartphone or tablet-based app to determine a change in physical or mental (cognitive) status including vision, concentration, memory, balance and speech.

The FDA’s recommendations for consumers, parents, caregivers and athletic coaches note that individuals should seek treatment right away from a health care professional if any head injury, including concussion, is suspected.

The FDA will continue to monitor promotional materials and claims about uses of these and similar products and contact companies when we see violative practices. If the agency’s concerns are not addressed, the FDA will consider what additional actions, including potential enforcement actions, are appropriate. The FDA will continue to monitor complaints and adverse event reports from patients, caregivers, health care providers and industry.