Diagnosis

The U.S. Food and Drug Administration is warning the public not to use medical devices marketed to consumers that claim to help assess, diagnose or manage head injury, including concussion, traumatic brain injury (TBI) or mild TBI. In a new safety communication; the FDA warned that such tools; such as apps on a smartphone marketed to coaches; or parents for use during sporting events; have not 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.

No devices to aid in assessing concussion

“I want to be clear, there are currently no devices to aid in assessing concussion that should be used by consumers on their own. So, 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.“Products being; marketed for the assessment, diagnosis, or management of a head injury; including concussion, that have no approval; or cleared by the FDA are in violation; of the law. However, the FDA routinely monitors the medical device market and became aware of violative products; marketed to consumers. So the FDA has alerted companies to our concerns and asked them to remove such claims.

So, in the safety communication issued, 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 status including vision, concentration, memory, balance and speech.”I want to be clear, there are currently no devices to aid in assessing concussion that should be used by consumers on their own,” Jeffrey Shuren.”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.”

To monitor the marketplace for devices making

However, the FDA is concerned about products that claim to assess and diagnose changes in brain function by having a person who has suffered a head injury do tests on a smartphone or tablet-based app to detect changes in physical or mental function, including vision, concentration, memory, balance, and speech. Some of those apps are marketed to coaches and parents for use during sporting events. “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,” Shuren said in conclusion. “The FDA has alerted companies to our concerns and asked them to remove such claims. So, we will continue to monitor the marketplace for devices making these unsubstantiated claims and are prepared to take further action if necessary.”