In a statement, Jeffrey Shuren, M.D., J.D., director of the FDA’s Center for Devices and Radiological Health, said, “I want to be clear— there are currently no devices to aid in assessing concussion that should be used by consumers on their own.”
Additionally, Shuren said the sellers of products for the assessment, diagnoses or management of a head injury are violating the law. The FDA is regularly monitoring the medical device market and became aware of products for sale that are in violation of the law.
Furthermore, he said the department notified the companies selling these products and ordered the removal of their claims.
“We will continue to monitor the marketplace for devices making these unsubstantiated claims and are prepared to take further action if necessary,” said Shuren.
The FDA is advising consumers, caregivers, parents, and athletic coaches to immediately seek medical treatment for individuals, if they suspect a head injury including concussion happened.
