The Food and Drug Administration (FDA) has issued a warning regarding tools being marketed for assessing, diagnosing, or managing concussion that are not FDA-approved. The FDA notes that use of these tools, apps, and devices, may inaccurately lead injured individuals to believe they have been medically assessed and lead to false positive or false negative diagnoses. A false negative result for concussion is of particular concern as it could put individuals at risk of further brain injury.
This includes products that claim to assess changes in brain function by having an injured person perform tests on a smartphone- or tablet-based app that evaluates vision, concentration, memory, balance, and speech.
A limited number of medical devices have been cleared or approved by the FDA to aid in the diagnosis or treatment of concussion, and all require an evaluation by a healthcare professional.
“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, JD, director of the FDA Center for Devices and Radiological Health. “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.”
Devices for the Assessment of Head Injury
CDRH recognizes that head injury is a major source of concern since the presence and severity of a head injury may not be readily assessable. CDRH is committed to working with device researchers and developers to bring safe and effective devices to patients in the US that facilitate the assessment of head injury. The following table highlights medical devices available in the United States that are legally marketed. For more specific descriptions of these devices, their indications for use, and related information, please follow the links to the Premarket Databases shown.