FDA Alert on Using Only Approved Medical Devices to Help Assess or Diagnose a Head Injury, Including Concussion

The U.S. Food and Drug Administration (FDA) is concerned that products that do not have FDA clearance or approval are being marketed to individuals, including parents and caregivers, athletic coaches, and health care providers for the assessment, diagnosis, or management of a head injury, including concussion. The FDA is issuing this communication to make the public and health care providers aware of the potential serious risks which may be associated with the use of unapproved or uncleared medical devices for the diagnosis, treatment or management of a concussion. The FDA reminds individuals to seek treatment by a health care provider if any head injury, including concussion, is suspected.

Click here to view the alert regarding the use of non-FDA approved medical devices to assess head injury

FDA Alert














The FDA Center for Devices and Radiological Health (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.   Additional information is being provided by the FDA Center for Devices and Radiological Health (CDRH) on legally marketed medical devices. 

Click here to view FDA information on medical devices available in the United States that are legally marketed (Updated 4/10/19).