FDA Warns Against use of Unapproved Medical Devices for Assessment or Diagnosis of Concussion

PUBLISHED: Apr 10, 2019
Relevant to: All Healthcare Organizations

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 has issued a new safety 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.

Certain products intended to aid in the assessment, diagnosis, or management of a head injury, which includes concussion, traumatic brain injury (TBI), and mild traumatic brain injury (mild TBI or mTBI) are considered medical devices regulated by the FDA. These include products 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 mental (cognitive) status including vision, concentration, memory, balance, and speech.

The FDA has identified several manufacturers that were marketing medical devices for concussion diagnosis, treatment, or management without the FDA’s approval or clearance. The use of unapproved medical devices may lead to an incorrect diagnosis. An incorrect diagnosis of “no head injury” after an injury, for example, could lead a person with a serious head injury to return to their normal activities instead of getting medical care. Not getting needed medical care and returning to normal activities could lead to worsening of the injury.

To date, there are a limited number of medical devices that have been approved or cleared by the FDA to aid in diagnosis, treatment, or management of head injury, including suspected concussion and other traumatic brain injuries. Additionally, the FDA has not approved or cleared any devices that can assess or diagnose a head injury, including suspected concussion and other traumatic brain injuries without an evaluation by a health care provider.

Recommendations for Health Care Providers:

  • Be aware that the safety and effectiveness of devices for diagnosis, assessment, or management of head injuries, such as concussion, have been established in only a limited number of devices, which should only be used by a health care provider.
  • Be aware that there are limitations that should be considered when using cleared and approved devices to aid in diagnosing, treating, or managing concussion, and labeling should be followed closely.
  • Discuss the benefits and risks of all available options for diagnosing and managing head injuries, including concussion, with your patient and their caregiver.
  • If any patients experience adverse effects from procedures that involved the use of a medical device intended to diagnose, treat or manage a brain injury, the FDA encourages you to file a report through MedWatch, the FDA Safety Information and Adverse Event Reporting program.

The Safety Communication also includes recommendations for individuals, parents and caregivers, athletic coaches and athletic administrators.

Want to read the full alert and receive alert emails?

Browse Additional Alerts