FDA Warns Against Use of Unapproved Medical Devices to Help Assess or Diagnose a Concussion

Officials with the FDA are 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 today's safety communication, the FDA warned that such tools, including mobile apps marketed to coaches or parents for use during sporting events, have not been reviewed by the agency for safety and efficacy and could result in an incorrect diagnosis. An incorrect diagnosis could potentially lead to a person with a serious head injury to return to their normal activities instead of seeking 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.

“I want to be clear, there are currently no devices to aid in assessing concussion that should be used by consumers on their own,” said Jeffrey Shuren, MD, JD, director of the FDA’s Center for Devices and Radiological Health, in a prepared statement. “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.

According to Shuren, the FDA routinely monitors the medical device market. The agency has alerted companies to 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,” said Shuren.

In the safety communication, FDA officials explained 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 cognitive status, including vision, concentration, memory, balance and speech.

The FDA’s recommendations for consumers, parents, caregivers and athletic coaches note that individuals should seek treatment right away from a health care professional if any head injury, including concussion, is suspected.

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Reference

FDA warns public not to use unapproved or uncleared medical devices to help assess or diagnose a concussion [news release]. Silver Spring, MD; April 10, 2019: FDA website.https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm635720.htm. Accessed April 10, 2019.