FDA Takes Action on Bogus Claims for DIY Concussion Devices

Megan Brooks

April 10, 2019

In a safety communication issued today, the US Food and Drug Administration (FDA) warned that unapproved medical devices and tools that claim to help assess, diagnose, or manage concussion are being marketed to the public.

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

"Using such devices can result in an incorrect diagnosis after a head injury that could lead a person with a serious injury to return to their normal activities instead of seeking critical medical care, putting them at greater danger," said Shuren.

A limited number of medical devices have been cleared by the FDA to aid in the diagnosis, treatment, or management of concussion; all of them require an evaluation by a healthcare professional. The approved devices are listed on the FDA website.

The FDA became aware of unapproved medical devices being marketed to the public for concussion through routine monitoring of the medical device market.

The products of concern include those that claim to assess and diagnose any changes in brain function by having an injured person perform tests using a smartphone or tablet-based app to determine a change in physical or cognitive status, including changes in vision, concentration, memory, balance, and speech, the FDA said.

"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," said Shuren.

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