FDAnews Device Daily Bulletin
Medical Devices / Regulatory Affairs

FDA Issues Warning on Using Illicit Head Injury Diagnosis Devices

April 12, 2019
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The FDA recommended that consumers use only cleared or approved medical devices to assess or diagnose a head injury, including concussions.

The agency said it discovered several devicemakers marketing devices for diagnosing or assessing concussions—but their devices had not received FDA clearance or approval and could give a false diagnosis.

“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,” the agency said.

Only a “limited number” of devices have earned the agency’s clearance or approval to help manage or detect concussion.

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