FDAnews Device Daily Bulletin
Medical Devices / Regulatory Affairs

FDA Issues Warning on Using Illicit Head Injury Diagnosis Devices

April 12, 2019

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.

View today's stories