In recent years, the Food and Drug Administration (FDA) has cleared various innovative devices to help assess, diagnose, or manage head injuries, including concussions, traumatic brain injuries (TBI), and mild traumatic brain injury (mild TBI or mTBI). Some of these products involve smartphone or tablet-based apps that determine an injured patient’s change in mental status using vision, concentration, memory, balance and speech.

Because these products are designed to assess, diagnose or treat a medical condition, they are considered medical devices and are regulated by the FDA, and thus must be approved by the FDA before they can be marketed.

However, the FDA is concerned that unapproved devices are being marketed to individuals including parents and caregivers, athletic coaches and health care providers. This poses potential serious risks, the FDA cautioned, since the device may convince these individuals that a person with a suspected head injury, including concussion, doesn’t need to be seen by a health care provider.

“The use of unapproved medical devices may lead to an incorrect diagnosis,” the FDA cautioned in a Safety Communication. “An incorrect diagnosis of ‘no head injury’ after an injury, for example, cold lead a person with a serious head injury to return to their normal activities instead of getting medical care … (which) could lead to worsening of the injury.”

The FDA’s Safety Communication was issued after the agency became aware that there were companies marketing medical devices to help diagnose or assess head injuries. The agency communicated its concerns to the companies.

The FDA said it will continue to actively monitor promotional materials, including materials on the internet and products for smartphones and tablets, and claims about uses of these and similar medical devices. The agency  will also continue to monitor complaints and adverse event reports from the public, health care providers, and industry.

Source: FDA Safety Communication

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