Today, the U.S. Food and Drug Administration is 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 a new safety communication, the FDA warned that such tools — such as apps on a smartphone marketed to coaches or parents for use during sporting events — have not been reviewed by the FDA for safety and efficacy and could result in an incorrect diagnosis, potentially leading to a person with a serious head injury returning to their normal activities instead of getting 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. 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 Jeffrey Shuren, M.D., J.D., director of the FDA’s Center for Devices and Radiological Health.
The FDA Safety Communication:
- Purpose: The U.S. Food and Drug Administration (FDA) is concerned that products that do not have FDA clearance or approval are being marketed to individuals, including parents and caregivers, athletic coaches, and health care providers for the assessment, diagnosis, or management of a head injury, including concussion. The FDA is issuing this communication to make the public and health care providers aware of the potential serious risks which may be associated with the use of unapproved or uncleared medical devices for the diagnosis, treatment or management of a concussion. The FDA reminds individuals to seek treatment by a health care provider if any head injury, including concussion, is suspected.
- Summary of Problem and Scope: The FDA has identified several manufacturers that were marketing medical devices for concussion diagnosis, treatment, or management without the FDA’s approval or clearance. 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. Not getting needed medical care and returning to normal activities could lead to worsening of the injury. To date, there are a limited number of medical devices that have been approved or cleared by the FDA to aid in diagnosis, treatment, or management of head injury, including suspected concussion and other traumatic brain injuries. Additionally, the FDA has not approved or cleared any devices that can assess or diagnose a head injury, including suspected concussion and other traumatic brain injuries without an evaluation by a health care provider.
News in Context:
- Study: Concussion diagnoses among children and teenagers increased by 71% from 2010 through 2015
- The FDA clears two computerized cognitive tests to assist in medical evaluations following brain injury or concussion
- Pear Therapeutics raises $50M to develop and market a portfolio of digital therapeutics for mental health