Upon identifying several manufacturers marketing medical devices for concussion diagnosis, treatment, or management without their approval or clearance, the FDA has issued a statement to make the public and healthcare professionals (HCPs) aware of the potential serious risk that may be associated with their use. The agency reminds HCPs that only a limited number of devices have established safety and effectiveness and should only be used by HCPs.
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. “Products being marketed for the assessment, diagnosis, or management of a head injury, including concussion, that have not been approved or cleared by the FDA are in violation of the law. The FDA routinely monitors the medical device market and became aware of violative products being marketed to consumers. 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.”
In the safety communication issued today, the FDA explains that the products of concern include those that claim to assess and diagnose any changes in brain function by having an injured person perform tests on a smartphone or tablet-based app to determine a change in physical or mental (cognitive) status including vision, concentration, memory, balance and speech.
The FDA’s recommendations for consumers, parents, caregivers and athletic coaches note that individuals should seek treatment right away from a health care professional if any head injury, including concussion, is suspected.
The FDA will continue to monitor promotional materials and claims about uses of these and similar products and companies when we see violative practices. If the agency’s concerns are not addressed, the FDA will consider what additional actions, including potential enforcement actions, are appropriate. The FDA will continue to monitor complaints and adverse event reports from patients, caregivers, health care providers and industry.
The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.