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FDA Issues Concerns Over Unapproved Medical Devices For Head Injuries


The U.S. Food and Drug Administration (FDA) issued safety communications on April 10th, 2019, detailing its concerns over unapproved medical devices intended to treat, manage or diagnose head injuries.

The FDA identified several unapproved medical devices with no FDA clearance on the market which were being sold for the diagnosis, treatment or management of concussions and other head injuries. The FDA specifically singled out the danger of unapproved medical devices leading to incorrect “no head injury” diagnoses, which could later lead to the head injury getting worse. The FDA also stressed that there are zero approved medical devices on the market which can accurately diagnose a head injury without a doctor’s evaluation. There are very few devices approved by the FDA for the management, treatment or diagnosis of head injuries.

The FDA singled out the example of products which have their users take tests on a tablet or smart phone; these products claim to be able to diagnose head injuries based on the results of these tests. These tests can ask questions relating to focus, eyesight, memory, speech and balance. The FDA notes these apps are marketed towards parents and coaches who are involved in sports.

There are many ways to obtain a head injury, from tripping and falling to getting in a car accident. The FDA’s safety communications recommend that patients, doctors, parents and caregivers of people with suspected head injuries, coaches and administrators in sports and doctors and trainers in sports only utilize approved medical devices for the management, treatment or diagnosis of head injuries. The safety communications also recommend that anyone who suspects they have a head injury go to the doctor for medical treatment.

The FDA recommends that those who have experienced problems after treating others with or being treated with a medical device for head injuries contact Medwatch.

The FDA said that it has contacted manufacturers of unapproved medical devices and asked them to rescind claims that their products can diagnose, treat or manage head injuries. The FDA also announced that they would continue to monitor the marketplace for unapproved medical devices intended to treat, manage or diagnose head injuries, and said that if its concerns about these devices are not dealt with, they will then need to determine if additional action, including enforcement, is needed.

The FDA recommends that medical devices being marketed for purposes which are not FDA approved be reported via the FDA’s Reporting Allegations of Regulatory Misconduct protocol, and that people contact their local FDA Consumer Complaint Coordinator to help them with the reporting process.

The law firm of Nadrich & Cohen has represented many accident and injury victims with serious head injuries. We understand how important it is for patients to get a prompt and accurate diagnosis. Lead partner, Jeff Nadrich, notes that the recent FDA recommendation is an important step towards making sure that head injury and brain injury patients obtain the most accurate diagnosis for their condition in order to facilitate proper and effective treatment.”


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