April 23, 2019
2 min read

FDA warns consumers against use of devices for assessing head injury

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The FDA warned the public not to use medical devices marketed to consumers that claim to help assess, diagnose or manage head injury.

An April 10 statement from the FDA said that tools such as smartphone- or tablet-based apps that may be marketed to coaches or parents have not been reviewed by the FDA for safety and efficacy, could result in an incorrect diagnosis and could potentially lead to someone with a concussion, traumatic brain injury (TBI) or mild TBI returning to normal activities instead of getting medical care.

A list of legally marketed medical devices designed for this purpose can be found here. However, these devices require evaluation by a health care professional.

“There are currently no devices to aid in assessing concussion that should be used by consumers on their own,” Jeffrey Shuren, MD, JD, director of the FDA’s Center for Devices and Radiological Health, said in the announcement. “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.”

Products of concern to the FDA include those that claim to assess and diagnose any changes in brain function by having an injured person perform app-based tests to determine a change in physical or cognitive status, including vision, concentration, memory, balance and speech.

“The Neuro-Optometric Rehabilitation Association (NORA) urges consumers to follow the FDA’s warning not to use unapproved or uncleared medical devices to help assess or diagnose a concussion on their own,” Charles Shidlofsky, OD, FCOVD, NORA secretary/treasurer, said in a statement provided to Primary Care Optometry News.

Charles Shidlofsky

Visual problems are often overlooked during initial treatment of a brain injury, he said, and in some cases symptoms may not be present until some time after the injury.

“We strongly urge consumers who may notice any changes in their vision following a concussion or some other head trauma not to ignore them and immediately contact their eye care professional to determine the cause of the vision change,” Shidlofsky said.

Studies show that at least 50% of TBI patients suffer from visual dysfunctions, with one such study finding a 90% incidence of post-trauma visual complications, such as blurred vision, sensitivity to light, reading difficulty, headaches with visual tasks and difficulties with eye movements (Ciuffreda et al.).

A NORA specialist can determine the presence of brain injury-related ocular changes, visual dysfunctions and visual processing deficits and provide medical or functional optometric rehabilitation services, Shidlofsky said.

He also noted that an integrated team approach, involving specialists such as neurologists, rehab physicians, nurses, physical and occupational therapists, speech-language pathologists, neuropsychologists and audiologists, may be necessary to address all of a patient’s needs. – by Nancy Hemphill, ELS, FAAO


Ciuffreda KJ, et al. Optometry. 2007;doi:10.1016/j.optm.2006.11.011