The US Food and Drug Administration (FDA) has told Opternative Inc to stop marketing its mobile eye examination app, saying the company has not applied for marketing clearance or approval of the medical device and is in violation of the Federal Food, Drug, and Cosmetic Act.
The FDA sent a warning letter to Chicago-based Opternative Inc on October 30, 2017, giving the company 15 days to respond in writing with specific steps it would take to comply with the FDA's requirements and how it would prevent similar violations in the future. The FDA just released the letter recently.
The On-Line Opternative Eye Examination Mobile Medical App allows adults aged 18 to 55 years who have previously undergone a full eye examination and received a prescription for corrective lenses to test their vision using a computer or tablet, according to information on the company's website. It is not intended for those with medical conditions that could affect vision, including diabetes. The service is currently available in 37 states.
The warning letter follows a June 15, 2016, meeting during which the FDA's Office of Compliance and the Office of Device Evaluation told the company of the need for a premarket submission, so the FDA could evaluate the safety and effectiveness of the device.
"Adulterated" and "Misbranded," FDA Says
"The Opternative device relies on unproven technology that has never, to our knowledge, been shown to be safe or effective in accurately determining a lens prescription. Specifically, the device relies on new, self-administered tests of visual performance to generate a prescription, rather than on assessment by an eye care professional of the underlying eye conditions affecting vision," the American Optometric Association wrote in a complaint filed with the FDA on April 4, 2016.
"There are many reasons to doubt the accuracy of prescriptions generated by this approach. Worse yet, use of the device will result in the forgoing of an examination by an eye doctor that is designed to detect a variety of conditions that could affect vision or general health and that require medical treatment," the American Optometric Association continued.
The FDA said the app qualifies as a device because it is used to diagnose disease or other conditions or to cure, mitigate, treat, or prevent disease or to have an impact on the structure of the body or any bodily function.
According to the FDA, the device is adulterated because the company does not have an approved application for premarket approval (PMA) or for an investigational device exemption. Further, the device is misbranded because the company failed to notify the FDA of its "intent to introduce the device into commercial distribution" as required, the FDA states in the warning letter.
"For a device requiring premarket approval, the notification required…is deemed satisfied when a PMA is pending before the agency," according to the warning letter.
FDA Instructions to Opternative
The FDA instructed the firm to submit the information listed on its website, after which it will evaluate the information and decide whether the device "may be legally marketed."
The FDA asked the company to stop any activities that lead to misbranding or adulteration of the device, such as using its website to commercially distribute the app.
"Your firm should take prompt action to correct the violations addressed in this letter. Failure to promptly correct these violations may result in regulatory action being initiated by the FDA without further notice. These actions include, but are not limited to, seizure, injunction, and civil money penalties," the FDA warned in the letter.
"Also, federal agencies may be advised of the issuance of Warning Letters about devices so that they may take this information into account when considering the award of contracts."
"We have responded to the Warning Letter and we are working closely with FDA on this matter," Pete Horkan, head of government affairs, Opternative Inc, told Medscape Medical News.
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Cite this: FDA Warns Opternative to Stop Marketing Eye Exam App - Medscape - Mar 15, 2018.