The Food and Drug Administration (FDA) has advised online refraction company Opternative that its services constitute a medical device and, as such, require “marketing clearance,” according to a letter the agency issued in October, but didn’t publicize until March. The letter indicates that the company, which was sending marketing e-mails as of March 22, has been operating in violation of the Federal Food, Drug, and Cosmetic Act. In the letter, the FDA “requests that Opternative, Inc. immediately cease activities that result in the misbranding or adulteration of the On-Line Opternative Eye Examination Mobile Medical App device, such as the commercial distribution of the device through your online website.”

Opternative just hit a roadblock with an FDA warning letter.

“We responded promptly to FDA’s warning letter from October 2017, and we are working diligently to voluntarily comply with all regulatory requirements,” says a representative from Opternative. “We continue to communicate with the FDA on a regular basis to work through the regulatory medical device clearance process with our outside experts.”

The FDA’s letter also says that the agency determined that the app “is a device because it is intended for use in the diagnosis of disease or other conditions or in the cure, mitigation, treatment, or prevention of disease, or to affect the structure or any function of the body.” It also outlines how Opternative can submit for premarket approval and “whether the product may be legally marketed.”

The American Optometric Association (AOA) is counting the FDA’s action as “validation” of its 2016 complaint. “Despite the October 2017 FDA warning letter, Opternative has continued to market their device through 1-800 Contacts, etc. until the filing was made public,” says Clarke Newman, OD, AOA Federal Relations Committee chair.

“We recognize our technology and our new way of helping patients get their prescriptions renewed are viewed as disruptive to those who wish to prohibit emerging technologies from entering the vision prescription renewal space,” said an Opternative representative.

Although the AOA has historically opposed online refraction, a spokesperson underscores that the association supports technologies, so long as they don’t interrupt the patient-doctor relationship.

Food and Drug Administration. Inspections, Compliance, Enforcement, and Criminal Investigations. Opternative Inc 10/30/17  Warning Letter.