The FDA has sent a warning letter telling Opternative to stop distributing its mobile eye examination app. Regulatory officials view the online vision test app as a device and as such want Opternative to file for premarket approval.
Opternative provides an online vision test that enables people to get prescriptions for contact lenses and glasses using their smartphone and computer. Users stand 10 feet away from their screens and complete a 15-minute assessment of their sight. The results go to a state-licensed ophthalmologist who writes and signs a digital prescription that is valid anywhere.
The model has put Opternative at loggerheads with the optometric establishment. In April 2016, the American Optometric Association (AOA) alerted (PDF) the FDA to Opternative. As the AOA sees things, the startup “poses significant health risks” because it uses “unproven technology” that has never been assessed by the FDA.
Two months after receiving the letter, the FDA met with Opternative and told it to file a premarket submission to enable the evaluation of its safety and efficacy. More than a year later, the FDA sent a warning letter to Opternative.
The warning letter, which FDA sent in October but only made public recently, states Opternative’s app is classed as a device under U.S. regulations. And, as such, Opternative’s decision not to seek premarket approval or notify the FDA of its entry into commercial distribution renders it adulterated and misbranded in the eyes of the agency.
Officials told Opternative to “immediately cease” commercial distribution of the app in the October warning letter. Five months later, the service remains online. Opternative told Medscape Medical News it has responded to the warning letter and is working with the FDA to resolve the situation.
The case has parallels with the FDA’s interactions with 23andMe, which brought consumer-targeted genetic tests to market without getting clearance from the agency and then responded tardily when regulators scrutinized its operation. 23andMe eventually resolved the standoff but only after revising its approach to regulatory interactions.