Smartphone-based eye exams, the province of a growing number of digital health startups, has caught the attention of the American Optometric Association, who penned a letter to the FDA yesterday asking that the agency impose stricter guidance on Opternative, a smartphone-based eye exam startup that raised $6 million earlier this year. Politico first spotted the news.
Opternative is registered with the FDA as a Class 1 device, which do not require pre-market approval. CEO Aaron Dallek told MobiHealthNews in February that the technology is robust and validated.
"We’ve done an independent clinical trial that’s proven that our technology is statistically equivalent [to an office visit] and our satisfaction is over 99 percent with the prescriptions that are dispensed from our service to date. So we are very confident that patients will get a prescription they’re satisifed with using our technology," Dallek said at the time.
The AOA isn't sold. In their 11-page missive, the organization argues that not only is the technology unproven, but it will lead patients to skip eye health exams and endanger their wellbeing.
"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," AOA President Steven Loomis wrote. "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. 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."
In the letter, Loomis breaks down each part of Opternative's test, based on information on the company's website and patent application, and outlines the areas where it differs from established practice. He then goes after their justification for eschewing 510(k) clearance in favor of Class 1 registration.
"[W]e presume that Opternative is marketing the device without FDA clearance or approval under the theory that its device falls within 510(k)-exempt classifications because, among other things, it uses one or more visual acuity charts to test a user’s vision and generate a lens prescription," he writes. "If this is Opternative’s theory, it is entirely flawed. The intended use of Opternative’s device and the technology it uses are far different from those of a visual acuity chart or any other legally marketed ophthalmic device. In addition, the device is intended to replace the judgment of an eye care professional in prescribing lenses and raises significant new questions of safety and effectiveness. Thus, the device cannot lawfully be marketed without prior review and clearance or approval by CDRH."
Loomis recommends that the FDA require Opternative to seek 510(k) or de novo clearance, and that Opternative halt sales until doing so. He notes that the Michigan Department of Licensing and Regulatory Affairs already issued Opternative a cease and desist last month.
"At this point, no 510(k) premarket notification has been cleared, no de novo request has been granted, and no PMA for the Opternative device has been approved," Loomis wrote. "Accordingly, the device is a Class III device that is adulterated and misbranded. It should be taken off the market until CDRH has studied the technology and use of the device, its safety and effectiveness, and the claims that are being made for the device in labeling. This action should be taken promptly."