The American Optometric Association (AOA) doesn’t like smartphone-based eye exams, especially if they are not proven to work as good as a regular visit to an ophthalmologist. So they penned an 11-page letter (PDF) to the FDA asking that the agency impose stricter guidance on Opternative, which is registered with the FDA as a Class 1 device. As such, it does not require pre-market approval.
The AOA argues that Opternative could lead patients to skip eye health exams and endanger their well-being.
AOA recommends that the FDA require Opternative to seek 510(k) or de novo clearance, and consequently halt sales until doing so.“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 outlines the areas where it differs from established practice, and then goes after their justification for eschewing 510(k) clearance in favor of Class 1 registration.
“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,” he writes. “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 consequently halt sales until doing so. He adds that the Michigan Department of Licensing and Regulatory Affairs already issued Opternative a cease and desist last month.
“It [Opternative] 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,” Loomis concludes.