Opternative, a Chicago-based purveyor of online and mobile refractive eye exams, received a warning letter from the FDA last fall. The October 30 warning letter was only recently made public by the agency.
Addressed to then-CEO Aaron Dallek (Opternative named a new CEO, Brent Rasmussen, in January), the letter makes it clear that it considers Opternative's online eye exam to be a mobile medical app that requires premarket clearance. At present, Opternative's product is FDA-registered as a Class 1 device, but not cleared, an option for some low-risk devices.
"The United States Food and Drug Administration (FDA) has learned that your firm is marketing the On-Line Opternative Eye Examination Mobile Medical App device in the United States without marketing clearance or approval, in violation of the Federal Food, Drug, and Cosmetic Act (the Act)," the letter, signed by Cpt. Sean Boyd, deputy director for regulatory affairs at the agency's Office of Compliance, reads. "Under section 201(h) of the Act, 21 U.S.C. § 321(h), this product 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."
According to Opternative, the company has been in the process of responding to the letter since it was received six months ago.
"We have responded to the Warning Letter and we are working closely with FDA on this matter," the company said in an emailed statement to MobiHealthNews.
Like most online eye exam companies, Opternative is careful to emphasize that it provides only a refractive eye exam, not the comprhensive examination users would receive at an eye doctor. This is an important distinction, since Opternative's exam does not screen for conditions like cataracts or glaucoma. It's likely this is why the company didn't originally consider its product a Class 2 medical device. However, the Federal Food, Drug, and Cosmetics Act cited in the letter defines a medical device as one that is "intended for use in the diagnosis of disease or other conditions." Furthermore, the letter says Opternative was informed of the need for a premarket submission at a June 2016 meeting.
The letter instructs Opternative to "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."
The American Optometric Association, which has long been a vocal opponent of Opternative and other tele-eye exam services, weighed in on the news of the letter's release.
"The FDA's enforcement action against Opternative is major victory for public health and for the tens of millions of Americans who need and deserve access to quality care to safeguard their health and vision," AOA President Christopher Quinn wrote in a statement. "The AOA and our member doctors across the country are gratified that the FDA has taken such decisive action to address the urgent health and safety violations we identified, reported and relentlessly followed-up on. It is our hope that we are a step closer to holding all companies that would place profits ahead of patient care fully accountable for their actions."
The timeline of the June meeting, combined with the AOA's open letter to the FDA the prior April suggests that the Association may have prompted, or played a role in prompting, the agency response.
"As a consistent advocate in ensuring that patients have access to medically-recognized eye health care and to protect patients from companies, platforms or services that may put their health at risk, the AOA filed a detailed complaint in 2016 exposing Opternative's 'vision test'," Quinn continued. "The AOA outlined for the agency potentially serious health risks and documented the company's non-compliance with Federal medical device and patient safety laws. The AOA also described a persistent effort by online vision tests to evade federal oversight and regulation, as well as continued, deceptive marketing tactics that mislead patients and potentially jeopardize their eye and vision health."
Opternative has run into a number of roadblocks along the way for its telemedicine service, including having it banned in two states, South Carolina and New Mexico. In both cases, the governor vetoed the law, but in South Carolina the veto was overturned. Opternative sued South Carolina but the case was dismissed. The company is in the process of appealing the ruling.
The company has been public about its belief that its technology is safe and welcomed by patients, despite the AOA's insistence to the contrary.
"Optometrists are trying to ban ophthalmologists from issuing prescriptions for glasses and contact lenses via telemedicine tools," the company writes in public statement on its website. "New clinically proven technologies like Opternative would be blocked from providing patients access to safe, convenient, and low cost prescriptions for glasses and contacts. We believe that legislation should enhance, not diminish, consumers’ access to telehealth by: maximizing the types of technology that can be used; empowering providers to use the technology of their choice with patients; requiring secure use of information technology; eliminating barriers such as requiring prior in-person visits; [and] recognizing that telehealth is a tool, not a separate practice of medicine. Our 99.6 percent satisfaction rating is a testament to how much our patients love the Opternative experience."
MobiHealthNews has reached out to Opternative for additional comments and will update this story if they respond.