This article is more than 5 years old. Information may no longer be current.
FDA posts warning letter to Opternative
Click Here to Manage Email Alerts
The FDA issued a warning letter to Opternative CEO Aaron Dallek regarding the company’s online eye examination mobile app.
The letter, dated Oct. 30, 2017, and posted on FDA.gov on March 9, 2018, states that Opternative is marketing the On-Line Opternative Eye Examination Mobile Medical App device in the U.S. without marketing clearance or approval, in violation of the Federal Food, Drug and Cosmetic Act.
The FDA considers this product a device, “because it is intended for use in the diagnosis of disease or other condition or in the cure, mitigation, treatment or prevention of disease, or to affect the structure or any function of the body,” according to the letter.
The FDA has determined that the app, “is adulterated ... because you do not have an approved application for premarket approval (PMA) in effect ... or an approved application for an investigational device exemption (IDE).”
The letter also states that the app is misbranded, as the company did not notify the FDA of its intent to introduce the device into commercial distribution.
The device requires a premarket submission to allow the FDA to evaluate its safety and effectiveness, which was outlined in a June 15, 2016, meeting at the FDA, according to the letter.
The FDA will evaluate the information submitted and decide whether the product may be legally marketed.
The agency requested that Opternative immediately cease activities that result in the misbranding or adulteration of its app, such as the commercial distribution of the device through its online website.
"We have responded to the warning letter and we are working closely with the FDA on this matter," Opternative’s Pete Horkan said in a statement provided to Primary Care Optometry News.
“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,” according to a statement from American Optometric Association President Christopher Quinn, OD.
“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,” he said. “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 AOA outlined potentially serious health risks for the agency and documented Opternative’s noncompliance with federal medical device and patient safety laws in a detailed complaint in 2016, according to the AOA statement.
“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,” Quinn said.