Though the U.S. Food and Drug Administration (FDA) has warned online vision test company Opternative to cease its activities because it didn’t get the necessary premarket approval, Opternative says it is continuing operation while working with the FDA on the issue.
The FDA’s warning letter was sent October 2017, requesting that Opternative “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.”
That letter was recently posted on the FDA’s website, which then generated a few news stories about it, prompting Opternative to respond with a statement. Opternative has responded to the FDA letter, it said, and continues to communicate with the FDA on a regular basis to work through the regulatory medical device clearance process.
To read the full warning from the FDA to Opternative, click here
In its statement, Opternative said: “Opternative has been working closely with the FDA since the first days of our company and we are continuing to work closely with the agency. We responded promptly to FDA's warning letter from October 2017 and we are working diligently to voluntarily comply with all regulatory requirements. We share the FDA's commitment to protecting patients and helping consumers access safe and reliable health services. As our company and technology has evolved and improved, we have worked diligently with the FDA to keep them up to date on all the ways we are working to help consumers every day.”
The warning letter was heralded as a victory by the American Optometric Association (AOA), which says it reflects the very points that it first broached in a 2016 complaint to the FDA regarding Opternative's lack of a premarket approval prior to marketing, and lack of a formal FDA review of the product's safety and efficacy. The AOA has been very vocal in its opposition to Opternative. To read a synopsis of the AOA’s complaints about Opternative, click here.
According to a news story on FierceBiotech.com, the Opternative/FDA 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."