Home News Opternative's Response to FDA Request

Opternative’s Response to FDA Request

Here's a press release that Opternative released last week

Opternative released this press release March 21, 2018, noting that it had already responded to the six-month old FDA warning letter that became public just recently.

Opternative, Onward: Company Releases Statement on FDA Approval Process.

Glasses and contact lens wearers rely on Opternative every day to help get their prescriptions renewed. 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.

Each year, less than 50 percent of the U.S. adult population get vision screenings of eye exams due to barriers to access like time, cost and inconvenience. Over 50 million adults have not had an exam in the past 2 years, and many millions have never had an eye exam, which can lead to trouble reading, driving, and other important activities of daily living. Opternative started based on the premise that consumers need increased access to vision exams. Increasing the frequency of vision tests to complement an eye health exam is what consumers want and need. Remote vision tests are a key component towards solving that need. We have already helped increase access and service to hundreds of thousands of patients through our platform.

We look forward to continuing our work with all eye-care professionals to increase access to high quality, patient-centered eye care as we continue to offer our physician-reviewed, prescription renewal technology to healthy consumers. We recognize our technology and our new way of helping patients get their prescription renewed are viewed as disruptive to those who wish to prohibit emerging technologies from entering the vision prescription renewal space.

Last week’s news stories are based on a six-month-old FDA Warning Letter. As noted above, we responded to the FDA’s letter in a timely manner. We continue to communicate with the FDA on a regular basis, to work through the regulatory medical device clearance process with our outside experts. Our state of the art service provides patients with more convenient, more accessible eye-care services and prescription renewals online.

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