FDA: Opternative in Violation of Federal Law

FDA: Opternative in Violation of Federal Law

Tuesday, March 20, 2018

Opternative has marketed its app-based vision test without clearance or approval required by the government, in violation of federal law, the U.S. Food and Drug Administration (FDA) warned in an enforcement action.

Issued to the online vision test company on Oct. 30, 2017, but not made public until March 9, 2018, an FDA warning letter admonished that Opternative was in violation of the Federal Food, Drug and Cosmetic Act (FDCA), and requested the company "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."

American Optometric Association (AOA) President Christopher J. Quinn, O.D., applauds the FDA enforcement action and calls it a major victory for public health and safety. "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," Dr. Quinn says.

The AOA maintains that Americans risk their overall eye health when prioritizing convenience ahead of quality, in-person care.

The contents of this article are provided courtesy of the American Optometric Association.