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​FDA: Opternative in violation of federal law; AOA complaint validated

Thursday, March 15, 2018  

 FDA: Opternative in violation of federal law; AOA complaint validated

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 that confirmed AOA's original safety complaint.

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."

These concerns reflect the very points that AOA first broached in a 2016 complaint to the FDA regarding Opternative's lack of a premarket approval (PMA) prior to marketing, and lack of a formal FDA review of the product's safety and efficacy. As such, 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.

"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.'"

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