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FDA Issues Warning Letter to Opternative

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The firm’s app lacks the required approval.

The U.S. Food and Drug Administration has issued a warning letter to Opternative for marketing its eye exam mobile app “without marketing clearance or approval.”

The agency requested that 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.”

The letter was dated Oct. 30, 2017, and posted online last week.

The app is a device “because it is intended for use in the diagnosis of disease or other conditions or in the cure, mitigation, treatment, or prevention of disease, or to affect the structure or any function of the body,” according to the agency.

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The letter instructed Opternative to respond within 15 days explaining how it would correct the violations described in the letter. Failure to correct the alleged violations could result in actions such as seizure, injunction and assessment of civil monetary penalties, according to FDA.

Buzzfeed News quoted Opternative’s Peter Horkan saying, “We have responded to the Warning Letter and we are working closely with FDA on this matter.”

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