03.16.18

FDA Warns Opternative to Stop Marketing Eye Exam App

Source: Eyewiretoday.com
The FDA has sent a letter to Opternative warning the company to stop marketing the On-Line Opternative Eye Examination Mobile Medical App device. The letter states that the device has not received marketing clearance or approval in the United States, in violation of the Federal Food, Drug, and Cosmetic Act (the Act).
 
The On-Line Opternative Eye Examination Mobile Medical App allows adults aged 18 to 55 years who have previously undergone a full eye examination and received a prescription for corrective lenses to test their vision using a computer or tablet, according to Opternative.
 
On June 15, 2016, during a meeting held at the FDA, Opternative was notified by the Office of Compliance and the Office of Device Evaluation that the On-Line Opternative Eye Examination Mobile Medical App device requires a premarket submission in order to allow the Agency to evaluate its safety and effectiveness.
 
"FDA has reviewed your website and determined that the On-Line Opternative Eye Examination Mobile Medical App device is adulterated under section 501(f)(1)(B) of the Act, 21 U.S.C. § 351(f)(1)(B), because you do not have an approved application for premarket approval (PMA) in effect pursuant to section 515(a) of the Act, 21 U.S.C. § 360e(a), or an approved application for an investigational device exemption (IDE) under section 520(g) of the Act, 21 U.S.C. § 360j(g)," the letter states.  
 
The FDA stated that the On-Line Opternative Eye Examination Mobile Medical App Device is also misbranded because the company did not notify the agency of its intent to introduce the device into commercial distribution.
 
In the letter, which was dated October 30, 2017, the FDA requested 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.
 
The full letter can be viewed here.

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