AOA Files FDA Complaint Against Online Vision Test

American Optometric Association

Today, the American Optometric Association (AOA) reportedly asked the US Food and Drug Administration (FDA) to take legal action against an online vision test being marketed by Opternative, Inc. without the type of testing and pre-market approvals frequently required of new medical device technology.

According to the AOA, the Opternative test produces a prescription for eyeglasses or contact lenses without any examination of the patient by an eye care professional and without taking into account the patient's overall medical condition. The AOA's complaint challenges claims made by Opternative about its product's capabilities and calls for enforcement action to remove it from the market until it can be shown to meet all appropriate Federal requirements for medical devices under the Food, Drug and Cosmetic Act, including safety and effectiveness.

Click here to read the full press release.

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