AOA argues that Opternative test should be removed from the market.
The American Optometric Association (AOA) has asked that the Food and Drug Administration (FDA) take legal action against an online vision test being marketed by Opternative, Inc., which the AOA says has not been subjected to the testing and pre-market approvals frequently required of new medical device technology.
Currently, Opternative’s app allows patients between the ages of 18 and 40 in 33 states to take a 25-minute eye test and then receive a prescription for contact lenses or glasses. And the company has the attention of big-time investors, who recently poured $6 million into it.
But the AOA is taking exception to the Opternative test because it yields the prescriptions “without any examination of the patient by an eyecare professional and without taking into account the patient’s overall medical condition,” according to a release from the association.
In a complaint now before the FDA, the AOA 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 federal requirements for medical devices under the Food, Drug and Cosmetic Act.
“The AOA – as an authority on quality care and an advocate for our nation's health – is committed to ensuring that the public is not misled, essential care is not diverted or dangerously delayed, and patient safety laws are not ignored," says Dr. Steven A. Loomis, O.D., AOA president. “No product or company can or should be allowed to operate outside appropriate federal oversight when vision and overall health are at stake. That’s why the AOA is urging the government to fully enforce basic patient safety and consumer protection safeguards.”
In the release, the AOA also notes that the state of Michigan recently issued a cease-and-desist order against Opternative for violating the state consumer protection law, and that other states are considering possible responses to safeguard public health. For its part, Opternative is making an effort to fight against individual state bans.
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