![]() ![]() ![]() “We have never said we are approved by the FDA, and by stating that we are registered with the FDA is in no way insinuating or trying to mislead people into thinking that we are approved by the FDA,” Dallek said. He said the fact that the AOA said the company’s claims are misleading is “misleading in and of itself.” “Consistent with our mission to help safeguard public health, wherever we find violations of federal or state law, our AOA and state associations will be pressing for full enforcement.”ĭallek said Opternative is registered with the FDA and follows all rules for the technology being a Class I medical device. Steven Loomis, president of the AOA, told Healthline in an email. “We’re concerned about abuses of technology’s promise and false claims that can leave patients misled, misinformed, or confused,” Dr. However, the American Optometric Association (AOA) has challenged the Opternative platform, saying in a statement that the FDA-related claims about the technology are misleading to consumers.Īssociation officials said they welcome new technology, but they also are concerned about misuse of any new products.
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