The FDA sent Opternative a warning letter to stop marketing their mobile app because it was “adulterated” and “misbranded”. The letter was initially sent in October 2017 but was recently made public.⠀
Why did the FDA send the warning?
Because Opternative didn’t apply for marketing clearance or get medical device approval. This is in violation of the Federal Food, Drug, and Cosmetic Act.⠀
Remind me, what is Opternative?
It’s a health-tech startup out of Chicago where $50 can get you an eye exam online, $60 if you want both glasses AND contacts. ⠀
Opternative said they responded to the letter and are working closely with the FDA on the matter. (via)
It’s a health-tech startup out of Chicago where $50 can get you an eye exam online, $60 if you want both glasses AND contacts. ⠀
Opternative said they responded to the letter and are working closely with the FDA on the matter. (via)
