FDA Cracks Down on Online Eye-Exam Company

This past October, the Food and Drug Administration issued a warning letter to Opternative, a company specializing in providing online eye-exams. The FDA has now made its letter public and set up a meeting with Opternative in July to make sure the company is in regulatory compliance.
The crux of the letter is that the FDA considers theses eye exams to be a Class 2 device, which requires premarket approval. Because the agency considers any device “intended for use in the diagnosis of disease or other conditions or in the cure, mitigation, treatment, or prevention of disease, or to affect the

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