Home » FDA Warns Opternative for Marketing Eye Examination App Without Clearance
FDA Warns Opternative for Marketing Eye Examination App Without Clearance
Devices Inspections and Audits
The FDA handed Chicago-based Opternative a warning letter after a review of its website found it was marketing an online eye examination mobile medical app device without marketing clearance.
The agency cited the firm for failing to secure pre-market approval for the app as well as for misbranding because the company failed to notify the FDA it was introducing the device to the market.
The FDA demanded that Opternative immediately cease marketing the product.