FDA WARNING_LETTER - Opternative Inc

On October 30, 2017, the FDA issued a Warning Letter to Opternative, Inc. regarding their On-Line Opternative Eye Examination Mobile Medical App device. The FDA determined the device is being marketed in the U.S. without marketing clearance or approval, violating the Federal Food, Drug, and Cosmetic Act.

The device is considered adulterated under section 501(f)(1)(B) of the Act because Opternative, Inc. lacks an approved premarket approval (PMA) application or an investigational device exemption (IDE). It is also misbranded under section 502(o) for failure to notify the FDA of intent to introduce the device into commercial distribution, as required by section 510(k). Opternative, Inc. was previously informed on June 15, 2016, that a premarket submission was required.

The FDA requests Opternative, Inc. immediately cease activities resulting in the misbranding or adulteration of the device, including commercial distribution. The company must provide a written response within fifteen business days detailing corrective actions, a plan to prevent recurrence, and a timetable for implementation if corrections extend beyond fifteen days. Failure to comply may result in regulatory actions such as seizure, injunction, civil money penalties, and impact on federal contracts.