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# Opternative Marketing Unapproved Medical Device App
- URL: https://www.fdaweb.com/opternative-marketing-unapproved-medical-device-app/
- Published: 2018-03-14T12:00:00.000Z
- Updated: 2026-09-14T23:53:20.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5140977

FDA says that Opternative, Inc., Chicago. IL, is marketing its On-Line Opternative Eye Examination Mobile Medical App device in the U.S. without FDA marketing clearance or approval. A just-released 10/30/17 [Warning Letter](https://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2017/ucm600029.htm?ref=fdaweb.com) says the product is considered a medical device because it is 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 structure or any function of the body.

The letter says the app is adulterated because there is no approved PMA or IDE in place for it and is misbranded because the company did not notify FDA of its intention to introduce the device into commercial distribution.

At a 6/15/16 meeting at FDA, the company was informed that the app requires a premarket submission so the agency can evaluate its safety and effectiveness, the letter says.

The company was told to cease activities that result in the adulteration or misbranding of its device and take prompt action to correct the violations and prevent their recurrence. It was to notify FDA of the specific steps it has taken, along with documentation of each step and a timetable for completion.