FDA WARNING_LETTER - RIGHTEYE, LLC - July 08, 2022

On December 20, 2022, the FDA issued a Warning Letter to RightEye, LLC, following an inspection from June 28 to July 8, 2022. The inspection revealed that the RightEye Vision System, a Class 2 Nystagmograph medical device, is adulterated and misbranded.

The device is adulterated because RightEye lacks an approved Premarket Approval (PMA) or Investigational Device Exemption (IDE) for the device as marketed. It is misbranded under section 502(o) for major changes to its intended use without submitting a new premarket notification (510(k)). Specifically, the device, cleared for "identifying visual tracking impairment," is promoted to "improve vision problems" and assess "neurological disorders" like Parkinson's disease, ADHD, and mTBI, which are uncleared indications. These off-label uses raise significant safety concerns, including delayed or misdiagnosis and potential for serious injury.

Additionally, the device is misbranded under section 502(t)(2) for failing to submit required information to the Global Unique Device Identification Database (GUDID) per 21 CFR 830.300(a) and 830.320(b).

The device is also adulterated under 501(h) due to non-conformity with Quality System (QS) regulation