The FDA issued a Warning Letter to RightEye, LLC, on January 31, 2023, in regards to the company’s misbranding and adulteration of its RightEye Vision System.
Tell me about this vision system.
The RightEye Vision System is a portable, noninvasive eye-tracking system that tests, records, analyzes, and reports minute eye movement patterns unattainable in observation-only exams.
The class II nystagmograph medical device was 501(k) cleared by the FDA in 2018 for recording, viewing, and analyzing eye movements to identify visual tracking impairments in human patients.
Explain the purpose of a Warning Letter.
A warning letter issued by the FDA is an official notification to a specific manufacturer or organization that has violated a rule in a federally regulated activity. It’s generally considered informal and advisory, and not a final action on which it can be sued. However, the FDA expects voluntary compliance with the law.
Now talk about these violations.
Following an inspection in June-July 2022, the FDA observed that RightEye’s vision system was misbranded under the Federal, Food, Drug and Cosmetic Act (FDCA) due to promotions that were beyond its cleared indications for use; a failure or refusal to furnish required material and information; and adulterated (corrupt) as a result of failing to conform with the medical device good manufacturing (GMP) requirements.
While the company responded to the FDA’s initial observations, the FDA determined the response to be inadequate.
Tell me about the promotions.
The FDA cited specific examples of RightEye’s inaccurate device promotions, including claims that it could treat a range of neurological disorders and detect vision abnormalities related to attention-deficit/hyperactivity disorder (ADHD), mild traumatic brain injury (mTBI), or Parkinson’s disease.
The system was not cleared for use in assessing or diagnosing those conditions, and the FDA cautioned that using the device to diagnose such disorders could lead to delayed diagnosis or treatment, misdiagnosis, and serious secondary injuries.
How about the adulterations?
The FDA stated that RightEye did not have an approved premarket approval (PMA) or an investigational device exemption (IDE) application for the vision system. Further, the company’s manufacturing, storage, packing, and installation of the system did not meet GMP requirements.
See here for the full letter.
Anything else?
The FDA determined that the company had not exhibited any plans to correct any of its actions and warned of severe consequences—such as seizure, injection, or civil monetary penalties— if they are not addressed. Further, approval of class III device premarket approval applications could be delayed.
Now what?
RightEye was advised to take immediate action in addressing the violations, including notifying the FDA (within 15 days of receiving the letter) of its plans to address the violations and prevent them from occurring again.