An FDA inspection claims that eye-tracking biomarker developer RightEye misbranded and adulterated its medical device.
The agency wrote in a letter, dated Dec. 20, 2022, that it inspected RightEye’s Bethesda, Maryland facility over 10 days in June and July 2022. In this inspection, it declared the RightEye Vision System a Class II Nystagmograph medical device.
RightEye’s system records, views and analyzes eye movements in support of diagnosing visual tracking impairments. This classification came because this product is intended for use in the diagnosis of disease or other conditions. It can also offer use in the cure, mitigation, treatment or prevention of disease, or affect the structure or function of the body.
The company’s last announcement of a regulatory nod came in December 2019. RightEye said it received FDA breakthrough device designation for eye tracking to help uncover Parkinson’s disease. The system originally received FDA clearance in October 2018.
In May 2022, the company announced that it surpassed 5 million patient tests administered using the RightEye Vision System.
Allegations of adulterating and misbranding against RightEye
The FDA determined RightEye adulterated its system because it does not have an approved premarket approval application in effect. It also failed to garner an investigational device exemption (IDE).
According to the FDA, methods, facilities or controls used for manufacturing, storage, packing or installation failed to meet good manufacturing practices requirements. RightEye failed to do this on multiple counts, the agency said. These included design requirements, design history, handling complaints and more.
Specifically, the FDA cleared the system with indications for “recording, viewing, and analyzing eye movements in support of identifying visual tracking impairment in human subjects.” However, RightEye branded the device as intended to improve vision problems, FDA alleged. The agency also said the company promoted the device for measuring nad analyzing eye movements for the broader genre of “neurological disorders.”
Neurological disorders, including Parkinson’s disease, would constitute a major change or modification to its intended use. FDA said RightEye lacks clearance or approval for such use. Off-label use of the system could interfere with traditional treatments and a delay may put patients at risk.
The FDA said this raises safety concerns.
Additionally, the agency determined the misbranding of the RightEye Vision System came through its commercialization. The FDA said RightEye introduced or delivered introduction into interstate commerce the device with major changes or modifications. This introduction came without submission for a new premarket notification to the FDA.
The FDA’s outlook
According to the FDA, RightEye offered responses to its investigation, but the agency found them inadequate. The letters sent by the company indicated a full assessment planned for its quality system, FDA said. However, they failed to include plans to implement corrective actions.
The FDA told RightEye to “take prompt action” to address the violations identified in its letter. It may take regulatory action without further notice if the company fails to do so. These actions may include seizure, injunction and civil money penalties.
FDA concluded its letter with this statement:
“Finally, you should know that this letter is not intended to be an all-inclusive list of the violations at your firm’s facility. It is your firm’s responsibility to ensure compliance with applicable laws and regulations administered by FDA. The specific violations noted in this letter and in the Inspectional Observations, FDA 483, issued at the close of the inspection may be symptomatic of serious problems in your firm’s manufacturing and quality management systems. Your firm should investigate and determine the causes of any violations and take prompt actions to address any violations and bring the products into compliance.”
RightEye did not immediately respond to a request for comment. This story may be updated.