On January 31, 2023, the U.S. Food and Drug Administration (FDA) published a Warning Letter[1] to RightEye, LLC (RightEye), the manufacturer of the RightEye Vision System, for misbranding and adulteration. The RightEye Vision System is a Class II Nystagmograph medical device which is cleared under its 510(k) notification for the following indication: “recording, viewing, and analyzing eye movements in support of identifying visual tracking impairment in human subjects.”[2] 

The violations were observed during an FDA inspection on June 28-July 8, 2022 on the Form FDA 483. RightEye responded on July 29, 2022, and FDA concluded the responses were inadequate. In the Warning Letter, FDA wrote that, for the reasons discussed below, the device was: (i) misbranded due to promotion beyond its cleared indications for use, (ii) misbranded due to a failure or refusal to furnish required material and information, and (iii) adulterated due to a failure to conform with medical device good manufacturing practice (GMP) requirements.

Misbranding: Promotion of Off-Label Indications

FDA stated that the RightEye Vision System was misbranded under the Federal, Food, Drug and Cosmetic Act (FDCA) because RightEye introduced the device into interstate commerce with major changes or modifications to the intended use without submitting the requisite new premarket notification to FDA.[3] RightEye’s promotion of the RightEye Vision System implied that the device was intended to improve vision problems and measure and analyze eye movements for “neurological disorders” generally, including ADHD, mTBI (mild traumatic brain injury), and Parkinson’s disease. This promotion constituted a major change from its intended use, stated above, without FDA clearance or approval. For example, RightEye made the following statements:

• “Uncover & Improve Vision Problems That Interfere With Reading and Learning”
• “One in four children has a vision problem that affects learning—a vision problem that is often misinterpreted as disinterest, sleepiness, dyslexia, or ADHD. But in just a few minutes the RightEye™ system exposes vision and brain health in ways not possible from standard eye tests, gifting you with the opportunity to change your child’s life forever.”
• “RightEye EyeQ tests help health care providers assess patients’ brain health, visual dysfunction, concussions, reading disorders, and athletic performance issues by following an evidence-based, metrics-driven methodology.”
• “Research has demonstrated that patients with Parkinson’s disease exhibit persistent ocular tremors that prevent stability during fixation. Through oculomotor testing, the RightEye Vision System is designed to identify these ocular tremors, which may not only support doctors in diagnosing of the disease but may also help detect the disease at an earlier stage since ocular tremors are often detectable well before other commonly recognized symptoms of the disease surface.”

FDA noted that such statements posed safety concerns as they could interfere with and delay the traditional standard of care treatment. Specifically, FDA explained that the promotion could prevent patients from seeking appropriate and timely treatment modalities approved by FDA for the indicated treatment.

FDA had not evaluated whether the device could detect vision abnormalities specific to ADHD, mTBI or Parkinson’s disease nor had the device been cleared to aid in the assessment or diagnosis of those conditions. FDA emphasized off-label use to aid in the diagnosis of non-indicated disorders can result in misdiagnosis, delay in diagnosis, delayed treatment or care, and serious secondary injuries. For example, off-label use to diagnose ADHD, mTBI or Parkinson’s disease could result in misdiagnosis or a delay in diagnosis. In the cases of ADHD and Parkinson’s disease, this may result in delayed treatment or care. In the case of mTBI, a second mTBI, which is often fatal, may occur if the initial injury is misdiagnosed or undiagnosed. FDA found RightEye had not provided any plans to implement specific corrective actions regarding off-label promotion of its device beyond its cleared indications for use.

Misbranding: Failure to Submit Information

Under the implementing regulations of the FDCA, “labelers” of a device must submit certain information for unique device identification to FDA’s Global Unique Device Identification Database for each version or model required to bear a Unique Device Identifier.[4] FDA found RightEye had not submitted any required information nor had it indicated any plans to implement specific corrective actions regarding its product labels/labeling.

Adulteration

FDA wrote the RightEye Vision System was adulterated for multiple reasons. First, RightEye did not have an approved application for premarket approval or an approved application for investigational device exemption for the RightEye Vision System.[5] Second, the methods, facilities or controls used for the manufacture, storage, packing or installation of the RightEye Vision System failed to meet GMP requirements on multiple counts.[6] Those violations included:

• Failure to establish and maintain procedures to control the design of the device to ensure that specified design requirements are met. Specifically, no written design control procedures.
• Failure to establish and maintain a design history file (DHF) that contains or references the records necessary to demonstrate that the design was developed in accordance with the approved design plan and design control requirements. Specifically, the DHE for the RightEye Vision System device does not include nor reference the location of supporting design documentation.
• Failure to establish and maintain procedures for receiving, reviewing, and evaluating complaints. Specifically, the complaint handling procedures do not address that all complaints be evaluated to determine whether complaint is required to be reported or that all complaints be evaluated to determine whether an investigation is necessary.
• Failure to establish and maintain procedures to control non-conforming product. Specifically, no procedures concerning the control of nonconforming product were established.
• Failure to establish or maintain the requirements, including quality requirements, that must be met by suppliers, contractors, and consultants. Critical hardware of the device is manufactured by contracted suppliers. 

FDA determined RightEye had not demonstrated any plans to implement specific corrective actions.

Additional Considerations

The Warning Letter indicated that a failure to address the noted violations could have serious and varying consequences. Failure to adequately address the notice could result in regulatory action, including seizure, injunction and civil monetary penalties. Non-compliance with the FDCA could impact the award of federal contracts and grant of Certificates to Foreign Governments. FDA’s determination of Quality System violations related to Class III device premarket approval applications could delay the approval of such devices.

FOOTNOTES

[1] Untitled letter available here: https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/righteye-llc-643192-12202022.

[2] K181771 Indications for Use available here: https://www.accessdata.fda.gov/cdrh_docs/pdf18/K181771.pdf.

[3] See 21 U.S.C. § 352(o), 21 U.S.C. § 360(k), 21 CFR 807.81(a)(3)(ii).

[4] See 21 U.S.C. § 352(t)(2), 21 U.S.C. § 360i, 21 CFR 830.

[5] See 21 U.S.C. § 351(f)(1)(B).

[6] See 21 CFR 820.