WARNING LETTER

RightEye, LLC MARCS-CMS 643192 — December 20, 2022

Delivery Method:: VIA Electronic Mail
Product:: Medical Devices

Recipient:: Recipient Name

Adam T. Gross; Recipient Title

Chief Executive Officer; RightEye, LLC; 7979 Old Georgetown Road Suite 801
Bethesda, MD 20814-2454
United States; adam@righteye.com

Issuing Office:: Division of Medical Device and Radiological Health Operations East; United States; Center for Devices and Radiological Health

WARNING LETTER
CMS# 643192

December 20, 2022

Dear Mr. Gross:

During an inspection of your firm located at 7979 Old Georgetown Road, Suite 801, Bethesda, MD 20814-2454 on June 28 through July 08, 2022, investigators from the United States Food and Drug Administration (FDA) determined that your firm is a manufacturer of the RightEye Vision System, a Class 2 Nystagmograph medical device under 21 CFR 882.1460. RightEye is intended for recording, viewing, and analyzing eye movements in support of diagnosing visual tracking impairment in human subjects. Under section 201(h) of the Federal Food, Drug, and Cosmetic Act (the Act), 21 U.S.C. § 321(h), this product is a 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.

We received a response from you, dated July 29, 2022, and responses from Melissa Hunfalvay, Chief Science Officer & Co-Founder, dated October 07, 2022, and December 13, 2022, concerning our investigator’s observations noted on the Form FDA 483 (FDA 483), List of Inspectional Observations, that was issued to your firm. We address these responses below, in relation to each of the noted violations.

The inspection revealed that the RightEye Vision System device is adulterated under section 501(f)(1)(B) of the Act, 21 U.S.C. § 351(f)(1)(B), because your firm does not have an approved application for premarket approval (PMA) in effect pursuant to section 515(a) of the Act, 21 U.S.C. § 360e(a), or an approved application for an investigational device exemption (IDE) under section 520(g) of the Act, 21 U.S.C. § 360j(g) for the device as described and marketed. Additionally, the RightEye Vision System is also misbranded under section 502(o) the Act, 21 U.S.C. § 352(o), because your firm introduced or delivered for introduction into interstate commerce for commercial distribution this device with major changes or modifications to the intended use without submitting a new premarket notification to FDA as required by section 510(k) of the Act, 21 U.S.C. § 360(k), and 21 CFR 807.81(a)(3)(ii).

Specifically, the RightEye Vision System was cleared under K181771 with the following indications: “recording, viewing, and analyzing eye movements in support of identifying visual tracking impairment in human subjects.” However, your firm’s promotion of the device provides evidence that the device is intended to improve vision problems and measure and analyze eye movements for the broader genre of “neurological disorders,” including Parkinson’s disease, which would constitute a major change or modification to its intended use for which your firm lacks clearance or approval. Examples include:

“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.” ”

The RightEye Vision System has not been cleared to “improve vision problems.” Such off-label use of the device may interfere with traditional standard of care treatment and a delay may put patients at risk. For example, if the device were used for amblyopia treatment in children instead of clinical standard of care (e.g., patching), the critical time interval when such treatment will be effective may be lost. This raises significant safety concerns.

In addition, the RightEye Vision System has not been cleared to aid in the assessment or diagnosis of neurodevelopmental conditions (e.g., Attention-Deficit/Hyperactivity Disorder or “ADHD”), mild traumatic brain injury (mTBI) or concussion, or neurodegenerative diseases (e.g., Parkinson's disease). Your firm links the device’s utility to track eye movements to the diagnosis of specific neurological conditions from eye movement tracking, which falls outside the cleared indications for use of the device. For example, as identified above, your firm states that “RightEye EyeQ tests help health care providers assess patients’ brain health, visual dysfunction, concussions, reading disorders.” While your firm notes that vision problems may exist in certain patients with these conditions, FDA has not yet evaluated whether this device can detect vision abnormalities specific to these conditions. Such off-label use to aid in the diagnosis of ADHD, mTBI, or Parkinson’s disease may result in misdiagnosis or a delay in diagnosis due to a clinician's reliance on inaccurate or irrelevant information provided by the device. This may result in delayed treatment or care in the cases of ADHD and Parkinson’s disease. In the case of mTBI, this may result in serious further injury if an initial injury is misdiagnosed or undiagnosed, the patient therefore is not appropriately managed and does not take adequate care or precautions, and the patient suffers a second mTBI. Second impact syndrome, although rare when patients are properly managed, is most often fatal.

We reviewed your firm’s responses and concluded they are not adequate. Your letters indicated that a full assessment of your Quality System is planned but did not include your plans to implement specific corrective actions regarding off-label promotion of your device beyond its cleared indications for use.

In addition, your RightEye Vision System device is misbranded within the meaning of section 502(t)(2) of the Act, 21 U.S.C. § 352(t)(2), in that there was a failure or refusal to furnish any material or information required by or under section 519 of the Act, 21 U.S.C. § 360i, respecting the device. In particular, 21 CFR 830.300(a) and 830.320(b), both of which were promulgated under section 519 of the Act, among other provisions, require, with exceptions not relevant here, that the labeler of a device submit electronically to FDA’s Global Unique Device Identification Database (GUDID) the information required by 21 CFR 830, subpart E, for each version or model required to bear a UDI. Your firm is a “labeler” within the meaning of 21 CFR 830.3 and has not submitted to GUDID any information required by 21 CFR 830, subpart E, respecting this device. The failure or refusal to furnish any notification or other material or information required by or under section 519 of the Act, 21 U.S.C. § 360i, also constitutes a prohibited act under section 301(q)(1)(B) of the Act, 21 U.S.C. § 331(q)(1)(B).

This inspection also revealed that this device is adulterated within the meaning of section 501(h) of the Act, 21 U.S.C. § 351(h), in that the methods used in, or the facilities or controls used for, its manufacture, packing, storage, or installation are not in conformity with the current good manufacturing practice requirements of the Quality System regulation found at Title 21, Code of Federal Regulations (CFR), Part 820.

These violations include, but are not limited to, the following:

1. Failure to establish and maintain procedures to control the design of the device to ensure that specified design requirements are met, as required by 21 CFR 820.30. Specifically, your firm has no written design control procedures.

2. 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, as required by 21 CFR 820.30(j).

Specifically, your DHF for the RightEye Vision System device does not include nor reference the location of supporting documentation related to design and development planning, design input, design output, design review, design verification, design validation, risk management/risk analysis, and design transfer.

3. Failure to establish and maintain procedures for receiving, reviewing, and evaluating complaints, as required by 21 CFR 820.198(a). Specifically, your complaint handling procedure, Complaint Handling Document # RE_SOP_1.0.2 Complaint Handling Rev. 1.0.2, dated 06/24/2022, does not address the requirement that all complaints be evaluated to determine whether the complaint represents an event which is required to be reported to FDA under 21 CFR 803, Medical Device Reporting. Additionally, your complaint handling procedure does not address reviewing and evaluating all complaints to determine whether an investigation is necessary, nor does it require that when no investigation is made, a record be maintained that includes the reason no investigation was made.

Furthermore, 7 of the 7 complaint files reviewed during this inspection were not evaluated to determine whether the complaint represents an event which is required to be reported to FDA under 21 CFR 803, Medical Device Reporting; and were not reviewed or evaluated to determine whether an investigation is necessary, and no investigation was made.

4. Failure to establish and maintain procedures to control product that does not conform to specified required, as required by 21 CFR 820.90. Specifically, you have not established procedures concerning the control of nonconforming product.

5. You have not established or maintained the requirements, including quality requirements, that must be met by suppliers, contractors, and consultants. For example, your firm relies on suppliers to contract manufacture critical hardware of the RightEye Vision System device, per your component specifications.

Failure to establish and maintain the requirements, including quality requirements, that must be met by suppliers, contractors, and consultants, as required by 21 CFR 820.50(a).

We reviewed your firm’s responses and concluded they are not adequate. Your letters indicated that a full assessment of your Quality System is planned but did not include your plans to implement specific corrective actions.

Your firm should take prompt action to address any violations identified in this letter. Failure to adequately address this matter may result in regulatory action being initiated by the FDA without further notice. These actions include, but are not limited to, seizure, injunction, and civil money penalties.

Other federal agencies may take your compliance with the FD&C Act and its implementing regulations into account when considering the award of federal contracts. Additionally, should FDA determine that you have Quality System regulation violations that are reasonably related to premarket approval applications for Class III devices, such devices will not be approved until the violations have been addressed. Should FDA determine that your devices or facilities do not meet the requirements of the Act, requests for Certificates to Foreign Governments (CFG) may not be granted.

Please notify this office in writing within fifteen business days from the date you receive this letter of the specific steps your firm has taken to address the noted violations, as well as an explanation of how your firm plans to prevent these violations, or similar violations, from occurring again. Include documentation of the corrections and/or corrective actions (which must address systemic problems) that your firm has taken. If your firm’s planned corrections and/or corrective actions will occur over time, please include a timetable for implementation of those activities. If corrections and/or corrective actions cannot be completed within fifteen business days, state the reason for the delay and the time within which these activities will be completed. Your firm’s response should be comprehensive and address any violations included in this Warning Letter. If you believe that your products are not in violation of the FD&C Act, include your reasoning and any supporting information for our consideration as part of your response.

Your firm’s response should be sent to: Gina Brackett, Director of Compliance Branch, at oradevices1firmresponse@fda.hhs.gov. Refer to CMS # 643192 when replying. If you have any questions about the contents of this letter, please contact: Katelyn Staub-Zamperini, Compliance Officer, at (412) 644-3394 ext. 20 or katelyn.staub-zamperini@fda.hhs.gov.

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.

Sincerely yours,
/S/

Joseph Matrisciano Jr.
Program Division Director
Office of Medical Device and Radiological Health
Division 1/East

/S/

CAPT Nina Mezu-Nwaba, PharmD, MPH, MSc
Deputy Office Director
OHT 5: Office of Neurological & Physical Medicine Devices
Office of Product Evaluation and Quality
Center for Devices and Radiological Health