Devices

RightEye Promoting Off-Label Use: FDA

David McFarland

— 1 min read
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FDA says a 6/28-7/8/22 inspection at RightEye, LLC, in Bethesda, MD, determined the firm is promoting its RightEye Vision System, a Class 2 nystagmograph medical device, for off-label uses to improve vision problems and measure and analyze eye movements for “neurological disorders.” A just-released 12/20/22 Warning Letter says the firm’s device is adulterated because RightEye does not have an approved PMA application or IDE in effect. The device also is misbranded, FDA says, because the firm introduced it or delivered it for introduction into interstate commerce for commercial distribution with major changes or modifications to the intended use without submitting a new PMA to FDA.

“The RightEye Vision System has not been cleared to ‘improve vision problems,’” the letter says. “Such off-label use of this device may interfere with traditional standard of care treatment and a delay may put patients at risk.” The letter also says the device has not been cleared to aid in the assessment or diagnosis of neurodevelopmental conditions.

FDA further says the device is misbranded because the firm did not label each version or model of a device with a unique device identifier.

Finally, the letter says the device is adulterated due to a failure to conform to current good manufacturing practice requirements of the Quality System regulation in these ways:

  • failing to establish and maintain procedures to control the design of the device to ensure that specified design requirements are met;
  • failing to establish and maintain a device history file that contains or references the records necessary to demonstrate that the design was developed according to the approved design plan and design control requirements;
  • failing to establish and maintain procedures for receiving, reviewing, and evaluating complaints; and
  • failing to establish and maintain procedures to control product that does not conform to specified requirements.

FDA says the firm’s response to each observation on the form FDA-483 that it planned to conduct a full assessment of its Quality System was inadequate in that it did not include plans to implement specific corrective actions.

RightEye was told to respond with a list of specific actions it has taken to address the violations and prevent their recurrence, with documentation of the actions and a schedule for completing the corrections.

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