Devices

Multiple Violations at Vitang Technology

David McFarland

— 2 min read
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A 1/24-1/31 FDA inspection at Vitang Technology in Tustin, CA, determined that the firm is marketing the misbranded and adulterated UniSmile Clear Aligner, a Class 2 dental aligner that was cleared under a 510(k). A 6/12 Warning Letter says the medical device is misbranded because Vitang made changes to it without submitting a new 510(k).

Specifically, the letter says, the firm changed from using cleared software to design treatment plans to using non-cleared software.

“A change in orthodontic treatment planning software is a change that could significantly affect the safety and effectiveness of the device,” FDA says. It says the change made by Vitang “has the potential to affect the proposed treatment protocol as well as the dimensions, configurations, and applied forces of the UniSmile Clear Aligners, and affect the clinical outcome,” requiring submission of a new 510(k), which Vitang did not do.

The letter says the device also is adulterated due to these Quality System Regulation violations:

  • failing to adequately establish and maintain procedures for receiving, reviewing, and evaluating complaints by a formally designated unit;
  • failing to validate software used as part of the quality system for its intended use according to an established protocol;
  • failing to establish and maintain procedures to ensure that all purchased or otherwise received products and services conform to specified requirements, including evaluation of suppliers, contractors, and consultants;
  • failing to establish and maintain procedures for monitoring and control of process parameters for validated processes to ensure that the specified requirements continue to be met, and failing to ensure that when the results of a process cannot be fully verified by subsequent inspection and test, the process shall be validated with a high degree of assurance and approved according to established procedure, including the validation of major equipment;
  • failing to adequately establish and maintain procedures to ensure equipment is routinely calibrated, inspected, checked, and maintained;
  • failing to establish procedures for device history records;
  • failing to document the results and/or dates of management reviews; and
  • failing to document personnel training.

FDA says that some of the firm’s responses to the inspection observations were inadequate, while the adequacy of the other responses could not be determined.

The letter says the firm’s UniSmile Clear Aligner System is also misbranded because a representation on the Vitang Web site creates a misleading impression of official approval of the device.

Vitang was told to take prompt action to address violations identified in the letter and to respond with a list of specific steps it has taken to address the violations and prevent their recurrence, with documentation of the corrective actions and a schedule for completing the corrections.

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