ZYTO Technologies Racks Up Warning Letter and 483

Medical device maker ZYTO Technologies received an FDA warning letter May 8 for labeling and promotion issues that stemmed from a Dec. 3, 2014, 11-item Form 483 for numerous quality system deviations.

QS deviations cited in the 483 included not establishing corrective and preventive action procedures  or design control procedures for the ZYTO hand cradle, a Class II skin measurement device, and the ZYTO laser and tower accessories.

The firm also did not establish design change procedures or procedures for receiving, reviewing and evaluating complaints.  It also did not have procedures in place to establish whether the product conformed to specified requirements, nor were suppliers evaluated on their ability to meet specified requirements, according to the 483.

The firm also did not conduct risk analysis or quality audits for its products nor did it maintain a device master record or procedures for training and identifying training needs.

Following the firm’s Dec. 22, 2014, response, the FDA sent a warning letter to the firm for labeling and promotion issues and for making major changes without submitting a new premarket notification to the FDA.

The FDA notes in the warning letter that the hand cradle was cleared to measure galvanic skin response, but that the firm was promoting the device for wider indications and citing clinical studies outside of the approved indication.

In response to the warning letter, the firm issued a statement that said it was working with the agency to “clarify and modify promotional language associated with the labeling of the ZYTO Hand Cradle.”

The firm said the November 2014 inspection was its first FDA inspection, which covered all aspects of its manufacturing processes as well as all messaging relating to the ZYTO medical device.

“We welcome this input from the FDA,” said ZYTO President Kami Howard. “We have a strong desire to represent ZYTO products to our customers accurately and clearly. We have already addressed each specific issue raised by the FDA.”

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