Devices

iRhythm Technologies Cited for Unapproved Device

David McFarland

— 1 min read
Share

A 7/25-8/12/22 FDA inspection at iRhythm Technologies in Cypress, CA, determined that the company manufactures the ZIO AT system, which it says is an unapproved medical device. A 5/25 Warning Letter says the system is intended to continuously record and report patient symptomatic and asymptomatic cardiac events and continuous electrocardiogram information.

The letter says the system was cleared for long-term monitoring of arrhythmia events for non-critical care patients where real-time monitoring is not needed as reporting timeliness is not consistent with life-threatening arrhythmias. But the marketing materials, the letter says, describe different indications with changes to the device that would require a new 510(k) submission. FDA says the system is adulterated because the company doesn’t have an approved PMA or IDE in place, and is misbranded because the company did not notify the agency of its intent to introduce the device into commercial distribution.

The letter also addresses labeling violations and these Quality System Regulation violations:

  • failing to adequately establish and maintain procedures for implementing corrective and preventive action;
  • failing to adequately establish procedures for receiving, reviewing, and evaluating complaints by a formally designated unit; and
  • failing to validate a process to a high degree of assurance.

Medical device reporting violations were listed as:

  • failing to submit a report to FDA no later than 30 calendar days after the day that iRhythm Technologies received or otherwise became aware of information, from any source, that reasonably suggests that a device that it markets may have caused or contributed to a death or serious injury;
  • failing to submit a medical device report (MDR) for an event in which the device has malfunctioned and is likely to cause or contribute to death or serious injury if the malfunction recurred; and
  • failing to adequately develop, maintain, and implement written MDR procedures.

iRhythm was told to promptly correct the violations and to respond with a list of specific steps it has taken to correct the violations and prevent their recurrence, with documentation of the corrections and a schedule for completing the work.

Read more