Devices

iRhythm Hit with 483 After July Inspection

FDA has issued iRhythm Technologies (San Francisco, CA) a Form FDA-483 after an inspection last month cited three GMP deficiencies. The company has been working to resolve issues raised in a Warning Letter last year, and the latest inspection presumably is a follow-up action to evaluate the company’s progress.

The Warning Letter determined that the company’s ZIO AT system was an unapproved device because it was cleared for long-term monitoring of arrhythmia events for non-critical care patients, but marketing materials describe different indications with changes to the device that would require a new 510(k) submission. 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.

The recent inspection cited iRhythm for not adequately analyzing over 4,000 complaints received from 5/2022 to 7/2024 related to its certified cardiographic technician (CCT) personnel operations, including issues related to CCT personnel misreading arrhythmia data and providing misclassified data to end users for diagnosis purposes. The FDA-483 says that the firm “is not adequately analyzing these complaints, issues, or events to identify the rate of occurrence or detect recurring quality problems. You also have not initiated any corrective and preventive actions to investigate the cause or identify the action(s) needed to correct and prevent the recurrence of this quality problem.”

Additionally, FDA cited iRhythm for not filing medical device reporting forms within 30 days of becoming aware of information that reasonably suggests that a marketed device (e.g., Zio AT, Zio XT, Zio Monitor, and Zeus System Software medical devices) has malfunctioned and would be likely to cause or contribute to a death or serious injury if the malfunction were to recur.

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Gupta Raises Concerns About Overton’s Independence, Ideology

Overton Confirmation Remains Uncertain After Senate Hearing

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome