FDA 483 - iRhythm Technologies, Inc. - July 31, 2024

The FDA Form 483 details observations from an inspection of a facility, identifying significant deficiencies in quality system and manufacturing controls.

**Observation 1** highlights inadequate complaint handling procedures. The firm failed to establish written protocols for complaints related to skin irritation and abrasions from the Zio XT device. Ten out of twelve reviewed complaints (86%) for skin irritation, categorized as highest risk, breached the firm's control limit, yet no CAPA or impact assessment was initiated. There's no written protocol for Territory Managers regarding complaint handling, monitoring, or escalation for CAPA, MDR, or recalls. Specific examples include pediatric patients experiencing severe skin reactions, and cases of blisters, burning, and allergic reactions, with no CAPA or impact assessment completed. The firm's Adverse Event Reporting procedure lacks criteria for submitting MDRs in non-severe cases not requiring medical intervention. Furthermore, the firm has not performed required "ZTicket Searches" for potentially missed complaints since December 2022, and handwritten complaints on returned devices were not recorded in a timely manner as per procedure.

**Observation 2** notes the absence of adequately established process control procedures for calculating algorithm sensitivity levels. While minimum sensitivity levels for the ZEUS Performance Metrics device (SaMD) were established during FDA clearance in 2019, the firm lacked a procedure for algorithm sensitivity monitoring prior to revision three of the Medical Device Reporting Decision Guidance sheet. The current document, intended for complaint investigators, does