iRhythm Technologies, Inc.
6 extracted findings
FDA source excerpt, selected passage
Failure to adequately establish and maintain procedures for implementing corrective and preventive action, as required by 21 CFR 820.100(a).
Findings and supporting evidence
Model-assisted readings, not an exhaustive interpretation. Compare with the extracted source findings below.
Findings extracted from the letter
Selected FDA passages, not the complete letter.
01
Failure to adequately establish and maintain procedures for implementing corrective and preventive action, as required by 21 CFR 820.100(a).
Source passage selected by the model
02
Failure to adequately establish procedures for receiving, reviewing, and evaluating complaints by a formally designated unit, per the requirements of 21 CFR 820.198.
Source passage selected by the model
03
Failure to validate a process to a high degree of assurance per the requirements of 21 CFR 820.75.
Source passage selected by the model
04
Failure to submit a report to FDA no later than 30 calendar days after the day that iRhythm Technologies, Inc., 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, as required by 21 CFR 803.50(a)(1).
Source passage selected by the model
05
Failure to report an MDR for an event where your device has malfunctioned and is likely to cause or contribute to death or serious injury if this malfunction recurred, per the requirements of 21 CFR Part 803.50(a)(2).
Source passage selected by the model
06
Failure to adequately develop, maintain, and implement written MDR procedures as required by 21 CFR 803.17.
Source passage selected by the model
Sections and clauses cited
As cited in this historical letter, not a statement of current regulatory requirements.