iRhythm Technologies, Inc.: FDA Warning Letter (May 25, 2023)

Selected passages from the FDA letter

Quoted FDA text from the published dataset. These selected excerpts are not the complete letter.

Passage 1
Failure to adequately establish and maintain procedures for implementing corrective and preventive action, as required by 21 CFR 820.100(a).

Passage 2
Failure to adequately establish procedures for receiving, reviewing, and evaluating complaints by a formally designated unit, per the requirements of 21 CFR 820.198.

Passage 3
Failure to validate a process to a high degree of assurance per the requirements of 21 CFR 820.75.

Passage 4
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).

Passage 5
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).

Passage 6
Failure to adequately develop, maintain, and implement written MDR procedures as required by 21 CFR 803.17.

Citations in the original letter

As cited in this historical letter, not a statement of current regulatory requirements.

21 CFR 801.109
21 CFR 801.5
21 CFR 801
21 CFR 803.3
21 CFR 803.17(a)(1)
21 CFR 803.50(a)
21 CFR 803.17(a)(3)
21 CFR 803
21 CFR 803.50(a)(1)
21 CFR 803.50(a)(2)
21 CFR 803.17
21 CFR 803.12(a)
21 CFR 806
21 CFR 807.81(b)
21 CFR 820.100(a)
21 CFR 820.198
21 CFR 820.75
21 CFR 820