Medtronic, Inc.

Selected passages from the FDA letter

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

Passage 1

You failed to adequately establish procedures for corrective and preventive action, as required by 21 CFR 820.100(a).

Passage 2

You failed to review, evaluate, and investigate complaints involving the possible failure of a device to meet any of its specifications, as required by 21 CFR 820.198(c).

Passage 3

Your firm failed to submit a report to FDA no later than 30 calendar days of receiving or otherwise becoming aware of information that reasonably suggests that a marketed device may have caused or contributed to a death or serious injury, as required by 21 CFR 803.50(a)(1).

Passage 4

Your firm failed to submit a report to FDA no later than 30 calendar days after the day that the firm received or otherwise became aware of information, from any source, that reasonably suggests that a device that the firm markets has malfunctioned and this device or a similar device that it markets would be likely to cause or contribute to a death or serious injury, if the malfunction were to recur, as required by 21 CFR 803.50(a)(2).