Maps to
21 CFR Part 803 (MDR): §803.50 If I am a manufacturer, what reporting requirements apply to me?
ISO 13485: §8.2.3 Reporting to regulatory authorities, §8.2.2 Complaint handling
Requirement text
Manufacturers must report to FDA no later than 30 calendar days after becoming aware of information reasonably suggesting that a marketed device may have caused or contributed to a death or serious injury, or that a device or a similar device that the manufacturer markets has malfunctioned and would be likely to cause or contribute to a death or serious injury if the malfunction were to recur. Manufacturers are responsible for investigating each event, evaluating the cause, and submitting all information reasonably known to them — including information obtainable from the user facility, importer, or other initial reporters.