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 the day that they receive or otherwise become aware of information, from any source, that reasonably suggests that a device that the manufacturer markets may have caused or contributed to a death or serious injury, or has malfunctioned and this device or a similar device that the manufacturer markets 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.