Maps to
21 CFR Part 803 (MDR): §803.10 Generally, what are the reporting requirements that apply to me?
ISO 13485: §8.2.3 Reporting to regulatory authorities
Requirement text
Device user facilities, manufacturers, and importers must submit reports of adverse events to FDA within specified timeframes. Manufacturers must report deaths, serious injuries, and malfunctions within 30 calendar days of becoming aware. User facilities must report device-related deaths within 10 work days to FDA and the manufacturer, and serious injuries within 10 work days to the manufacturer.