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 individual adverse events within the timeframes that § 803.10 specifies for each, to FDA, to the manufacturer, or to both, as § 803.10 specifies for each. Manufacturers must submit reports of individual adverse events to FDA no later than 30 calendar days after the day they become aware of a reportable death, serious injury, or malfunction. User facilities must submit reports of individual adverse events no later than 10 work days after the day they become aware of a reportable event: reports of device-related deaths to FDA and to the manufacturer, if known, and reports of device-related serious injuries to the manufacturer or, if the manufacturer is unknown, to FDA.