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21 CFR Part 803 (MDR) §803.10

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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.

21 CFR § 803.10 — current eCFR →

Related clauses

Written MDR ProceduresMDR Event Files and Records RetentionManufacturer MDR Reporting — Adverse Event Investigation and Submission5-Day Expedited MDR ReportsReports of Corrections and RemovalsRecords of Corrections and Removals Not Required to Be Reported

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