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21 CFR Part 803 (MDR) §803.53

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21 CFR Part 803 (MDR): §803.53 If I am a manufacturer, in which circumstances must I submit a 5-day report?

ISO 13485: §8.2.3 Reporting to regulatory authorities

Requirement text

Manufacturers must submit a 5-work-day report when a reportable event necessitates remedial action to prevent an unreasonable risk of substantial harm to public health, or when FDA makes a written request for 5-day reporting. The manufacturer may learn of the need for remedial action from any information source, including trend analysis. Once FDA has made a written request for 5-day reports of a particular type, the manufacturer must continue submitting 5-day reports for all subsequent substantially similar events for the period specified in the request.

21 CFR § 803.53 — current eCFR →

Related clauses

MDR Reporting Requirements — General ObligationsWritten MDR ProceduresMDR Event Files and Records RetentionManufacturer MDR Reporting — Adverse Event Investigation and SubmissionReports of Corrections and RemovalsRecords of Corrections and Removals Not Required to Be Reported

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