Maps to
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. If a manufacturer receives a written request from FDA for the submission of a 5-day report, the manufacturer must submit, without further requests, a 5-day report for all subsequent events of the same nature that involve substantially similar devices for the time period specified in the written request.