§803.53. If I am a manufacturer, in which circumstances must I submit a 5-day report? — Inbound Citations

Abbreviated new drug application (ANDA) has the same meaning given the term “abbreviated application” in § 314.3(b) of this chapter.

(iii) Within 5 work days if required by § 803.53.

(h) Five-day report means a medical device report that must be submitted by a manufacturer to us under § 803.53 within 5 work days.

(1) Report to FDA in accordance with §§ 803.50, 803.52, 803.53, and 803.56;

(2) If you are a manufacturer, you are considered to have become aware of an event when any of your employees becomes aware of a reportable event that is required to be reported within 30 calendar days or that is required to be reported within 5 work days because we had requested reports in accordance with § 803.53(b). You are also considered to have become aware of an event when any of your employees with management or supervisory responsibilities over persons with regulatory, scientific, or technical responsibilities, or whose duties relate to the collection and reporting of adverse events, becomes aware, from any information, including any trend analysis, that a reportable MDR event or events necessitates remedial action to prevent an unreasonable risk of substantial harm to the public health.