A physician reports acute sepsis in a patient treated with a device. When must the manufacturer report this event to the FDA?

The requirement for medical device manufacturers to report adverse events to the FDA is governed by specific regulations that dictate timelines based on the severity and nature of the event. In the case of acute sepsis, which is categorized as a serious adverse event, the manufacturer must report this incident to the FDA within 30 calendar days. This timeframe is established to ensure that serious issues related to the safety and efficacy of medical devices are promptly communicated, allowing the FDA to assess risks and take necessary actions to protect public health.

This 30-day reporting period is consistent with the FDA's guidelines for mandatory reporting under the Medical Device Reporting (MDR) requirements, as acute sepsis is a critical situation that could significantly impact patient safety. The choice of 30 days reflects the need for thorough investigation and preparation of the report while still acting in a timely manner to inform regulatory authorities.