FDA MDR：医疗器械不良事件报告

When must you file an FDA MDR? Under 21 CFR 803, manufacturers report deaths, serious injuries and certain malfunctions linked to their devices. And the clock starts early. For manufacturers, the deadline is 30 calendar days from the day any employee becomes aware. It drops to 5 work days when an event needs remedial action to prevent an unreasonable risk of substantial harm to public health, or when FDA asks in writing. You are not the only reporter. User facilities, such as hospitals, report deaths and serious injuries within 10 work days. Importers have 30 calendar days. And you must fill in what their reports leave out. And for you, there is no paper route. Since August 14, 2015, manufacturers and importers must submit every initial and supplemental MDR electronically, in a format FDA can process, review and archive. Start with three things. One: screen every complaint for reportability. Two: write MDR procedures for evaluating and filing. Three: keep event files for the device's expected life, at least 2 years. Once aware, the clock is running. Pure Global covers registration, in-country representation, quality systems, audits and cybersecurity, in more than 30 markets. Visit pureglobal.com.