2024 US RAC Practice Exam

A physician reports to a manufacturer that a patient was hospitalized with acute sepsis after treatment with an approved device. This side effect is not listed in the package insert. This event must be reported by the manufacturer to FDA no later than: A. 5 calendar days. B. 15 calendar days. C. 30 calendar days. D. The next quarterly or annual report. - Explanation: B. There are no 15 day reports included in MDR regulations. 15 Day reports are required b by drug reporting regulations. The correct answer is: C Under the IDE regulation, all of the following must be reported to the sponsor within five working days EXCEPT: A. A deviation from the investigational plan. B. Withdrawal of IRB approval. C. An unanticipated adverse device effect. D. Use of a device without informed consent. - Explanation: B. Withdrawal of IRB approval is reported within five days. The correct answer is C. When design verification testing is being performed by a manufacturer, which element is NOT included as a potential requirement under device design verification section of the QSR?