Which of the following is not required to be reported to the FDA under the medical device reporting regulation?

The correct choice is that device defects are not required to be reported to the FDA under the medical device reporting regulation. This regulation focuses on serious device malfunctions, patient deaths, and serious injuries that can occur as a result of using a medical device. These events tend to have immediate implications for patient safety and require swift reporting to ensure regulatory oversight and protect public health.

In contrast, while device defects are important to monitor, they do not trigger mandatory reporting unless they are linked to a serious malfunction or have resulted in significant adverse events. Defects on their own may not necessarily cause harm, and thus they do not fall under the same urgency as the other categories. This distinction emphasizes the FDA's focus on events that have a direct impact on patient safety rather than general quality control issues.