Postmarket device safety monitoring

Medical devices are central to radiation oncology and include both the hardware and software used to plan and deliver radiotherapy. Most radiation oncology devices do not require preclinical testing to gain United States Food and Drug Administration approval, and therefore postmarket safety monitoring is central to identifying and correcting adverse events related to these devices. In this chapter, we review the standards of postmarket device regulation, including systems for reporting problems, post-approval studies, device recalls, and manufacturer inspections. We also discuss ongoing efforts and future directions in active surveillance for improving existing processes.