The regulatory pathway for an IVD depends on its risk level, with options such as 510(k) submissions, premarket approvals, and de novo classifications. In addition to premarket submissions, the FDA conducts post-market surveillance of IVDs to monitor their safety and effectiveness after they have been …

Meanwhile, according to Frazier et al. 4, robots are often programmed with sophisticated sensors, transmitters, and receivers as essential components. Moreover, robot computer systems are integrated with a display device, which has data sensing programs generated through the patient’s condition. A robot functions in such …