ABSTRACT
The translation of a sensor technology into clinical medicine is a complex and multifaceted undertaking. This chapter starts with a review of some of the essential considerations involved in the regulatory process, several examples of sensor-based technologies. It mentions some future trends that rely on sensor-based devices, as projected by the FDA. Sensors in medical devices must have rigorous calibration records demonstrating the accuracy of the sensor for the intended use for the duration of a diagnostic or therapeutic procedure. Focusing on medical sensors, there are two primary potential procedural pathways for gaining regulatory certification: 510(k); and premarket approval (PMA). The cochlear implant is a sensor-based technology that evolved over decades, and it was eventually approved as a PMA device. The concept of personalized medicine has not come to pass as rapidly as expected based on the number of encouraging, perhaps overly naïve, press releases describing new patient-specific devices, often based on advanced sensor technology.
