The Food and Drug Administration (FDA) regulates the most sensitive and impactful medical drugs and substances that the public consumes and utilizes. To ensure public safety they have developed some of the most stringent review and approval procedures. The meticulous steps for bringing a new medical device to market include preclinical research, risk classification, clinical trials, marketing submissions (510(k), PMA, or De Novo), post-market surveillance, and other processes that can take considerable time and resources. With conventional medical devices, this system has been refined and is understood by product makers in the medical industry. The latest technologies, however, utilize advanced software applications, such as artificial intelligence (AI) and machine learning (ML), which are more complicated to review and regulate. The FDA refers to this category as “Software as a Medical Device” (SaMD).
This is a companion discussion topic for the original entry at https://www.edgeimpulse.com/blog/navigating-fdas-ai-guidelines-for-medical-devices-the-edge-impulse-perspective