Artificial Intelligence

Artificial Intelligence

USA: FDA – Artificial Intelligence has been broadly defined as the science and engineering of making intelligent machines, especially intelligent computer programs (McCarthy, 2007). Artificial intelligence can use different techniques, including models based on statistical analysis of data, expert systems that primarily rely on if-then statements, and machine learning (source: FDA – Website: Artificial Intelligence and Machine Learning in Software as a Medical Device)

AI, and specifically ML, are techniques used to design and train software algorithms to learn from and act on data. These AI/ML-based software, when intended to treat, diagnose, cure, mitigate, or prevent disease or other conditions, are medical devices under the FD&C Act, and called “Software as a Medical Device” (SaMD) by FDA and IMDRF (source: “Proposed Regulatory Framework for Modifications to Artificial Intelligence/Machine Learning (AI/ML)-Based Software as a Medical Device (SaMD) – Discussion Paper and Request for Feedback”, April 2019)