U.S. Food and Drug Administration (FDA): Artificial Intelligence and Machine Learning in Software as a Medical Device

Artificial intelligence (AI) and machine learning (ML) in software as a medical device (SaMD) in the healthcare field refers to the use of AI and ML technologies to develop software applications that are used to diagnose, treat, or prevent diseases or conditions. These technologies allow software applications to analyze large amounts of data and to make decisions or recommendations based on that analysis.

AI and ML in SaMD in the healthcare field can be used to support a variety of clinical and non-clinical applications. For example, SaMD applications that use AI and ML may be used to analyze medical images, such as X-rays or CT scans, to identify patterns or abnormalities that may indicate a particular disease or condition. They may also be used to analyze data from wearable devices, such as fitness trackers or smart watches, to identify patterns that may indicate a risk for a particular condition or disease.

In order to be classified as a medical device, SaMD applications must meet certain regulatory standards to ensure their safety and effectiveness. As such, the development and deployment of AI and ML in SaMD in the healthcare field is subject to oversight by regulatory bodies such as the US Food and Drug Administration (FDA).

Overall, the use of AI and ML in SaMD in the healthcare field represents a promising area of development that has the potential to improve the accuracy and efficiency of medical diagnoses and treatments.