Software as a Medical Device (SaMD)

Software as a Medical Device refers to software intended to be used for one or more medical purposes that performs those purposes without being part of a hardware medical device. Examples may include software that analyzes medical images or supports a defined clinical decision. Software embedded in a device, software that controls hardware, and general wellness apps may follow different regulatory paths. Classification depends on intended use, claims, functionality, and the law of the market where the software is offered. FDA’s guidance on device software functions distinguishes software functions that are medical devices from those that may not be. A model’s use of machine learning does not itself establish regulatory status. The manufacturer defines intended use and users, evaluates risks, and determines whether premarket authorization or other controls apply. Changes to algorithms, data inputs, or user workflows can affect performance and may require regulatory assessment and change control. Healthcare organizations should verify the product’s labeling, authorization status, supported users and populations, compatible inputs, and limitations. Do not assume that a product authorized for one task or population is suitable for another. SaMD requires quality processes, cybersecurity, post-market monitoring, and clear instructions. This overview explains the concept but does not classify a particular product or replace regulatory advice. A supplier should document the product boundary, including any cloud services, hardware dependencies, and third-party algorithms. Users should also understand whether the output is informational or intended to influence clinical action.