FDA’s Evolving SaMD Regulation: Key Updates for Ophthalmologists
Software as a Medical Device (SaMD) refers to standalone software that performs medical functions (for diagnosis, treatment, monitoring, etc.) without being part of a hardware device. In recent years, such software – especially AI-driven tools – has become widespread in health care. Recognizing the unique risks and innovation potential of SaMD, the FDA (via its Digital Health Center of Excellence) has embarked on a series of new policies and guidance's. In short, the FDA aims to regulate SaMD with a risk-based, life-cycle approach that protects patients while enabling innovation. How FDA Regulates SaMD Today The FDA treats SaMD under its existing medical device laws, using established pathways (510(k), De Novo, or PMA) based on risk. Simply put, if a software function meets the definition of a medical device, it is evaluated like any other device. The FDA focuses oversight on higher-risk software (e.g. diagnostic algorithms) and often exercises enforcement...