SaMD

Software as a Medical Device (SaMD) refers to software that is intended to be used for one or more medical purposes and performs its medical function without being part of a hardware medical device. SaMD can run on general purpose computing devices such as smartphones, tablets, or personal computers, and may include standalone decision-support algorithms, image analysis, or AI-based diagnostic tools. It is distinct from software that is itself embedded in a medical device hardware component.

Regulatory landscape: Internationally, the IMDRF defines SaMD and provides framework for risk categorization and regulatory oversight. Regulatory requirements vary by jurisdiction. In the United States, the Food and Drug Administration regulates SaMD as a medical device, with risk-based classification and premarket pathways (510(k), De Novo, or PMA), along with quality management, post-market surveillance, and cybersecurity requirements. In the European Union, software that meets the definition of a medical device is regulated under the Medical Devices Regulation (MDR) or In Vitro Diagnostic Regulation (IVDR) with conformity assessment and CE marking. Other regions have analogous regimes.

Standards and lifecycle: Development follows software life-cycle processes aligned with ISO 14971 for risk management and IEC 62304 for software life cycle processes. IEC 82304-1 provides health software product safety requirements. Post-market activities include monitoring, software maintenance, vulnerability management, and updates that may require regulatory notification.

Examples and considerations: Examples include mobile apps that analyze images for disease detection, rhythm analysis from wearables, or clinical decision-support tools. Key considerations include effectiveness and safety, data privacy and interoperability, explainability where feasible, and ongoing cybersecurity and software maintenance.