Software as Medical Devices: requirements and regulatory landscape in the United States

The integration of software into medical devices has profoundly transformed the healthcare landscape, enabling precise diagnostics, personalized treatment , and remote patient monitoring. The rapid pace of software development - especially with artificial intelligence (AI) and machine learning (ML) - demands regulatory frameworks to ensure patient safety, effectiveness, and reliability.

Software as a Medical Device (SaMD) refers to software intended for medical purposes that operates independently of a physical device. This article traces the historical development of regulatory approaches, deconstructs existing frameworks, analyzes challenges and influencing factors, presents case studies, and anticipates future trends. A narrative literature search was conducted using PubMed, Google Scholar, FDA.gov, EUR-Lex and IMDRF.org, covering materials published between January 2013 and May 2025.

The Total Product Lifecycle (TPLC) framework is essential for managing evolving risks and performance of AI/ML-based SaMD. These technologies are redefining regulatory assumptions, requiring systems that ensure transparency, mitigate bias, sustain trust, and promote equitable, safe innovation.