This presentation provides a structured overview of US FDA registration requirements for Software as a Medical Device (SaMD), helping healthtech startups, digital health companies, and medical software developers understand how software products are regulated as medical devices in the United States. As software-driven healthcare solutions continue to grow, understanding FDA expectations is essential for compliant market entry and long-term regulatory success. The document introduces the concept of Software as a Medical Device (SaMD) as defined under FDA guidance and the IMDRF framework, along with common examples such as diagnostic software, clinical decision support tools, and patient monitoring applications. It explains the role of the US Food and Drug Administration (FDA) and the Center for Devices and Radiological Health (CDRH) in regulating medical software products. Key sections describe the risk-based classification system used by the FDA, outlining how device class and intended use influence regulatory obligations. The presentation explains when FDA registration is required, who must comply, and the responsibilities of both domestic and foreign manufacturers marketing SaMD in the US. The presentation also provides an overview of the primary regulatory pathways for SaMD, including 510(k), De Novo, and Premarket Approval (PMA) routes, with attention to software-specific considerations such as lifecycle management, cybersecurity, and validation requirements. Technical and documentation expectations are summarized to help organizations prepare complete and compliant submissions. Common challenges faced during FDA SaMD compliance—such as documentation gaps, clinical evidence requirements, usability considerations, and software update management—are discussed to support proactive regulatory planning. The presentation highlights the importance of expert regulatory guidance in navigating evolving FDA software policies and ensuring efficient submissions. Designed for healthtech startups, digital health companies, medical software developers, and regulatory professionals, this presentation serves as an educational resource for understanding FDA SaMD requirements and building regulatory-ready digital health products. For additional reference on US FDA SaMD registration and regulatory guidance, visit: https://operonstrategist.com/services/regulatory-approvals/samd-registration-with-us-fda/