This FDA final guidance (2023) specifies required documentation content for software in premarket submissions including 510(k), PMA, and De Novo pathways. The guidance provides structured requirements based on software risk level (minor, moderate, major) classification, recognizing that documentation scope should be proportionate to patient risk. For each software risk category, the document delineates specific submission requirements for design specifications, system architecture, verification and validation (V&V) documentation, cybersecurity considerations, and unmet need summaries. Manufacturers must provide detailed design specifications describing intended functionality and performance parameters, system architecture documentation explaining software structure and interfaces, comprehensive V&V documentation demonstrating safety and effectiveness testing, and cybersecurity management plans addressing relevant threats. The guidance replaces the previous "Content of Premarket Submissions for Software" document, incorporating contemporary regulatory expectations including artificial intelligence considerations, interoperability requirements, and cybersecurity standards. Compliance with these content requirements streamlines FDA review and supports timely device approval decisions.