U.S. Food and Drug Administration – FDA Software Documentation: A Risk-Based Shift

The FDA software documentation framework has been updated under the 2023 guidance, replacing the 2005 Level of Concern model with a modern, risk-based structure. This new FDA software documentation approach classifies submissions into Basic and Enhanced levels based on device risk and intended use.

Basic Documentation Level

Applicable to all devices, Basic FDA software documentation includes software description, architecture, SRS, risk management summary, V&V summary, and revision history. IEC 62304 declaration can support compliance.

Enhanced Documentation Level

For Class III and high-risk devices, Enhanced FDA software documentation requires detailed SDS, comprehensive risk management files, unit and integration testing, cybersecurity controls, and full configuration management.

This revised FDA software documentation model strengthens cybersecurity focus, improves clarity, and aligns requirements with real-world risk. Manufacturers must update processes to ensure compliant FDA software documentation, faster approvals, and market readiness.