FDA Medical Device Cybersecurity Guidance (2026 Revision)
Authority type
Federal Agency Guidance
Jurisdiction
United States
Issuing body
Food and Drug Administration
Citation
FDA, Cybersecurity in Medical Devices: Quality Management System Considerations and Content of Premarket Submissions (final guidance issued Feb. 3, 2026; supersedes the June 27, 2025 version)
Legal status
Final Guidance Issued
Last reviewed
Provides comprehensive guidance on quality system documentation, threat modeling, security architecture design, and postmarket patch monitoring for connected medical robotics. The 2026 revision aligns the guidance with FDA's Quality Management System Regulation.
