Cybersecurity in Medical Devices

The FDA’s Cybersecurity in Medical Devices: Quality Management System Considerations and Content of Premarket Submissions provides updated recommendations for incorporating cybersecurity into the design, development, risk management, testing, documentation, and lifecycle management of medical devices. The guidance applies broadly to devices with software, firmware, programmable logic, or other cybersecurity considerations and explains how manufacturers should address cybersecurity in premarket submissions. It emphasizes secure-by-design development, threat modeling, cybersecurity risk assessments, Software Bills of Materials, security architecture, penetration and vulnerability testing, labeling, patching, coordinated vulnerability disclosure, and postmarket cybersecurity management. The guidance also explains statutory requirements for “cyber devices” under section 524B of the Federal Food, Drug, and Cosmetic Act and aligns cybersecurity practices with FDA’s Quality Management System Regulation.