In June 2025, the US Food and Drug Administration (FDA) issued a final guidance titled Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions (2025 Cybersecurity Guidance). This guidance updates the 2023 guidance of the same title with the agency’s interpretation of and compliance recommendations for(FDDCA)
Understanding FDA cybersecurity requirements for medical devices and FCA enforcement
5 min read
Key considerations for medical device manufacturers and how to prepare for a cybersecurity incident.