SaMD, Digital Ecosystems and the New Rules for Cybersecurity

Randy Horton

Published on: September 4th, 2025

Cybersecurity expectations for medical devices just shifted again. On June 27, 2025, the FDA issued its updated Cybersecurity in Medical Devices guidance, expanding requirements for “cyber devices,” clarifying FDORA §524B obligations, and reinforcing expectations around SBOMs, vulnerability disclosure, and update planning.

If you’ve already been working to meet the FDA’s 2023 requirements, you may be asking: What’s different this time? Where has the FDA provided more clarity? And how can you demonstrate “reasonable assurance of cybersecurity” in a world where software-driven devices now operate as part of larger digital ecosystems that include mobile apps, cloud services, and connected care platforms?

Orthogonal and a panel of experts discussed what’s new in the 2025 guidance, compare it to the 2023 version, and provide practical insights you can apply directly to your regulatory and engineering strategies.

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