Understanding FDA Cybersecurity Requirements for Medical Devices and FCA Enforcement, Global Relay Intelligence & Practice

Of counsel Ariel Seeley, associate Jonathan York, and partners Heather Egan and Hannah Levin co-authored an article for Global Relay Intelligence & Practice discussing the June 2025 final guidance from the US Food and Drug Administration (FDA) regarding the agency’s interpretation of and compliance recommendations for new requirements for “cyber devices” under Section 524B of the Federal Food, Drug, and Cosmetic Act.

The authors provide an overview of the FDA’s cybersecurity requirements and recent enforcement actions, key considerations for medical device manufacturers, and how such companies can prepare for a cybersecurity incident.

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