Core principles of building secure products from the ground up.
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On June 27, 2025, the US Food and Drug Administration (FDA) published a landmark update to its premarket cybersecurity guidance, superseding the version from September 2023. This new document provides critical clarity for medical device manufacturers by consolidating previous guidances and formally defining the legal obligations for "cyber devices" under Section 524B of the FD&C Act.
On November 20, 2024, the Cyber-Resilience Act (CRA) was officially published in the EU's Official Journal as Regulation (EU) 2024/2847. This marks the final, formal step in a legislative process that will fundamentally reshape the market for connected devices.
The UK's Ministry of Defence (MOD) recently published a thought-provoking document via its Defence Science and Technology Laboratory (Dstl) that every product security leader should read: the Secure by Design Problem Book.
Welcome to the SecureByDesignHandbook.com project!