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FDA's New Cybersecurity Era: Why SBOMs and Secure Architecture are Non-Negotiable for MedTech by 2026
This episode examines how U.S. FDA regulations have repositioned cybersecurity as a core feature of medical devices. We discuss the impact of the Consolidated Appropriations Act of 2023 and the FDA's "Refuse to Accept" policy, exploring why a secure architecture, a Software Bill of Materials (SBOM), and robust incident response plans are now critical for regulatory approval, hospital trust, and commercial success heading into 2026. - What new authority did the FDA gain over medical device cybersecurity in 2023? - Why is a Software Bill of Materials (SBOM) now a mandatory part of FDA…
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