What FDA Section 524B - Cybersecurity in Medical Devices (2026 Enforcement) requires
Section 524B of the FD&C Act requires manufacturers of cyber devices to design, develop, and maintain processes to ensure cybersecurity throughout the device lifecycle. Key obligations include cybersecurity risk management in the QMS, Software Bill of Materials (SBOM), vulnerability disclosure plans, coordinated disclosure, and postmarket cybersecurity management. Applies to all devices with software or connectivity.
Pillar: Medical & Healthcare · Authority: U.S. Food and Drug Administration (FDA) · Version: 1.0.0 · Last updated:
Primary source: https://www.ecfr.gov/current/title-21/chapter-I/part-820
SHA-256 integrity: a11897695cc09c1ce05832fecfd1e1df08d32d1ce5f28246516f0684e5f31505
Primary Citations — 4 traced to source
- Section 524B of the Federal Food, Drug, and Cosmetic Act
- FDA Guidance: Cybersecurity in Medical Devices (September 2023, updated 2026)
+ 2 more citations (full bibliography, deterministic workflow, actionable schema and crosswalks) included in the vault unlock — $0.01 via Skyfire / L402 / Direct Base USDC.
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