Medical Device Cybersecurity Guidance — September 26, 2023

Executive briefing: The U.S. Food and Drug Administration issued its final guidance Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions on 26 September 2023. The document aligns with new statutory obligations under FD&C Act Section 524B and sets detailed expectations for manufacturers seeking clearance or approval.

Core expectations

Secure product design. Manufacturers must document threat modelling, security architecture, cryptography controls, and security risk assessments tied to safety and essential performance.
Software bill of materials. Premarket submissions should provide an SBOM for all software components—including third-party libraries—with vulnerability monitoring procedures.
Vulnerability management. FDA expects coordinated vulnerability disclosure policies, remediation timelines, and postmarket monitoring processes integrated into quality systems.

Action checklist

Update design history files to include cybersecurity risk management artefacts, including traceability from threat scenarios to mitigations.
Establish SBOM tooling and governance covering open-source, commercial, and bespoke software across the device lifecycle.
Align vulnerability response plans with Section 524B requirements for timely updates, patch validation, and customer notification.

Enablement moves

Coordinate with suppliers to secure contractual rights for vulnerability disclosure, patch distribution, and security testing.
Prepare regulatory submission templates that integrate cybersecurity documentation with traditional quality system evidence.
Train regulatory affairs, engineering, and postmarket surveillance teams on FDA’s expectations to avoid review delays.

Sources

Zeph Tech supports medical device teams with SBOM governance, vulnerability response playbooks, and submission-ready cybersecurity documentation.