Textbook of Digital Health

Dr Chris Paton

← References

Cybersecurity in Medical Devices: Quality Management System Considerations and Content of Premarket Submissions

FDA Center for Devices and Radiological Health (2025)

FDA.

URL: https://www.fda.gov/regulatory-information/search-fda-guidance-documents/cybersecurity-medical-devices-quality-management-system-considerations-and-content-premarket

Abstract. Final FDA guidance issued 27 June 2025, replacing the September 2023 guidance of the same name. Sets out premarket submission expectations for connected 'cyber devices' under section 524B of the Federal Food, Drug, and Cosmetic Act, including a machine-readable software bill of materials (SBOM), security risk management documentation, and update capability.

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