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    FDA / CDRH

    Flag of United StatesUnited States — FDA / CDRH

    MandatoryLast updated · Feb 2026 (current final guidance)Verified · 2026-05-28

    FDA Premarket Cybersecurity Guidance & FD&C §524B

    Authority

    U.S. Food and Drug Administration, Center for Devices and Radiological Health

    Enforced

    Mar 2023

    Legal framework

    FD&C Act §524B + Feb 3 2026 Final Guidance, aligned to QMSR (21 CFR Part 820 / ISO 13485:2016, effective Feb 2 2026). Supersedes Jun 2025 guidance and replaces 2014 premarket cybersecurity guidance.

    FDA package reuse

    ~100%

    Scope

    All cyber devices: software in or as a device, with internet connectivity, that could be vulnerable to cybersecurity threats. Applies to 510(k), De Novo, PMA, HDE and BLA submissions.

    Pre-market

    Cybersecurity treated as part of device safety under the QMSR (ISO 13485:2016). Secure Product Development Framework (SPDF) presented as one way to satisfy QMSR. Threat model, SBOM in machine-readable format, security risk management (AAMI TIR57), security architecture views (global system, multi-patient harm, updateability), security testing.

    Post-market

    Coordinated vulnerability disclosure plan, post-market monitoring, patching commitments and timelines for the supported device lifetime.

    SBOM

    Required

    §524B(b)(3): machine-readable SBOM (SPDX or CycloneDX) with known vulnerabilities and support level for each component.

    Vulnerability disclosure

    Mandatory CVD plan submitted with application. Updates must be free of charge.

    Penalty

    Refusal to Accept (RTA) of submission, adds months to clearance.

    Unique requirements

    • 01Section 524B is statutory, failure = RTA
    • 02Architecture views (global system view, multi-patient harm view, updateability view)
    • 03Free patches for the device lifetime
    • 04Cybersecurity controls must be evidenced through the QMSR / ISO 13485 design controls, not just the submission

    Highlights

    • Cybersecurity = device safety under QMSR (ISO 13485:2016)
    • SPDF positioned as one way to satisfy the QMSR
    • SBOM in machine-readable format
    • Lifecycle security plan with patch SLAs

    Aligns with

    IMDRF N60 (Mar 2020) ISO 13485:2016 (via QMSR) AAMI TIR57 NIST SP 800-30 UL 2900-2-1

    Timeline

    1. Dec 2022

      Omnibus Act adds §524B to FD&C

    2. Mar 29 2023

      RTA enforcement begins

    3. Sep 27 2023

      Final cybersecurity guidance published

    4. Jun 27 2025

      Final guidance updated (supersedes 2023)

    5. Feb 2 2026

      QMSR (21 CFR Part 820 / ISO 13485:2016) takes effect

    6. Feb 3 2026

      Final guidance reissued aligned to QMSR; replaces 2014 premarket cybersecurity guidance and supersedes Jun 2025 version

    Key documents

    Final Guidance (Feb 3 2026): Cybersecurity in Medical Devices — Quality Management System Considerations and Content of Premarket Submissions

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

    Final Guidance PDF (Feb 3 2026)

    https://www.fda.gov/media/119933/download

    Quality Management System Regulation (21 CFR Part 820, effective Feb 2 2026)

    https://www.federalregister.gov/documents/2024/02/02/2024-01709/medical-devices-quality-system-regulation-amendments

    FDA Cybersecurity Hub (Digital Health CoE)

    https://www.fda.gov/medical-devices/digital-health-center-excellence/cybersecurity

    Cybersecurity in Medical Devices: FAQs

    https://www.fda.gov/medical-devices/digital-health-center-excellence/cybersecurity-medical-devices-frequently-asked-questions-faqs

    Postmarket Management of Cybersecurity in Medical Devices

    https://www.fda.gov/regulatory-information/search-fda-guidance-documents/postmarket-management-cybersecurity-medical-devices

    FDA 524B head-to-head

    Related markets

    Frequently asked about United States

    Is SBOM required for medical devices in United States?

    Required. §524B(b)(3): machine-readable SBOM (SPDX or CycloneDX) with known vulnerabilities and support level for each component.

    What does FDA / CDRH require for pre-market cybersecurity?

    Cybersecurity treated as part of device safety under the QMSR (ISO 13485:2016). Secure Product Development Framework (SPDF) presented as one way to satisfy QMSR. Threat model, SBOM in machine-readable format, security risk management (AAMI TIR57), security architecture views (global system, multi-patient harm, updateability), security testing.

    What are the post-market cybersecurity obligations under FDA / CDRH?

    Coordinated vulnerability disclosure plan, post-market monitoring, patching commitments and timelines for the supported device lifetime.

    What is the penalty for non-compliance with FDA / CDRH cybersecurity rules?

    Refusal to Accept (RTA) of submission, adds months to clearance.

    How much of my FDA cybersecurity package is reusable in United States?

    Roughly 100% — an editorial estimate based on overlapping evidence requirements (threat model, SBOM, security risk assessment, pen-test report).