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    MandatoryLast updated · Feb 2026 (current final guidance)Verified · 2026-07-16

    FDA Premarket Cybersecurity Guidance & FD&C §524B

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    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

    How to submit in United States

    Playbook reviewed · 2026-07-25

    Submission route

    510(k), De Novo, or PMA with a cybersecurity subsection under section 524B of the FD&C Act

    For a cyber device, FDA expects the cybersecurity subsection to stand on its own: a plan, an SBOM, a threat model, security testing, and evidence that your QMS actually produces secure devices. The February 3, 2026 final guidance supersedes the June 2025 version and aligns closely with the QMSR (21 CFR Part 820 / ISO 13485:2016).

    Authority portal

    Step-by-step

    1. Step 01

      Confirm cyber-device status

      Determine whether the device meets the 524B definition (software + internet-connectable). If yes, the cybersecurity subsection is mandatory, not optional.

    2. Step 02

      Build the Secure Product Development Framework (SPDF) record

      Document security requirements, architecture views, threat model, risk controls, security testing, and post-market monitoring plan. FDA reviewers look for traceability from threat to control to test.

    3. Step 03

      Assemble the SBOM

      Produce a machine-readable SBOM (SPDX or CycloneDX) covering commercial, open-source, and off-the-shelf software, with support status and known vulnerabilities at time of submission.

    4. Step 04

      Draft the Vulnerability Management Plan

      Include coordinated disclosure process, patch cadence, and how you will notify FDA and users of exploitable vulnerabilities post-clearance.

    5. Step 05

      Package the cybersecurity subsection

      Follow the section structure in the Feb 2026 guidance exactly. Reviewers use it as a checklist; missing headings trigger an Additional Information request.

    6. Step 06

      Submit via eSTAR / eCopy

      eSTAR is mandatory for most 510(k)s. Attach the cybersecurity subsection as its own PDF plus the SBOM as a separate machine-readable file.

    Evidence checklist

    Item Level FDA equivalent Notes
    Security risk assessment Required 524B(b)(1) Distinct from safety risk analysis; must address confidentiality, integrity, availability.
    Threat model Required SPDF §V.A.2.2 STRIDE or equivalent, with data-flow diagrams and trust boundaries.
    SBOM (machine-readable) Required 524B(b)(3) SPDX 2.3 or CycloneDX 1.4+, with support / EOL status per component.
    Security testing report Required SPDF §V.A.4 Vulnerability scan, penetration test, fuzzing where applicable, static/dynamic analysis.
    Vulnerability management plan Required 524B(b)(2)
    Cybersecurity labeling Required SPDF §VII
    Interoperability considerations Recommended — Required if the device exchanges data with other systems.

    Common FDA 524B rejections

    SBOM is a spreadsheet, not machine-readable

    Common

    Fix · Export from your build pipeline as SPDX or CycloneDX; the spreadsheet can be a companion document.

    Threat model doesn't map to tested controls

    Common

    Fix · Add a traceability matrix: threat → control → test case → result. Reviewers look for this explicit link.

    No post-market vulnerability monitoring plan

    Common

    Fix · Describe how you will monitor CVEs against your SBOM, patch cadence, and coordinated disclosure contact.

    Cybersecurity subsection missing required headings

    Occasional

    Fix · Mirror the Feb 2026 guidance table of contents verbatim; empty sections with a rationale beat missing ones.

    Typical timeline

    End-to-end window: 6-9 months for a 510(k) with a clean cybersecurity subsection; 9-15 months with an AI request.

    Phase 01

    Pre-submission (Q-sub, optional)

    60-75 days

    Strongly recommended for novel devices or new architectures.

    Phase 02

    eSTAR acceptance review

    15 days

    Phase 03

    Substantive review (510(k))

    90 days FDA clock

    Excludes time on the sponsor for Additional Information responses.

    Phase 04

    Additional Information cycle(s)

    30-180 days

    One AI request is typical; cybersecurity is a top-3 driver of AI requests.

    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).