Ten document templates covering every cybersecurity requirement for FDA premarket submissions. Threat model, risk assessment, SBOM, CBOM, vulnerability management, patch management, CVD procedure, and more.
Instant download. For QA/RA teams at medical device manufacturers.
The Consolidated Appropriations Act 2023 (Section 524B) made cybersecurity documentation a legal requirement for all premarket device submissions after March 29, 2023. FDA issued its Final Guidance in September 2023.
FDA reviewers are now issuing Refuse to File (RTF) letters for submissions that lack required cybersecurity content — threat model, SBOM, security architecture, vulnerability management plan, and pre-submission checklist. Most QA teams are building these documents from scratch under active submission deadlines.
From premarket submission through post-market monitoring.
FDA Guidance (Sept 2023) × ISO 14971 integration. Covers threat-based risk assessment, CVSS scoring, residual risk evaluation, and risk-benefit documentation. Mapped to Annex B of the FDA guidance and Section 524B of the Omnibus Act.
FDA 2023 Final Guidance Section 3.2 compliant. Structured STRIDE-based threat modeling for medical devices. Covers attack surface analysis, data flow diagrams, trust boundaries, and threat enumeration per FDA expectations.
FDA Section 524B / Cybersecurity Guidance (Sept 2023) compliance template. Covers SBOM format requirements (SPDX/CycloneDX), component inventory, version tracking, known vulnerability mapping, and SBOM maintenance procedures.
FDA Cybersecurity Guidance Section 3.3 compliant. Documents security controls, authentication mechanisms, data encryption, network segmentation, secure communication protocols, and defense-in-depth architecture for premarket submissions.
FDA Cybersecurity Guidance Section 5 post-market requirements. Ongoing vulnerability identification, triage, and remediation procedures. Covers CVE monitoring, severity classification, remediation timelines, and FDA reporting thresholds.
FDA 2023 Final Guidance compliance verification checklist. 100+ checkpoints mapped to Tier 1 and Tier 2 cybersecurity documentation requirements. Use as a pre-submission gate before filing with FDA.
End-to-end patch lifecycle for medical devices. Covers patch identification, risk assessment, testing, deployment, and post-deployment verification. Mapped to FDA Section 5 and IEC 62443 patch management requirements.
CVD policy per ISO 29147/30111 and CISA guidelines. Covers external researcher intake, internal triage, remediation coordination, disclosure timelines, and FDA reporting obligations for exploited vulnerabilities.
Comprehensive security inventory beyond SBOM. Covers cryptographic algorithms, security hardware components, network interfaces, authentication modules, and security-critical firmware. NIST SP 800-53 and FDA guidance aligned.
Ongoing security surveillance for fielded medical devices. Covers threat intelligence feeds, vulnerability scanning cadence, incident response triggers, field safety notice criteria, and FDA MDR/MedWatch reporting thresholds.
The Consolidated Appropriations Act 2023 made cybersecurity submissions mandatory for device submissions after March 29, 2023. FDA is now refusing to accept submissions that lack the required cybersecurity documentation.
These templates reflect the actual structure FDA reviewers expect: threat modeling, SBOM, security architecture, vulnerability management, and post-market monitoring — organized for premarket submission.
FDA cybersecurity documentation takes months to build correctly. Start with the right structure, fill in your device-specific data, and submit with confidence. Regulatory architecture is already here.
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Yes. Section 524B applies to all premarket submissions (510(k), De Novo, PMA, HDE) submitted after March 29, 2023. FDA is currently refusing to file submissions that lack the required cybersecurity content. The checklist (Document 06) maps every required element.
An SBOM (Software Bill of Materials) inventories all software components — open source libraries, third-party modules, OS components. A CBOM (Cybersecurity Bill of Materials) goes further: it includes cryptographic algorithms, hardware security modules, authentication components, and all security-critical elements. FDA guidance references both. Templates 03 and 09 cover each.
FDA distinguishes Tier 1 (higher cybersecurity risk) from Tier 2 (standard) submissions. Tier 2 requires: cybersecurity risk assessment, SBOM, security architecture documentation, vulnerability management plan, and the pre-submission checklist. All Tier 1 requirements plus threat model, CBOM, patch management, and CVD procedure. Document 06 maps which tier applies to your device.
No. This is a practitioner reference toolkit built on the FDA 2023 Final Guidance and Section 524B requirements. Consult your regulatory counsel for formal compliance opinions and submission strategy.
Ten documents. Start with the right structure. Fill in your device data. Submit with confidence.
Also: ISO 14971 Risk Management $247 · EU IVDR Starter Kit $197