Coordinated Vulnerability Disclosure (CVD)

Services

• FDA Postmarket Cybersecurity

  Once cleared, your device still needs eyes on it. We handle SBOM monitoring, coordinated vulnerability disclosure, patching, and FDA-aligned reporting - delivered as one-off projects or as an annual TPLC Partnership covering an entire product line.

• Postmarket SBOM Monitoring & VEX Automation

  Operational postmarket cybersecurity for cleared medical devices: continuous SBOM diffing against NVD/CISA-KEV/OSV, automated VEX triage, CVE-to-patient-harm risk scoring, and CAPA-ready evidence packs - aligned with FDA postmarket guidance, ANSI/AAMI SW96, and ISO 14971 risk management.

• Legacy Device Protection

  Compensating controls, network isolation, and monitoring for fielded devices that can't be easily updated - keeping clinical operations running without touching the cleared design.

• FDA Premarket Cybersecurity Package

  Full-service: we produce the full cybersecurity documentation set for 510(k), De Novo, PMA, PDP, and HDE submissions under §524B, plus IDE applications under 21 CFR 812 and the FDA's February 3, 2026 premarket guidance - traceable, complete, and current.

In-depth guides

• Postmarket Cybersecurity Readiness PlanA three-phase plan, Premarket → Launch → Operate, for the cybersecurity work that starts before your 510(k) is filed, lights up before your first device ships, and runs for the life of the product. Aligned to the FDA February 2026 final guidance.
• SBOM Vulnerability Management for Medical Devices GuideMaster SBOM vulnerability management for medical devices. Learn to track, triage, and mitigate software risks to meet FDA premarket and postmarket requirements.
• VEX Document Guide for FDA Medical Device ComplianceLearn how VEX documents complement SBOMs for FDA medical device compliance. Expert guidance on Vulnerability Exploitability eXchange for MedTech manufacturers.
• The MedTech Cybersecurity Standards DecoderA plain-English field guide to Section 524B, IEC 81001-5-1, ANSI/AAMI SW96, ISO 14971, and more: what each requires and how they connect in eSTAR.
• Medical Device CVD Guide: FDA Compliance & Best PracticesMaster Coordinated Vulnerability Disclosure (CVD) for medical devices. Learn FDA requirements, ISO/IEC 29147 standards, and how to handle security researchers.
• VDP and CVD Workflows for Medical DevicesHow to build a Vulnerability Disclosure Program (VDP) and Coordinated Vulnerability Disclosure (CVD) workflow for medical devices. ISO/IEC 29147 / 30111, FDA expectations, and a reference SLA model.

Standards & guidance

Defined entries from our MedTech Cybersecurity Standards Glossary.

• AAMI TIR57Principles for Medical Device Security - Risk ManagementThe MedTech-specific extension of ISO 14971 for cybersecurity. Defines how to identify cybersecurity assets, threats, and vulnerabilities, then estimate, evaluate, and control the resulting risk.
• FDA 2026 GuidanceFDA Premarket Cybersecurity Guidance (Feb 3, 2026)The FDA's final premarket cybersecurity guidance, issued February 3, 2026. Provides nonbinding recommendations for cybersecurity documentation and explains Section 524B obligations. It directly supersedes the June 27, 2025 guidance; September 2023 was a final guidance, not a draft.
• SPDFSecure Product Development FrameworkA documented framework that shows security activities are integrated across the device lifecycle - not bolted on at the end. Includes secure requirements, threat modeling, secure coding, V&V, vulnerability management, and post-market response.
• NIST CSF 2.0Cybersecurity FrameworkSix functions: Govern, Identify, Protect, Detect, Respond, Recover. Not MedTech-specific, but commonly used by health-system customers as their procurement bar - so device makers need to map their controls to it.
• ISO 13485Medical Device Quality Management SystemThe international QMS standard for MedTech. Covers design controls, document control, CAPA, supplier management, and post-market surveillance. The QMSR final rule (effective Feb 2, 2026) harmonizes 21 CFR Part 820 with ISO 13485.

From the blog

• Medical Device Vulnerability TestingMedical device vulnerability testing identifies security weaknesses in devices. Protect patients, data, and operations. Learn more from Blue Goat Cyber.

Related FDA deficiencies

The deficiency letters reviewers most often write on submissions in this topic area. Each links to the full response playbook.

• Inadequate Vulnerability Management Plan

  Your VM plan lacks defined triage timelines, a coordinated vulnerability disclosure path, or a documented patch-deploy mechanism.

  Response playbook
• Missing Security Architecture Views

  Your submission is missing one or more of the architecture views FDA 2026 expects (global system, multi-patient, updateability).

  Response playbook
• Insufficient Penetration Testing Evidence

  Reviewers find your penetration test scope too narrow, methodology unclear, or testers insufficiently independent.

  Response playbook
• Insufficient Secure Boot Evidence

  Reviewers want test evidence that secure boot, signed updates, and root-of-trust controls function as claimed.

  Response playbook

Related topics

Adjacent hubs in the same regulatory lifecycle, with the guides, articles, tools, and questions they cover that this hub does not.

• MedTech Cybersecurity StandardsShares AAMI TIR57, FDA 2026 Guidance, SPDF · Same service track: FDA Postmarket Cybersecurity

  The standards MedTech teams actually need are a short list: ISO 14971 for safety risk management, ANSI/AAMI SW96:2023 for security risk management, AAMI TIR57 as its predecessor and companion, IEC 62304 for software lifecycle, IEC 81001-5-1 for secure development, and UL 2900 series where a certification is contractually required.

  • ISO 14971 vs AAMI TIR57: Hazard Analysis Meets Cybersecurity RiskGuideHow safety hazard analysis and security risk analysis run in parallel and converge at the patient-harm column, with a side-by-side mapping table.
  • IEC 81001-5-1 Explained: Health Software Security RequirementsArticleIEC 81001-5-1 explained: the health software security activities it requires, how it builds on IEC 62304, and how it supports an FDA SPDF.
  • IEC 81001-5-1 Security Lifecycle Evidence TableGuidePractical IEC 81001-5-1 evidence mapping: lifecycle activities, artifact owners, review questions, and a worked traceability example for health software.

  Which standards does the FDA actually require?

  The FDA requires compliance with statute (Section 524B) and 21 CFR Part 820 / QMSR. They recognize - but don't strictly mandate - consensus standards like AAMI SW96, IEC 81001-5-1, and ISO 14971. In practice, declaring conformance to those standards is the cleanest path through review.

  More MedTech Cybersecurity Standards FAQs
• FDA Premarket CybersecurityShares FDA 2026 Guidance, SPDF, ISO 13485 · Same service track: FDA Premarket Cybersecurity Package

  FDA premarket cybersecurity review is governed by Section 524B of the FD&C Act (21 U.S.C.

  • FDA Pathway Cybersecurity Differences: 510(k) to PMAGuideHow cybersecurity expectations differ across FDA pathways - 510(k), De Novo, PMA, HDE, IDE, Q-Sub, and PDP - under Section 524B and the February 2026 final guidance.
  • 510(k) Cybersecurity Requirements Every Maker Must MeetArticleFDA 510(k) cybersecurity requirements - threat model, SBOM, testing, postmarket plan - scaled across 510(k), De Novo, and PMA pathways under Section 524B.
  • 12 Reasons the FDA Rejects Cybersecurity SubmissionsGuideThe most common cybersecurity deficiencies in 510(k), De Novo, and PMA submissions, what triggers each one and how to fix it before you file. Aligned to the FDA February 2026 final guidance and Section 524B.

  When does the FDA's 2026 premarket cybersecurity guidance take effect?

  The final guidance is effective February 3, 2026. From that date, eSTAR submissions are screened against the seven-section format defined in the guidance, and missing sections can trigger a Refuse To Accept (RTA).

  More FDA Premarket Cybersecurity FAQs
• IDE CybersecurityShares AAMI TIR57, FDA 2026 Guidance, SPDF · Same service track: FDA Premarket Cybersecurity Package

  Section 524B(a) does not list IDEs, so the statute's premarket cybersecurity content requirements do not attach to an investigational device exemption.

  • IDE Cybersecurity Submission GuideGuideAssemble the cybersecurity content of an IDE application: Appendix 3's five elements, the binding 21 CFR 812.25 requirements behind them, and risk-scaled documentation breadth.
  • FDA IDE Cybersecurity Requirements: 2026ArticleWhat the FDA's Feb 2026 guidance recommends for IDE cybersecurity: informed consent, architecture views, SBOM, labeling, and what's not required yet.
  • Pathway crosswalkToolCompare what IDE, 510(k), De Novo, and PMA each expect on cybersecurity evidence.

  Does Section 524B apply to IDE submissions?

  No. Section 524B(a) enumerates 510(k), De Novo, PMA, PDP, and HDE; an IDE is submitted under a different section of the FD&C Act. Cybersecurity still applies through binding regulation: 21 CFR 812.25 requires the investigational plan to describe the device, the methodology, and the risks to subjects, and the February 3, 2026 guidance describes the cybersecurity content FDA expects there. The distinction matters because the content lands in the investigational plan rather than in an eSTAR cybersecurity section.

  More IDE Cybersecurity FAQs