Quick Guide to FDA’s 14 Cybersecurity Documents for Medical Devices

Why are FDA Cybersecurity Documentation Requirements Expanding in 2025?

The FDA’s cybersecurity requirements have transformed dramatically. Medical device manufacturers now face 14 distinct documentation requirements for premarket submissions, a significant increase from just a few years ago. With the June 2025 guidance and mandatory section 524B requirements for cyber devices, understanding these documents is essential for market access.

This guide breaks down each document, shows how they connect, and provides practical strategies for efficient generation. These aren’t standalone deliverables but interconnected pieces that tell your device’s complete cybersecurity story.

What is the Security Risk Management Report and Why is it the Hub Document?

1. Security Risk Management Report

This master document ties everything together. Following ANSI/AAMI SW96 Annex C, it serves as your cybersecurity narrative hub. Include your risk evaluation methods, residual risk conclusions, and mitigation activities. Most importantly, provide clear traceability between your threat model, risk assessment, SBOM, and testing documentation. Think of this as your executive summary that FDA reviewers will reference throughout their evaluation. 

2. Threat Model

Your threat model identifies security objectives, risks, and vulnerabilities across the entire medical device system. Document your assumptions explicitly, for instance, that hospital networks are inherently hostile environments where adversaries control the network. Use established methodologies like STRIDE or the MITRE Playbook. Include supply chain risks, manufacturing vulnerabilities, and decommission activities. This isn’t just about the device itself but the entire ecosystem it operates within. 

3. Cybersecurity Risk Assessment

Unlike safety risk assessments, security assessments focus on exploitability rather than probability. You can’t predict when a hacker will strike, but you can assess how easily they could exploit vulnerabilities. Treat all known vulnerabilities as reasonably foreseeable risks. Use the scoring methods from SW96 Annex F, and remember that exploitability increases over the device lifecycle; what’s difficult to exploit today becomes easier tomorrow as attack methods evolve. 

What Does the FDA Require in a Software Bill of Materials (SBOM)?

4. Software Bill of Materials (SBOM)

For cyber devices, this is mandatory under section 524B(b)(3). Provide a machine-readable SBOM following NTIA baseline attributes. Include all components: proprietary, commercial, open-source, and critically, upstream dependencies. Document the component manufacturer, version, and any known vulnerabilities. This transparency helps healthcare facilities manage their own risk and enables rapid response when new vulnerabilities emerge. 

5. Software Level of Support

For each software component, document the support status and end-of-support dates. Classify components as actively maintained, no longer maintained, or abandoned. This information is crucial for lifecycle planning and helps FDA assess long-term device sustainability. 

6. Safety and Security Assessment of Vulnerabilities

Evaluate each known vulnerability’s impact on device safety and effectiveness. Reference CISA’s Known Exploited Vulnerabilities Catalog; these vulnerabilities must be designed out or have robust compensating controls. For each vulnerability, provide your risk assessment and describe applicable controls in detail. 

7. Assessment of Unresolved Anomalies

Some software defects remain unfixed at submission. Evaluate each anomaly’s security impact, considering relevant Common Weakness Enumeration (CWE) categories. A defect that seems minor from a functionality perspective might be severe from a security standpoint if an attacker can trigger it repeatedly. Document your acceptance rationale for any remaining anomalies. 

Which Cybersecurity Metrics Matter Most to the FDA?

8. Cybersecurity Metrics

Track and report key performance indicators: average time from vulnerability identification to patch release, deployment duration to fielded devices, and percentage of vulnerabilities patched (defect density). These metrics demonstrate your process effectiveness and help FDA assess your ongoing risk management capabilities. 

9. Cybersecurity Controls

Address eight essential categories: Authentication, Authorisation, Cryptography, Code/Data Integrity, Confidentiality, Event Detection/Logging, Resiliency/Recovery, and Updatability/Patchability. Document how each control is implemented and tested. And be sure to use current NIST-recommended cryptographic standards and avoid deprecated algorithms. 

10. Security Architecture Views

Provide four views minimum: Global System View (showing all connections and interfaces), Multi-Patient Harm View (demonstrating isolation between patients), Updateability/Patchability View (showing update mechanisms and fallback procedures), and Security Use Case Views (detailing specific interaction scenarios). These views scale with complexity; a simple USB-connected device needs fewer views than a cloud-connected system. Include detailed diagrams with explanatory text for each view. 

What Types of Cybersecurity Testing Does the FDA Expect?

11. Cybersecurity Testing

Document comprehensive testing beyond standard software validation. Include security requirements verification, threat mitigation testing, vulnerability testing (including fuzz testing and penetration testing), and static/dynamic code analysis. Provide original third-party test reports and your assessment of findings. Indicate tester independence; external penetration testers provide more credibility than internal testing alone. Include your rationale for deferring any findings to future releases. 

How Should Cybersecurity Labelling be Designed for Users and IT Teams?

12. Cybersecurity Management Plan

Required under section 524B(b)(1), this plan outlines your postmarket strategy. Detail your coordinated vulnerability disclosure process, monitoring sources (NIST NVD, security researchers) and response timelines. Distinguish between regular update cycles for known unacceptable vulnerabilities and emergency responses for critical vulnerabilities causing uncontrolled risks. Include patch deployment capabilities and communication strategies. 

13. Cybersecurity Labelling

Provide user-appropriate security information in device labelling. Include network port lists, security configuration instructions, update procedures, and forensic logging capabilities. Make your SBOM available to users, preferably through an online portal with current information. Clearly communicate end-of-support dates and risk transfer procedures. Remember: patients need different information than IT administrators. 

14. Interoperability Risk Assessment

Assess security risks from device interfaces and connections. Common protocols like Bluetooth Low Energy may need additional security layers. Document how your device maintains security when interoperating with other medical devices, hospital infrastructure, and general computing platforms. Address how security controls enable safe information exchange without blocking legitimate user access to their data. 

How can You Streamline the Documentation Process for FDA Cybersecurity Compliance?

Start with security architecture views; they establish the system boundaries and components that inform all other documentation. Your threat modelling builds upon these architectural foundations. Use existing frameworks like IEC 81001-5-1 or the Medical Device and Health IT Joint Security Plan as templates. 

Documentation complexity scales with risk. A standalone thermometer needs simpler documentation than a networked insulin pump. Don’t over-document low-risk devices, but don’t under-document complex systems. 

Maintain rigorous traceability throughout all documents. Each risk identified in your threat model should trace to controls in your architecture, test cases in your validation, and instructions in your labelling.

Consider IDE submissions as practice runs; they require a subset of documents, allowing you to refine your approach before final submission. Leverage existing Quality System processes; these cybersecurity requirements align closely with design controls under 21 CFR 820.30. 

What is the FDA Really Looking for in Cybersecurity Submissions?

These 14 documents work together to demonstrate both compliance with QS requirements and new section 524B obligations for cyber devices. They tell a cohesive story: you’ve identified risks (threat model), assessed them (risk assessment), implemented controls (architecture), validated them (testing), and planned for ongoing management (cybersecurity management plan). 

Remember that reasonable assurance of cybersecurity is now explicitly part of safety and effectiveness. The FDA isn’t looking for perfect security; that’s impossible. They’re looking for thoughtful, systematic risk management with appropriate controls and transparency. 

Start with your Secure Product Development Framework. Build documentation iteratively as you design, test and refine your device. When submission time arrives, you’ll have a comprehensive package that tells your device’s complete cybersecurity story.

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