FDA 510(k) Cybersecurity Documentation

Cybersecurity Documentation Support for 510(k) Submissions

Quality Commercial Consultants (QCC) helps software-enabled medical device and SaMD sponsors prepare the cybersecurity evidence and narratives FDA reviewers expect in a 510(k) submission. We translate your existing artifacts into clear, submission-ready documentation and integrate it into your overall premarket strategy.

Service Summary

Our FDA 510(k) cybersecurity documentation service provides clients with submission-ready cybersecurity artifacts for software-enabled medical devices and Software as a Medical Device (SaMD) undergoing 510(k) premarket notification. Key deliverables include:

  • Regulatory cybersecurity documentation aligned with current FDA expectations for cyber devices.
  • Software Bill of Materials (SBOM) preparation and reviewer-friendly formatting.
  • Cybersecurity risk analysis and threat modeling tailored to your device architecture.
  • Integration of cybersecurity content into eSTAR (or comparable submission templates).
  • Lifecycle vulnerability management documentation, including patch/update strategy and control traceability.

Documentation is developed with a focus on regulatory clarity and traceability, not on creating general security program artifacts.

Regulatory Context and Interpretation

FDA’s cybersecurity expectations for medical devices have continued to mature, with current guidance emphasizing design controls, clear risk-based rationale, and submission-ready evidence for connected and software-enabled devices.

Reviewers increasingly expect sponsors to provide an SBOM, explain how risks are identified and controlled, and describe how vulnerabilities will be monitored and addressed over the product lifecycle.

Although guidance documents are non-binding, they strongly influence review outcomes and the content reviewers request during interactive review.

Relevance to 510(k) Submissions

In FDA 510(k) review, cybersecurity is evaluated as part of device risk, quality, and safety. Strong, well-organized cybersecurity documentation helps:

  • Reduce requests for additional information (AI letters) related to cybersecurity.
  • Increase reviewer confidence in your risk mitigation approach.
  • Demonstrate alignment between design controls, risk analysis, testing evidence, and submission narratives.

If you are approaching a 510(k) submission (or responding to an AI request), we can help you package your cybersecurity evidence into reviewer-ready documentation.

FAQs

Who is FDA 510(k) cybersecurity documentation support for?
This service supports manufacturers of software-enabled or connected medical devices and SaMD preparing an FDA 510(k) submission where cybersecurity documentation is required or expected.
What inputs do you typically need from a sponsor?
Typical inputs include device architecture and software design documentation, third-party component inventories (for SBOM), cybersecurity risk analyses or threat models, existing cybersecurity testing artifacts (if available), and your intended submission format (e.g., eSTAR).
What deliverables do you provide?
Deliverables may include submission-ready cybersecurity narratives, SBOM documentation, risk/threat modeling summaries, lifecycle vulnerability management documentation, and traceability artifacts formatted for FDA review.
Does QCC perform cybersecurity testing?
QCC focuses on regulatory documentation and evidence packaging. We can help interpret and integrate testing results you already have (or plan), but we do not replace a sponsor’s testing execution responsibilities.

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