FDA 510(k) Cybersecurity Testing

Cybersecurity Testing & Evidence for FDA 510(k) Submissions

Quality Commercial Consultants (QCC) provides cybersecurity testing and documentation support for medical device companies preparing FDA 510(k) and PMA submissions. We help organizations plan, execute, and document cybersecurity testing activities that align with current FDA premarket expectations and facilitate efficient regulatory review.

FDA views cybersecurity testing as objective evidence that organizations understand cybersecurity risks and implement effective risk control measures. For software-enabled and connected devices, testing activities often include threat modeling, vulnerability assessment, and penetration testing, where appropriate, based on device architecture and risk profile.

QCC supports teams by delivering clear, submission-ready cybersecurity test evidence that demonstrates traceability between identified risks, implemented controls, and verification activities.

Service Summary

Our cybersecurity testing support includes:

  • Cybersecurity test planning aligned with device architecture, attack surface, and cybersecurity risk analysis.
  • Vulnerability assessments and penetration testing scoped to FDA premarket review expectations.
  • Clear documentation describing testing methods, execution, and results.
  • Summaries of cybersecurity testing outcomes linked to identified risks and implemented mitigations.
  • Integration of cybersecurity testing evidence into FDA 510(k) submission formats, including eSTAR.
  • Support for responding to FDA Additional Information requests related to cybersecurity testing.

Our approach scopes penetration testing and related verification activities based on device risk and architecture and documents results in a manner suitable for FDA review, without adding unnecessary complexity or disruption to development processes.

FAQs

Who does cybersecurity testing support apply to?

Cybersecurity testing support applies to:

  • Manufacturers of software-enabled or connected medical devices that include cybersecurity information as part of an FDA 510(k) submission.
  • Regulatory and quality teams that prepare and maintain submission-ready documentation.
  • Engineering and product teams that implement and verify cybersecurity risk control measures.
  • Organizations that seek to align internal cybersecurity testing activities with FDA premarket review expectations.
What inputs are typically required from a sponsor?

Sponsors typically provide inputs such as:

  • Device architecture descriptions and software design documentation.
  • Cybersecurity risk analyses, threat models, or security risk assessments.
  • Existing cybersecurity testing artifacts, including vulnerability assessments and penetration testing results, where available.
  • Intended regulatory pathway and submission format (e.g., eSTAR).
What cybersecurity testing deliverables support an FDA 510(k) submission?

Cybersecurity testing deliverables that support FDA premarket review include:

  • Cybersecurity test plans that define test objectives, scope, and risk-based rationale.
  • Summaries of vulnerability assessment and penetration testing results with traceability to identified risks and implemented risk control measures.
  • Documentation formatted for FDA review, including narrative descriptions, tables, and traceability matrices.
  • Support for integrating cybersecurity testing evidence into the overall FDA 510(k) submission structure.

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