Do all 510(k) submissions need cybersecurity documentation?

If your device has software and cybersecurity risk, expect to provide cybersecurity evidence. The depth should scale with connectivity, complexity, and potential impact to safety and effectiveness, consistent with the FDA’s 2026 guidance.

What’s the fastest way to reduce the risk of a cybersecurity deficiency?

Provide a reviewer roadmap plus traceability. Most deficiencies are “missing story” problems, not “one missing control” problems. If you’re already in review, deficiency response support can help you close gaps quickly and present clean evidence.

Is an SBOM required under Section 524B?

For cyber devices, 524B includes SBOM expectations. The FDA’s FAQ page is a helpful starting point, and the 2026 guidance explains how SBOM should be used as part of lifecycle risk management.

Do we need penetration testing?

For many connected devices, yes. The key is to justify scope based on threats and to present results clearly with remediation and retest evidence. If you need an FDA-aligned report structure, see medical device penetration testing services.

How should we handle cybersecurity after clearance?

Run a repeatable postmarket program: monitor, intake, triage, remediate, communicate, and keep documentation current as the product evolves. FDA expects lifecycle capability, and guidance like AAMI TIR97 is a solid reference for postmarket security risk management.

FDA Cybersecurity Requirements for Medical Devices (2026)

Blue Goat Cyber^SMMedical Device Cybersecurity

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