A hardware root of trust anchors selected security functions in hardware-enforced mechanisms and trusted code or key material. Implementations can use ROM-based boot logic, TPMs or secure elements. TrustZone supplies isolation mechanisms but is not by itself a guarantee of immutable code, protected keys or physical tamper resistance. Roots of trust have explicit threat assumptions and may contain exploitable implementation flaws.

Why it matters

Select root-of-trust and key-protection mechanisms through device-specific risk analysis. FDA expects appropriate cybersecurity architecture and key-management evidence, but does not universally require every device to contain a TPM or secure element. Software key storage has limitations that should be evaluated, not treated as automatic regulatory failure.

Common pitfalls

•Calling a software-only secure key store a 'root of trust', without hardware tamper resistance, it isn't.
•Provisioning the same root keys across many devices in manufacturing, per-device unique keys are required for credible device identity.
•Ignoring supply-chain attestation of the secure element itself, a compromised secure element undermines every claim above it.

Sources

NIST SP 800-193: Platform Firmware Resiliency · NIST
TPM 2.0 Library Specification · Trusted Computing Group
FDA - Cybersecurity for Medical Devices · FDA
NIST SP 800-193 · NIST
FDA final guidance, February 3, 2026 · FDA

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Regulatory pathway choice - 510(k) vs PMA, 510(k) vs De Novo, Abbreviated vs Special 510(k).
Quality systems - QSR vs ISO 13485, QMSR vs QSR.
Software classification - SaMD vs SiMD, Locked vs adaptive AI.
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MedTech Terms is a vendor-neutral community resource sponsored by Blue Goat Cyber. Definitions are written for educational use and are not legal or regulatory advice.