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United States ยท medical devices

FDA cybersecurity expectations, made technical

US law now requires medical device makers to address cybersecurity in premarket submissions for cyber devices: a software bill of materials, a plan for monitoring and addressing vulnerabilities, and processes that make the device secure through its lifecycle. The FDA can refuse to accept submissions that skip this.

Who this applies to Manufacturers of devices with software, the makers of software that is itself a device, and the suppliers whose components end up inside either.
What it asks for
A software bill of materials
Machine-readable SBOM covering commercial, open-source, and off-the-shelf components in the device.
Vulnerability monitoring and response
A plan to identify and address postmarket vulnerabilities and exploits, with coordinated disclosure.
Secure development evidence
Processes providing reasonable assurance the device and related systems are cybersecure, documented for review.
How SecuNexa and BOMNexa map to it
SBOM for submission
BOMNexa generates machine-readable SBOMs from actual build artifacts, with support-status context and honest known-unknowns.
Postmarket monitoring
Shipped device versions are re-evaluated automatically as new vulnerabilities are disclosed: the affected-versions answer, on demand.
Secure development substance
Static, dependency, secrets, and configuration analysis in the build pipeline document a working security lifecycle.

Tools do not make you compliant; they make compliance provable. SecuNexa and BOMNexa supply the technical evidence described on this page. Governance, process, and legal interpretation belong to your compliance function, and this page is not legal advice.

Frequently asked questions
Which submissions does this apply to?

Premarket submissions for cyber devices as defined in section 524B of the FD&C Act: broadly, devices with software that can connect to the internet. Your regulatory team owns the determination; the evidence layer is what we automate.

Can this work inside a validated manufacturing environment?

Yes. Everything runs offline as single binaries with deterministic output, which suits validated and change-controlled environments far better than cloud tooling.

Walk through your FDA premarket cybersecurity evidence gaps with us, live.
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