FDA Submission AI Questions The FDA’s 2023 and 2025 cybersecurity guidance highlight recurring deficiencies, including missing threat models, inadequate testing evidence, unsupported software, and lack of traceability. ELTON addresses these challenges through digital...
Automating FDA Cybersecurity Compliance with ELTON
Summary
ELTON empowers medical device manufacturers to meet FDA cybersecurity requirements from development through postmarket support by providing an end-to-end vulnerability management solution. Fully aligned with both the 2016 postmarket and 2025 premarket FDA guidance, ELTON automates critical activities like periodic penetration testing, SBOM monitoring, CVE triage, and contextual vulnerability scoring. By combining multiple discovery methods—including fuzzing, SAST/DAST, and architecture-aware analysis—ELTON delivers a continuous, product-specific security posture. Its intelligent, posture-based approach reduces unnecessary patching by identifying root causes and exploit chains, resulting in fewer fixes, lower cost, and stronger regulatory compliance.
Medical device manufacturers face increasing pressure to meet evolving FDA cybersecurity expectations. ELTON was designed to help companies achieve compliance across both premarket and postmarket requirements while reducing unnecessary patching through smarter, context-aware vulnerability management. By combining automated tooling, continuous monitoring, and product-specific analysis, ELTON supports the full spectrum of regulatory obligations—helping teams comply with the 2016 FDA postmarket guidance and the 2025 FDA premarket requirements from development through the entire product lifecycle.
FDA Postmarket Guidance (2016)
The FDA’s 2016 postmarket cybersecurity guidance requires manufacturers to implement structured processes for identifying, assessing, and managing vulnerabilities after release. Key expectations include monitoring vulnerability sources such as SBOMs and threat intelligence, applying consistent vulnerability scoring and triage, and deploying timely patches for issues that present uncontrolled risk. Periodic penetration testing is also required to confirm the effectiveness of security controls. ELTON enables these processes with automated SBOM-driven CVE monitoring, contextual CVSS scoring, and living vulnerability reports that update as products and threats evolve.
FDA Premarket Guidance (2025)
The 2025 guidance expands on this foundation by requiring a comprehensive vulnerability management SOP as part of submissions. It also reinforces the need for penetration testing both premarket and postmarket. ELTON ONE addresses these requirements in full by providing phased penetration testing, SAST/DAST, fuzzing, and SBOM generation during development, then transitioning into continuous monitoring, CVE triage, and re-analysis throughout the lifecycle.
Smarter Patching, Defensible Decisions
What makes ELTON unique is its ability to minimize patch fatigue. Instead of blindly fixing all HIGH or CRITICAL issues, ELTON evaluates vulnerabilities in architectural context. A LOW-severity issue that enables a HIGH-severity exploit may be a more impactful target. This system-level analysis allows manufacturers to apply fewer patches, address root causes, and still meet FDA expectations while strengthening security.
A Path Forward
In a regulatory environment where patient safety, reliability, and compliance are non-negotiable, ELTON provides a smarter, more defensible approach. By aligning with both the 2016 and 2025 FDA cybersecurity guidances and automating the most difficult aspects of vulnerability management, ELTON helps manufacturers remain compliant, reduce costs, and build confidence with regulators and customers alike.
