How ELTON Protects from FDA Cybersecurity Audits

The FDA’s cybersecurity guidance demands continuous oversight, documented processes, and defensible vulnerability management across the medical device lifecycle. Many manufacturers struggle during audits because their programs are fragmented—isolated scans, static penetration test reports, and SBOMs that are never maintained. ELTON closes this gap by unifying penetration testing, SBOM monitoring, code and application scanning, and CVE feeds into a single platform. Every vulnerability is tied to product architecture, scored in context, and backed by traceable history. With automated living reports and audit-ready metrics, ELTON eliminates compliance gaps, reduces risk of findings, and ensures manufacturers are prepared for FDA cybersecurity audits.

The Rising Pressure of FDA Cybersecurity Oversight

The FDA’s 2016 Postmarket Cybersecurity Guidance and the 2023/2025 Premarket Cybersecurity Guidance have fundamentally changed the expectations for medical device manufacturers. Cybersecurity is no longer a one-time submission activity; it is a continuous obligation. During audits, the FDA looks for documented processes, traceable evidence, and defensible decisions across the full product lifecycle. Missing records, vague risk acceptance, or inconsistent vulnerability management can all result in findings that delay approvals or jeopardize market access.

Where Manufacturers Struggle

Many manufacturers find themselves unprepared when facing FDA audits because their cybersecurity programs are fragmented. Vulnerability scans are stored in isolated tools. Penetration test results are delivered as static reports. SBOMs are created once but never maintained. Without a unified system of record, it becomes difficult to show continuous monitoring, traceability, or how vulnerabilities were evaluated and resolved.

How ELTON Closes the Gap

ELTON was built to make manufacturers audit-ready. By combining penetration testing, SBOM monitoring, SAST/DAST results, and CVE feeds into a single contextualized platform, ELTON automatically produces the living evidence FDA auditors expect. Every vulnerability is tied to the product’s architecture and scored in context, with traceable history of risk assessments, mitigations, and decisions. Whether the outcome was a fix or a defensible “no-fix” decision, the rationale is recorded and auditable.

Automated FDA-Ready Documentation

One of ELTON’s most powerful advantages is the automation of compliance documentation. Living vulnerability reports, exploitability analysis, coordinated disclosure records, and risk management metrics are continuously updated. This eliminates the scramble to collect evidence during an audit and provides FDA reviewers with a clear, defensible story of how vulnerabilities are identified, triaged, and managed.

Protecting Against Findings and Delays

By aligning directly with FDA guidance, ELTON helps reduce the risk of costly findings. For example, periodic penetration testing, required in both premarket and postmarket guidance, is tracked within the platform. Metrics such as time-to-patch and percentage of patched vulnerabilities are automatically generated. Instead of guessing what the FDA might ask for, ELTON ensures the answers are already prepared.

Conclusion

FDA cybersecurity audits demand proof of continuous, risk-based vulnerability management. With ELTON, manufacturers move beyond fragmented tools and paper-based processes to a defensible, auditable system of record. The result is confidence: confidence in meeting FDA expectations, in avoiding audit findings, and in demonstrating to regulators and customers alike that your medical devices are secure by design and by practice.