Every cybersecurity deficiency we see in FDA review, from deferred pentest findings and interface test cases to vulnerability management and annual testing, with how ELTON closes each from one platform. Step through it below, or open it full screen.
Every finding and every dismissal is evidenced for regulatory review. MDDT-recognized CVSS is produced as an output, not the headline. Proof leads.
Enter your details and the full list opens right here, no download required.
The full list is free. Enter your details on this page and it opens in place, with no download, and a full screen view if you want more room. It walks every cybersecurity deficiency ELTON sees in FDA review and pairs each one with how it is closed.
Yes. Every entry quotes what the Agency writes in review, restates it plainly, and pairs it with the artifact that answers it. The wording comes from cybersecurity submissions ELTON has worked through, not from a generic checklist assembled out of guidance documents.
Both. The same gaps recur across premarket review under Section 524B and across postmarket review. Premarket deficiencies concern test coverage and the evidence behind it. Postmarket deficiencies concern monitoring, recurring testing, and how vulnerabilities are disclosed and patched after clearance.
An FDA cybersecurity deficiency is prevented by producing the evidence before a reviewer asks for it. ELTON runs the testing as a continuous managed program: interface test cases, the threat model, the SBOM, remediation, and per release and annual testing, all kept current, so the gaps never open.
ELTON closes them from a single digital twin, in one service on one platform. That twin derives interface by interface test cases, generates prescriptive remediation down to the code fix, and carries the threat model, SBOM, and risk report, with traceability from CVE to determination that FDA and EU reviewers can follow.