What are the most common FDA cybersecurity deficiencies?

The recurring six: deferred pentest findings rejected, missing test cases per interface, no postmarket vulnerability management plan, incomplete testing history, no recurring penetration testing, and fixes shipped without on-device proof.

Why do FDA cybersecurity deficiencies happen?

Nearly all trace to point-in-time testing and the lack of exploitability management: a single annual test cannot produce the coverage, traceability, and evidence FDA reviewers now expect.

How much delay does a cybersecurity deficiency add?

A deficiency letter typically adds review cycles measured in months. Across 1,000+ cybersecurity submissions we have watched them push ship dates back repeatedly, and in postmarket a few end in recalls.

Explainer

The FDA deficiencies ELTON prevents.

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.

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