510(k) is the most common FDA premarket pathway for cyber-enabled devices, and it's also where most cybersecurity deficiencies surface. The Feb 2026 final guidance and Section 524B raised the bar on what reviewers expect to see in the seven-section eSTAR cybersecurity package. This hub pulls together the services, guides, blog posts, standards, and FAQs that cover what a 510(k)-grade cybersecurity submission looks like - and the deficiency patterns we see most often when one isn't.
The short answer
A 510(k) cybersecurity package for a cyber device includes the SPDF narrative, threat model, security risk assessment tied to ISO 14971, machine-readable SBOM with VEX, security architecture views, penetration and vulnerability testing evidence, postmarket monitoring plan with coordinated vulnerability disclosure, and cybersecurity labeling. Predicate cybersecurity evidence does not transfer; you must generate device-specific artifacts. Missing items trigger a Refuse to Accept decision at the acceptance screen rather than a deficiency later.
Full-service: we produce the full cybersecurity documentation set for 510(k), De Novo, PMA, PDP, and HDE submissions under §524B, plus IDE applications under 21 CFR 812 and the FDA's February 3, 2026 premarket guidance - traceable, complete, and current.
Cybersecurity gap analysis, evidence updates, and point-by-point responses for manufacturer review across 510(k), De Novo, PMA, and HDE.
Comprehensive threat modeling per FDA Section V.A.1 - covering supply chain, deployment, environment of use, and decommission risks for the full device system.
Medical device SBOM services with source, build, and binary evidence reconciliation, component vulnerability assessment, and support-status verification. SPDX by default; fixed fee after scoping.
Medical device penetration testing services across agreed hardware, firmware, wireless, app, and cloud attack paths. Threat-traced Test Plan, Test Cases, and Test Report for FDA submission documentation.
Defined entries from our MedTech Cybersecurity Standards Glossary.
The deficiency letters reviewers most often write on submissions in this topic area. Each links to the full response playbook.
Reviewers say your STRIDE/attack-tree analysis misses interfaces, trust boundaries, or post-market threat surfaces.
Response playbookYour submission is missing one or more of the architecture views FDA 2026 expects (global system, multi-patient, updateability).
Response playbookReviewers find your penetration test scope too narrow, methodology unclear, or testers insufficiently independent.
Response playbookReviewers cannot find a cybersecurity risk assessment distinct from the ISO 14971 safety risk file, or the integration is unclear.
Response playbook30-minute strategy session. No cost, no commitment - just answers from people who've supported 275+ FDA submissions, with zero cybersecurity rejections.
