510(k) Cybersecurity

Services

• Full-Service FDA Premarket Cybersecurity

  Full-service, end-to-end: we deliver 100% of the artifacts FDA reviewers expect 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.

• FDA Deficiency Response

  Rapid-response team that resolves FDA cybersecurity deficiencies on the first resubmission - across 510(k), De Novo, PMA, and HDE.

• Medical Device Threat Modeling

  Comprehensive threat modeling per FDA Section V.A.1 - covering supply chain, deployment, environment of use, and decommission risks for the full device system.

• FDA-Compliant SBOM Services

  Machine- and human-readable SBOMs with NTIA minimum elements (superseded by CISA's 2026 Minimum Elements for an SBOM, published July 29, 2026), vulnerability mapping, and end-of-support tracking - built for FDA review.

• Medical Device Penetration Testing

  Hardware, firmware, mobile, and cloud - tested by operators with both red-team and medical-device experience. Reports built for FDA reviewers.

In-depth guides

• Cybersecurity for IVD Devices: The FDA & Section 524B GuideHow Section 524B and AAMI SW96 apply to clinical analyzers, point-of-care, and connected IVD platforms, plus the pitfalls IVD teams hit.
• Combination Product Cybersecurity: When CDER Meets CDRH §524BHow Section 524B and the Feb 2026 guidance apply to drug-device combination products, including the CDER/CDRH lead-center split.
• FDA Cybersecurity Technical Screening Checklist (2026)A reviewer's-eye technical screening checklist for FDA cyber-device submissions: artifacts, formats, traceability, and the failure modes that turn a soft deficiency into a hold.
• eSTAR v7.1 Cybersecurity Attachments Mapped to 2026 GuidanceHow to package the 18 cybersecurity deliverables into 8 named attachment groupings in eSTAR v7.1, with the most common RTA trigger for each grouping.
• FDA Premarket Cybersecurity Submission Checklist GuideEnsure your 510(k) or PMA is compliant. Use our checklist for FDA premarket cybersecurity submissions, covering SBOM, threat models, and pen testing.
• FDA Pathway Cybersecurity Differences: 510(k) to PMAHow cybersecurity expectations differ across FDA pathways - 510(k), De Novo, PMA, HDE, IDE, Q-Sub, and PDP - under Section 524B and the February 2026 final guidance.
• 12 Reasons the FDA Rejects Cybersecurity SubmissionsThe most common cybersecurity deficiencies in 510(k), De Novo, and PMA submissions, what triggers each one and how to fix it before you file. Aligned to the FDA February 2026 final guidance and Section 524B.
• FDA Cybersecurity Deficiency Response ChecklistA step-by-step, 11-stage checklist for organizing and resolving FDA cybersecurity deficiency letters across 510(k), PMA, De Novo, and HDE submissions. Aligned to the FDA February 2026 final guidance and Section 524B.
• FDA Cybersecurity Requirements for Medical Devices (524B)FDA cybersecurity requirements for medical devices under Section 524B: the SBOM, SPDF evidence and postmarket vulnerability plan every cyber device submission needs.
• The MedTech Cybersecurity Standards DecoderA plain-English field guide to FDA Section 524B, IEC 81001-5-1, AAMI TIR57, ANSI/AAMI SW96, ISO 14971, and 8 more medical device cybersecurity standards, what they require, how they connect, and what FDA expects in your eSTAR premarket submission.
• How to Pass FDA 510(k) Cybersecurity on the First SubmissionThe cybersecurity package that clears 510(k) review without an AI letter: eight artifacts, common rejection patterns, and a 30-day readiness check.
• FDA Penetration Testing Scope: 510(k), De Novo, PMA, & IDEHow to scope penetration testing for an FDA submission so the report survives reviewer scrutiny: attack surfaces, evidence depth, and scope by pathway.

Standards & guidance

Defined entries from our MedTech Cybersecurity Standards Glossary.

• FDA 2026 GuidanceFDA Premarket Cybersecurity Guidance (Feb 3, 2026)The FDA's final premarket cybersecurity guidance, effective February 3, 2026. Defines the seven-section cybersecurity submission format reviewers now enforce at Technical Screening, replacing the 2023 draft. Operationalizes Section 524B of the FD&C Act.
• Section 524BFD&C Act Cyber Device RequirementsSection 524B of the FD&C Act (the statutory partner to 21 CFR 807.81) was added by the Consolidated Appropriations Act, 2023. It gives the FDA explicit authority to require a complete cybersecurity package in every premarket submission for a cyber device, and to refuse submissions that lack one. It works alongside 21 CFR 807.81, which sets the 90-day 510(k) filing floor.
• eSTARElectronic Submission TemplateFDA's mandatory interactive submission template with structured upload slots for each cybersecurity artifact.
• SPDFSecure Product Development FrameworkA documented framework that shows security activities are integrated across the device lifecycle - not bolted on at the end. Includes secure requirements, threat modeling, secure coding, V&V, vulnerability management, and post-market response.
• ANSI/AAMI SW96Medical Device Security Risk ManagementThe consensus standard for medical device security risk management - asset, threat, vulnerability, likelihood, severity, and residual risk acceptability.
• ISO 14971Medical Device Risk ManagementThe umbrella risk-management standard for medical devices. Defines hazard identification, risk estimation, risk evaluation, risk control, and residual risk evaluation. Cybersecurity risks must be reconciled here so a security control never silently introduces a safety hazard.

From the blog

• 510(k) Cybersecurity Requirements Every Maker Must MeetFDA 510(k) cybersecurity requirements - threat model, SBOM, testing, postmarket plan - scaled across 510(k), De Novo, and PMA pathways under Section 524B.
• Indications for Use, Predicates, and Cybersecurity ScopeHow your Indications for Use statement and predicate choice change the cybersecurity scope of a 510(k): use environment, harm ceiling, pen test scope, and Special 510(k) eligibility.
• Home Use vs Hospital Device Cybersecurity RequirementsHome use vs hospital device cybersecurity: which controls the HDO environment provides, which the device must carry itself, and how the FDA reviews each case.
• Does Device Class Decide FDA Cybersecurity Scope?Class I, II, III doesn't decide your FDA cybersecurity burden. Section 524B's cyber-device test and whether you file a premarket submission do.
• FDA SIR Cybersecurity Response: eSTAR Prep GuideFDA Submission Issue Request (SIR) response strategy for cybersecurity: eSTAR prep checklist, common 524B gaps, and how to answer without restarting review.
• FDA 510(k) & PMA Cybersecurity GuideSearch the FDA 510(k), De Novo, and PMA databases for cybersecurity precedent, product codes, and predicate devices before a Section 524B premarket filing.

Interactive tools

• Letter to File vs SIR vs Special 510(k) crosswalk

  Map a security-relevant change to the right pathway and see the cybersecurity evidence each decision requires.

• SIR response builder

  Draft a structured cybersecurity response to a Submission Issue Request, section by section, before the clock runs out.

Related FDA deficiencies

The deficiency letters reviewers most often write on submissions in this topic area. Each links to the full response playbook.

• Incomplete Threat Model

  Reviewers say your STRIDE/attack-tree analysis misses interfaces, trust boundaries, or post-market threat surfaces.

  Response playbook
• Missing Security Architecture Views

  Your submission is missing one or more of the architecture views FDA 2026 expects (global system, multi-patient, updateability).

  Response playbook
• Insufficient Penetration Testing Evidence

  Reviewers find your penetration test scope too narrow, methodology unclear, or testers insufficiently independent.

  Response playbook
• Missing Cybersecurity Risk Assessment

  Reviewers cannot find a cybersecurity risk assessment distinct from the ISO 14971 safety risk file, or the integration is unclear.

  Response playbook

Related topics

Adjacent hubs in the same regulatory lifecycle, with the guides, articles, tools, and questions they cover that this hub does not.

• PMA CybersecurityShares FDA 2026 Guidance, Section 524B, eSTAR · Same service track: Full-Service FDA Premarket Cybersecurity

  PMA cybersecurity is the same Section 524B content set as any other pathway, applied at greater depth because Class III devices are life-sustaining or life-supporting.

  • FDA PMA Cybersecurity Requirements: Expert Guide (2024)GuideMaster FDA PMA cybersecurity requirements. Learn the technical documentation, risk management, and SPDF requirements needed for a successful Class III submissio
  • PMA Supplement Cybersecurity ChangesArticleWhich PMA submission type a cybersecurity change requires - 180-day supplement, Real-Time, Special, 30-day notice, or annual report - and the decision.
  • eSTAR cybersecurity checklistToolWalk the cybersecurity sections your PMA package has to fill before the acceptance screen.

  How is PMA cybersecurity different from a 510(k)?

  PMA cybersecurity packages go deeper on every section. Threat models cover safety-critical clinical scenarios end-to-end, not just connected interfaces; pen testing typically includes white-box review of safety-critical firmware paths; the postmarket plan must defend the device through its full intended lifetime, not just the next clearance cycle. Reviewers also issue more cybersecurity deficiencies on PMAs than on any other pathway, so the bar for evidence quality is higher.

  More PMA Cybersecurity FAQs
• FDA Premarket CybersecurityShares FDA 2026 Guidance, Section 524B, eSTAR · Same service track: Full-Service FDA Premarket Cybersecurity

  FDA premarket cybersecurity review is governed by Section 524B of the FD&C Act (21 U.S.C.

  • The SPDF Playbook: Secure Product Development FrameworkGuideA practical, ungated guide to building a Secure Product Development Framework (SPDF) that FDA accepts, the eight pillars, the artifacts each one produces, and a pre-submission readiness checklist you can score yourself against.
  • 21 CFR Part 820 and Medical Device CybersecurityArticle21 CFR Part 820 explained: the 2026 QMSR shift to ISO 13485, what changed, and how design controls, CAPA, and Section 524B evidence connect.
  • EU MDR vs FDA Cybersecurity: Side-by-Side CrosswalkGuideHow EU MDR/IVDR cybersecurity requirements compare to FDA Section 524B and the February 2026 guidance - Annex I §17.2, MDCG 2019-16, SBOM, vulnerability handling, and postmarket obligations.

  When does the FDA's 2026 premarket cybersecurity guidance take effect?

  The final guidance is effective February 3, 2026. From that date, eSTAR submissions are screened against the seven-section format defined in the guidance, and missing sections can trigger a Refuse To Accept (RTA).

  More FDA Premarket Cybersecurity FAQs
• IDE CybersecurityShares FDA 2026 Guidance, Section 524B, SPDF · Same service track: Full-Service FDA Premarket Cybersecurity

  Section 524B(a) does not list IDEs, so the statute's premarket cybersecurity content requirements do not attach to an investigational device exemption.

  • IDE Cybersecurity Requirements: Investigational Device GuideGuideWhat cybersecurity documentation an IDE application needs under 21 CFR 812 and the FDA February 3, 2026 premarket guidance, and why Section 524B does not apply.
  • FDA IDE Cybersecurity Requirements: 2026ArticleWhat the FDA's Feb 2026 guidance recommends for IDE cybersecurity: informed consent, architecture views, SBOM, labeling, and what's not required yet.
  • IDE Cybersecurity Submission GuideGuideAssemble the cybersecurity content of an IDE application: Appendix 3's five elements, the binding 21 CFR 812.25 requirements behind them, and risk-scaled documentation breadth.

  Does Section 524B apply to IDE submissions?

  No. Section 524B(a) enumerates 510(k), De Novo, PMA, PDP, and HDE; an IDE is submitted under a different section of the FD&C Act. Cybersecurity still applies through binding regulation: 21 CFR 812.25 requires the investigational plan to describe the device, the methodology, and the risks to subjects, and the February 3, 2026 guidance describes the cybersecurity content FDA expects there. The distinction matters because the content lands in the investigational plan rather than in an eSTAR cybersecurity section.

  More IDE Cybersecurity FAQs