IDE Cybersecurity

Services

• FDA Premarket Cybersecurity Package

  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.

• 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.

• Medical Device Penetration Testing Services

  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.

• Medical Device SBOM Services

  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.

In-depth guides

• IDE Cybersecurity Submission GuideAssemble 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.
• 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 Critical Threat-Modeling Gaps in SubmissionsA practical, ungated guide to the threat modeling gaps that trigger FDA cybersecurity questions in 510(k), De Novo, and PMA submissions - and exactly how to close them before reviewers find them.
• The SPDF Playbook: Secure Product Development FrameworkA 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.
• The MedTech Cybersecurity Standards DecoderA plain-English field guide to Section 524B, IEC 81001-5-1, ANSI/AAMI SW96, ISO 14971, and more: what each requires and how they connect in eSTAR.

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, issued February 3, 2026. Provides nonbinding recommendations for cybersecurity documentation and explains Section 524B obligations. It directly supersedes the June 27, 2025 guidance; September 2023 was a final guidance, not a draft.
• 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.
• ANSI/AAMI SW96Medical Device Security Risk ManagementThe consensus standard for medical device security risk management, asset, threat, vulnerability, likelihood, severity, and residual risk acceptability.
• AAMI TIR57Principles for Medical Device Security - Risk ManagementThe MedTech-specific extension of ISO 14971 for cybersecurity. Defines how to identify cybersecurity assets, threats, and vulnerabilities, then estimate, evaluate, and control the resulting risk.
• 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.
• 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.

From the blog

• FDA IDE Cybersecurity Requirements: 2026What the FDA's Feb 2026 guidance recommends for IDE cybersecurity: informed consent, architecture views, SBOM, labeling, and what's not required yet.
• Threat Modeling Connected & Implantable DevicesMedical device threat modeling steps: scoping, data flow diagrams, STRIDE, ISO 14971 harm scoring, and what FDA reviewers expect in a submission package.
• Medical Device Safety vs Security RisksExplore the critical distinctions between safety and security risks in medical devices. Aligned with the FDA's Feb 3, 2026 premarket cybersecurity guidance.

Interactive tools

• Pathway crosswalk

  Compare what IDE, 510(k), De Novo, and PMA each expect on cybersecurity evidence.

Related FDA deficiencies

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

• Insufficient Penetration Testing Evidence

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

  Response playbook
• Insufficient Secure Boot Evidence

  Reviewers want test evidence that secure boot, signed updates, and root-of-trust controls function as claimed.

  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

Related topics

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

• 510(k) CybersecurityShares FDA 2026 Guidance, Section 524B, ANSI/AAMI SW96 · Same service track: FDA Premarket Cybersecurity Package

  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.

  • Cybersecurity for IVD Devices: The FDA & Section 524B GuideGuideHow Section 524B and AAMI SW96 apply to clinical analyzers, point-of-care, and connected IVD platforms, plus the pitfalls IVD teams hit.
  • 510(k) Cybersecurity Requirements Every Maker Must MeetArticleFDA 510(k) cybersecurity requirements - threat model, SBOM, testing, postmarket plan - scaled across 510(k), De Novo, and PMA pathways under Section 524B.
  • SIR response builderToolDraft a structured cybersecurity response to a Submission Issue Request, section by section, before the clock runs out.

  How is 510(k) cybersecurity different from De Novo or PMA?

  The seven-section cybersecurity package the FDA expects is the same across 510(k), De Novo, and PMA - the differences are scope and depth. 510(k) reviewers focus heavily on substantial equivalence to a predicate, so the threat model and risk assessment have to show that any new connectivity, software, or interfaces don't change the safety profile in a way the predicate didn't address. PMA goes further on manufacturing and quality-system evidence; De Novo allows special controls that can include cybersecurity-specific requirements.

  More 510(k) Cybersecurity FAQs
• MedTech Cybersecurity StandardsShares FDA 2026 Guidance, Section 524B, ANSI/AAMI SW96 · Same service track: FDA Premarket Cybersecurity Package

  The standards MedTech teams actually need are a short list: ISO 14971 for safety risk management, ANSI/AAMI SW96:2023 for security risk management, AAMI TIR57 as its predecessor and companion, IEC 62304 for software lifecycle, IEC 81001-5-1 for secure development, and UL 2900 series where a certification is contractually required.

  • ISO 14971 vs AAMI TIR57: Hazard Analysis Meets Cybersecurity RiskGuideHow safety hazard analysis and security risk analysis run in parallel and converge at the patient-harm column, with a side-by-side mapping table.
  • IEC 81001-5-1 Explained: Health Software Security RequirementsArticleIEC 81001-5-1 explained: the health software security activities it requires, how it builds on IEC 62304, and how it supports an FDA SPDF.
  • IEC 81001-5-1 Security Lifecycle Evidence TableGuidePractical IEC 81001-5-1 evidence mapping: lifecycle activities, artifact owners, review questions, and a worked traceability example for health software.

  Which standards does the FDA actually require?

  The FDA requires compliance with statute (Section 524B) and 21 CFR Part 820 / QMSR. They recognize - but don't strictly mandate - consensus standards like AAMI SW96, IEC 81001-5-1, and ISO 14971. In practice, declaring conformance to those standards is the cleanest path through review.

  More MedTech Cybersecurity Standards FAQs
• PMA CybersecurityShares FDA 2026 Guidance, Section 524B, ANSI/AAMI SW96 · Same service track: FDA Premarket Cybersecurity Package

  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