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  Machine- and human-readable SBOMs with NTIA minimum elements (superseded by CISA's 2026 Minimum Elements for an SBOM, published July 29, 2026), vulnerability mapping, and end-of-support tracking - built for FDA review.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

• FDA PMA Cybersecurity Requirements: Expert Guide (2024)Master FDA PMA cybersecurity requirements. Learn the technical documentation, risk management, and SPDF requirements needed for a successful Class III submissio
• 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.
• 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.
• 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.
• Postmarket Cybersecurity Readiness PlanA three-phase plan, Premarket → Launch → Operate, for the cybersecurity work that starts before your 510(k) is filed, lights up before your first device ships, and runs for the life of the product. Aligned to the FDA February 2026 final guidance.
• ISO 14971 vs AAMI TIR57: Hazard Analysis Meets Cybersecurity RiskHow safety hazard analysis and security risk analysis run in parallel and converge at the patient-harm column, with a side-by-side mapping table.
• Full-Service Cybersecurity for PMA SubmissionsWhat a Class III PMA cybersecurity package needs, and how one integrated team delivers threat modeling, SBOM, pen testing, and the postmarket plan.

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

• PMA Supplement Cybersecurity ChangesWhich PMA submission type a cybersecurity change requires - 180-day supplement, Real-Time, Special, 30-day notice, or annual report - and the decision.
• Letter to File vs New 510(k)When a cybersecurity change to a cleared device stays as a letter to file in the DHF, and when it forces a new 510(k). Decision framework and examples.
• Implantable Device Cybersecurity: Risks, Controls, EvidenceImplantable device cybersecurity has constraints no other device shares: no patch window, limited power, and harm measured in physiology. Here is what to do.
• Modular PMA Submission: What MedTech Teams Need to Know (2026)Modular PMA Submission explained for medical device manufacturers, definition, FDA context, and what teams must document for 2026 submissions.
• 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.
• 510(k) Cost in 2026: FDA Fees, Testing and Consultant SpendWhat a 510(k) really costs: FDA user fees, small business discounts, testing, cybersecurity work and consultant spend, plus how De Novo and PMA costs compare.

Interactive tools

• Pathway crosswalk

  See how PMA cybersecurity evidence expectations differ from 510(k), De Novo, and IDE, side by side.

• eSTAR cybersecurity checklist

  Walk the cybersecurity sections your PMA package has to fill before the acceptance screen.

• Deficiency letter triage

  Classify a PMA cybersecurity deficiency and get the artifact that closes it.

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
• Insufficient Penetration Testing Evidence

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

  Response playbook
• Inadequate Vulnerability Management Plan

  Your VM plan lacks defined triage timelines, a coordinated vulnerability disclosure path, or a documented patch-deploy mechanism.

  Response playbook
• Missing SPDF Documentation

  Reviewers cannot find evidence that your QMS implements a Secure Product Development Framework integrated with design controls.

  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, eSTAR · Same service track: Full-Service FDA Premarket Cybersecurity

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

  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.

  • IEC 81001-5-1 Security Risk Assessment GuideGuideLearn how to implement IEC 81001-5-1 security risk assessments for FDA compliance. Expert guidance on medical device lifecycle security mapping.
  • 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.
  • Post-Quantum Cryptography for Medical Devices (2026)GuideThe quantum-resistant algorithms that matter for medical devices, what they cost in flash and bandwidth, the published migration deadlines, and what the FDA expects in your submission today.

  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