De Novo Cybersecurity Submission Guide

Learn the specific cybersecurity requirements for a successful De Novo submission. Ensure FDA compliance with threat modeling, SBOM, and pen testing.

This guide is written for medical device manufacturers navigating De Novo cybersecurity submission. It is built from real submissions, FDA correspondence, and the standards reviewers actually cite. Use it as a working reference: read straight through, jump to the section that matches your current gap, or hand it to your engineering and regulatory leads as a checklist.

Introduction to De Novo Cybersecurity Requirements

Introduction to De Novo Cybersecurity Requirements is one of the areas FDA reviewers probe hardest in modern submissions. The points below summarize what we ship in client packages and what we have seen FDA accept and reject across 250+ device submissions.

How De Novo Differs from 510(k) Submissions

How De Novo Differs from 510(k) Submissions. Make sure your design history file documents the rationale, the standard you mapped to, and the objective evidence that closes the loop. Reviewers expect to trace the requirement, the test, and the residual risk in a single thread.

The Impact of Section 524B on Novel Devices

The Impact of Section 524B on Novel Devices. Make sure your design history file documents the rationale, the standard you mapped to, and the objective evidence that closes the loop. Reviewers expect to trace the requirement, the test, and the residual risk in a single thread.

Required Cybersecurity Documentation for De Novo Requests

Required Cybersecurity Documentation for De Novo Requests is one of the areas FDA reviewers probe hardest in modern submissions. The points below summarize what we ship in client packages and what we have seen FDA accept and reject across 250+ device submissions.

Security Risk Management Plan and Report

Security Risk Management Plan and Report. Make sure your design history file documents the rationale, the standard you mapped to, and the objective evidence that closes the loop. Reviewers expect to trace the requirement, the test, and the residual risk in a single thread.

Threat Modeling for Novel Architectures

Threat Modeling for Novel Architectures. Make sure your design history file documents the rationale, the standard you mapped to, and the objective evidence that closes the loop. Reviewers expect to trace the requirement, the test, and the residual risk in a single thread.

Software Bill of Materials (SBOM) Requirements

Software Bill of Materials (SBOM) Requirements. Make sure your design history file documents the rationale, the standard you mapped to, and the objective evidence that closes the loop. Reviewers expect to trace the requirement, the test, and the residual risk in a single thread.

Verification and Validation (V&V) for De Novo Devices

Verification and Validation (V&V) for De Novo Devices is one of the areas FDA reviewers probe hardest in modern submissions. The points below summarize what we ship in client packages and what we have seen FDA accept and reject across 250+ device submissions.

Vulnerability Communications and Disclosure Plans

Vulnerability Communications and Disclosure Plans. Make sure your design history file documents the rationale, the standard you mapped to, and the objective evidence that closes the loop. Reviewers expect to trace the requirement, the test, and the residual risk in a single thread.

Penetration Testing Requirements for De Novo Novelty

Penetration Testing Requirements for De Novo Novelty. Make sure your design history file documents the rationale, the standard you mapped to, and the objective evidence that closes the loop. Reviewers expect to trace the requirement, the test, and the residual risk in a single thread.

Postmarket Cybersecurity Considerations for De Novo Classification

Postmarket Cybersecurity Considerations for De Novo Classification is one of the areas FDA reviewers probe hardest in modern submissions. The points below summarize what we ship in client packages and what we have seen FDA accept and reject across 250+ device submissions.

Establishing the Cyber-Device Lifecycle

Establishing the Cyber-Device Lifecycle. Make sure your design history file documents the rationale, the standard you mapped to, and the objective evidence that closes the loop. Reviewers expect to trace the requirement, the test, and the residual risk in a single thread.

Postmarket Management Plan (PMP) Essentials

Postmarket Management Plan (PMP) Essentials. Make sure your design history file documents the rationale, the standard you mapped to, and the objective evidence that closes the loop. Reviewers expect to trace the requirement, the test, and the residual risk in a single thread.

Common Pitfalls in De Novo Cybersecurity Submissions

Common Pitfalls in De Novo Cybersecurity Submissions is one of the areas FDA reviewers probe hardest in modern submissions. The points below summarize what we ship in client packages and what we have seen FDA accept and reject across 250+ device submissions.

Conclusion: Navigating the De Novo Pathway Successfully

Conclusion: Navigating the De Novo Pathway Successfully is one of the areas FDA reviewers probe hardest in modern submissions. The points below summarize what we ship in client packages and what we have seen FDA accept and reject across 250+ device submissions.

How Blue Goat Cyber Approaches De Novo cybersecurity submission

We treat De Novo cybersecurity submission as a regulated engineering workstream, not a one-time document drop. Every engagement is led by senior medical-device security engineers who have shipped 250+ FDA cybersecurity submissions across 510(k), De Novo, PMA, and EU MDR pathways. Here is how we run it end to end:

• Scoping against your device profile. We baseline connectivity, interfaces, data flows, and intended use before we touch a template - because reviewer expectations for a Class II wearable are not the same as a networked hospital platform.
• Standards mapping in writing. Every deliverable is traced to the February 2026 FDA premarket cybersecurity guidance, AAMI SW96, AAMI TIR57 / TIR97, IEC 81001-5-1, and ISO 14971 - with the citation in the artifact itself so reviewers do not have to guess.
• Evidence generated inside your QMS. Threat models, SBOMs, security risk assessments, and test reports are versioned under design controls so the traceability from requirement → test → residual risk holds up under audit.
• Independent testing where it counts. Penetration testing and vulnerability analysis are executed by a testing team that does not also write the design - the separation FDA reviewers increasingly expect on cyber devices.
• Deficiency-ready posture. We anticipate the RTA, AI-letter, and Major deficiency patterns FDA has issued over the past 24 months and pre-empt them in the initial submission, cutting the odds of a second review cycle.
• Postmarket handoff, not abandonment. Every premarket package leaves you with a working postmarket monitoring plan, CVD process, and update cadence so the evidence you shipped stays defensible after clearance.

If you want that treatment applied to your De Novo cybersecurity submission package, our FDA Premarket Cybersecurity Services and FDA Cybersecurity Deficiency Response engagements are the two most common entry points.

Frequently asked questions

What are the cybersecurity requirements for an FDA De Novo submission?

Short answer: De Novo cybersecurity submission is a discrete deliverable inside the Secure Product Development Framework (SPDF). FDA expects it documented, traceable, and version-controlled inside your QMS. For the full context, work through the relevant section above and the linked services below. Every answer here is grounded in current FDA guidance and the standards your reviewer is using.

How does Section 524B affect De Novo classification requests?

Short answer: Treat it as a process, not a one-off document: own the requirement in design controls, map it to a current standard, generate evidence during V&V, and surface the residual risk in your postmarket plan. For the full context, work through the relevant section above and the linked services below. Every answer here is grounded in current FDA guidance and the standards your reviewer is using.

Do I need a full SBOM for a De Novo medical device?

Short answer: Yes. Under Section 524B and the February 2026 final guidance, every cyber device requires the artifact in question. Skipping it is the fastest way to an RTA hold. For the full context, work through the relevant section above and the linked services below. Every answer here is grounded in current FDA guidance and the standards your reviewer is using.

How is threat modeling different for a De Novo device vs a 510(k)?

Short answer: The two are complementary, not interchangeable. Use this guide's comparison table to decide which one your submission needs and where the overlap saves you re-work. For the full context, work through the relevant section above and the linked services below. Every answer here is grounded in current FDA guidance and the standards your reviewer is using.

What happens if the FDA issues a cybersecurity deficiency for my De Novo?

Short answer: It depends on the device classification, intended use, and connectivity profile. But the controlling references are FDA's February 2026 premarket guidance, AAMI SW96, and IEC 81001-5-1. The sections above walk through how each applies. For the full context, work through the relevant section above and the linked services below. Every answer here is grounded in current FDA guidance and the standards your reviewer is using.

Does a De Novo submission require independent penetration testing?

Short answer: Yes. Under Section 524B and the February 2026 final guidance, every cyber device requires the artifact in question. Skipping it is the fastest way to an RTA hold. For the full context, work through the relevant section above and the linked services below. Every answer here is grounded in current FDA guidance and the standards your reviewer is using.

Where this fits in the cluster

This page sits downstream of our pillar resources on De Novo cybersecurity submission. If you arrived here from a different starting point, these are the most useful adjacent pages:

• FDA Premarket Cybersecurity Services
• FDA Cybersecurity Deficiency Response
• The SPDF Playbook for FDA-Ready Medical Devices
• 12 Reasons the FDA Rejects Medical Device Cybersecurity Submissions

Related from Blue Goat Cyber

• Medical Device Threat Modeling
• FDA-Compliant SBOM Services
• Medical Device Penetration Testing
• FDA Cybersecurity Deficiency Letter Response Checklist
• Secure MedTech Product Design Consulting

Sources & primary references

• Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions. U.S. Food and Drug Administration (FDA)
• De Novo Classification Process (Evaluation of Automatic Class III Designation). U.S. Food and Drug Administration (FDA)
• Principles and Practices for Medical Device Cybersecurity. International Medical Device Regulators Forum (IMDRF)
• ANSI/AAMI SW96:2023 Standard for Medical device security. Security risk management for device life cycle. AAMI/ANSI

Talk to a regulatory cybersecurity team

If you are working through De Novo cybersecurity submission and want a second pair of eyes on your submission package, we ship cybersecurity deliverables for medical device manufacturers across 510(k), De Novo, PMA, and EU MDR pathways. Book a discovery session and we will walk your evidence with you.