Inside The FDA's New Cybersecurity Expectations For Premarket Submissions

They had the science. They had the predicate. What they didn’t have was a clean cybersecurity file.

The MedTech startup’s novel diagnostic platform was on the brink of FDA submission. But buried in an internal folder marked “Prelim_Cyber” was a mismatched threat model, a software bill of materials (SBOM) with outdated component names, and no lifecycle update plan. Days before the deadline, they discovered the architectural diagrams didn’t match the attack surface listed in their narrative. It wasn’t just a setback—it was a warning.

This scenario isn’t rare anymore. It’s the emerging norm.

In June 2025, the U.S. Food and Drug Administration (FDA) finalized a transformative update to its cybersecurity guidance for medical devices. Cyber documentation is no longer a supporting player—it’s a centerpiece of regulatory approval. For companies submitting 510(k), premarket approval (PMA), or De Novo files, failure to meet cybersecurity expectations could halt their product before it ever reaches the market.

And the shift isn’t limited to the U.S. The European Medicines Agency (EMA) is pursuing its own parallel transformation. Its 2025–2028 work plan includes AI observatories, international regulatory AI guidance, and digital academy training—all underlining that compliance and digital fluency are now inseparable.

Your FDA Guidance Documents Strategy Just Became Make Or Break

Finalized on June 26, 2025, the FDA’s guidance document, “Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions,” marks a regulatory inflection point. It not only replaces the 2023 final guidance and the 2024 draft update, but also fully activates the agency’s expanded authority under Section 524B of the Federal Food, Drug, and Cosmetic Act (FD&C Act). For the first time, FDA reviewers can reject medical device submissions based solely on inadequate or disorganized cybersecurity documentation, regardless of safety or efficacy data.

The scope of the new guidance is broad and unambiguous. Any medical device containing software or programmable logic—whether it connects to the internet or not—now falls under these cybersecurity requirements. This extends beyond traditionally "connected" products to include software-driven tools with USB ports, Bluetooth modules, or embedded networking components.

Critically, cybersecurity responsibilities are no longer limited to the device itself; they extend to the entire system. The guidance expands accountability to the full “medical device system”—including update servers, supporting infrastructure, and networked components. Companies must now address system-wide risks, data flows, and lifecycle controls across the entire digital ecosystem that supports their device.

This isn’t just more paperwork—it’s a structural overhaul of how cybersecurity is integrated into submission strategy.

Cyber Documentation Pitfalls That Derail Submissions

The 2025 guidance establishes five mandatory documentation requirements that represent a significant expansion from previous cybersecurity expectations:

1. Inconsistent or Human-Readable SBOMs

SBOM documentation is now mandatory for all submissions under Section 524B. Manufacturers must identify all software components, including commercial, open-source, and off-the-shelf elements. 

FDA reviewers routinely flag submissions where SBOM entries use inconsistent naming conventions (e.g., “Win 2K” vs. “Windows 2000”), lack software versioning, or omit component metadata. Even when teams attempt to comply, SBOMs submitted as PDFs or spreadsheets are often incompatible with machine-readable expectations. A compliant SBOM should use standardized naming schemas (e.g., SWID, SPDX), be updated continuously during development, and maintain traceability across risk, testing, and architecture documents. Otherwise, review teams cannot confidently validate known vulnerabilities.

2. Mismatched Threat Models and Diagrams

Threat modeling has evolved from a recommended practice to a mandatory submission component. Manufacturers must identify attack surfaces, vulnerabilities, and specific mitigation strategies. The documentation must align with Secure Product Development Framework (SPDF) concepts, demonstrating a systematic approach to identifying and addressing potential security risks.

One of the most common and preventable errors occurs when threat models fail to align with product architecture. In some cases, threat models refer to subsystems that don’t appear in any diagram or use outdated attack surfaces from earlier product versions. To avoid confusion, diagrams should be annotated to show where identified threats appear, and mitigation strategies must be explicitly traced to those threat surfaces.

3. Missing Security Architecture Views

The FDA requires four distinct architecture views: a system-level diagram, a data flow diagram, a trust boundary map, and a threat surface model. Each must demonstrate how design mitigations address cybersecurity risks. Submissions missing even one of these—or using inconsistent labeling across documents—often receive deficiency letters. Reviewers expect clearly labeled layers that show authentication checkpoints, encrypted communications, and access controls. Visual alignment with the threat model is critical to pass scrutiny.

4. No Patch Management or Lifecycle Security Plan

Post-market vulnerability management is now a regulatory requirement, not a nice-to-have. FDA guidance emphasizes “secure by design” principles, meaning companies must demonstrate how they will monitor, detect, and remediate security threats throughout the product lifecycle. Common gaps include lack of a vulnerability disclosure policy, vague timelines for software updates, or failure to assign responsibility for ongoing security maintenance. Without a structured lifecycle security plan, reviewers will flag the submission as incomplete.

5.  Disjointed Documentation Systems

Static folders and manually versioned documents are the root cause of many submission issues. Reviewers frequently encounter references to documents that were not included or inconsistencies between architecture diagrams, SBOMs, and threat models. Disconnected PDF files, lacking metadata or version tracking, create friction during regulatory review and increase the risk of misalignment. Without a centralized system to track dependencies and updates, teams often submit outdated or mismatched documents, leading to unnecessary delays.

Why Global Regulatory Updates Are Creating Chaos in Documentation

International compliance is only adding complexity. The EMA’s Network Data Steering Group (NDSG) is now launching workstreams on AI governance, analytics, and interoperability. Meanwhile, EU MDR classification creates overlapping expectations around lifecycle risk management and software safety. These parallel regulatory developments create a complex web of requirements that medical device manufacturers must navigate simultaneously.  

For startups submitting in multiple markets, this means:

• Managing asynchronous guidance timelines

• Reconciling FDA’s SPDF approach with EMA's lifecycle documentation

• Aligning with emerging global AI standards

Traditional folder-based document management systems are unable to handle the version control, traceability, and audit logging requirements now expected for cybersecurity files. Threat models, SBOMs, architecture diagrams, and regulatory guidance documents are often disconnected across teams, creating gaps that regulatory reviewers increasingly flag as deficiencies. Interoperability, traceability, and real-time updates are the new baseline.

Real Attacks Are Driving These Compliance Changes

The urgency around cybersecurity compliance isn't just regulatory—it's driven by real-world threats that continue to escalate. High-profile incidents, such as the 2024 Change Healthcare breach, which disrupted billing systems for months, and the Henry Schein attack that impacted over 29,000 individuals and resulted in $350-400 million in lost sales, demonstrate the financial and operational risks associated with inadequate cybersecurity.

Attack tactics have evolved from those of casual hackers to those of sophisticated nation-state actors and ransomware cartels. Medical devices often serve as entry points to larger hospital systems, making them attractive targets for economically motivated adversaries. As Kevin Fu, former FDA cybersecurity lead and current professor at Northeastern University, notes: "This is no longer child's play. These are economically motivated adversaries."

The regulatory response has been equally dramatic. The FDA no longer needs to tie poor cybersecurity to traditional "safety and effectiveness" concerns. If cybersecurity documentation is inadequate, the agency can now reject submissions based solely on poor "cyber hygiene."

Smart Companies Are Building Tomorrow's Compliance Today

The evolution of cybersecurity guidance represents a permanent shift in regulatory expectations, not a temporary increase in documentation requirements. Medical device manufacturers must build a compliance infrastructure that can adapt to evolving threats, changing regulatory requirements, and increasing documentation complexity.

Success requires moving beyond reactive compliance approaches to proactive systems that anticipate regulatory changes and maintain continuous readiness for submission updates or modifications. Companies that invest in sophisticated regulatory information systems now will be better positioned to navigate future guidance updates and maintain a competitive advantage in an increasingly complex regulatory environment.

As Kevin Fu notes about legacy technology challenges: "Legacy tech is poured in concrete. We're waiting for the foundations to collapse." The same principle applies to regulatory documentation systems—companies still relying on folder-based approaches are building on foundations that cannot support the dynamic, traceable, and comprehensive documentation requirements of modern cybersecurity compliance.

The FDA Is Going AI While You're Still Using Email Attachments

The regulatory landscape is being simultaneously transformed by the integration of artificial intelligence at the FDA itself. The agency is rolling out generative AI to accelerate review timelines, potentially reducing review periods from days to minutes for certain documentation components. The FDA has appointed a Chief AI Officer and is expanding AI capabilities across all Centers.

This technological transformation at the regulatory level creates both opportunities and challenges for medical device manufacturers. Companies that can leverage AI-powered regulatory information systems will be better positioned to meet the FDA's accelerated review expectations while maintaining comprehensive documentation standards.

The EMA is pursuing similar AI initiatives, with plans to publish an AI observatory report, host annual workshops, and develop International Council for Harmonisation (ICH)-aligned global guidance. This parallel development means that regulatory guidance management systems must be sophisticated enough to handle multiple regulatory frameworks simultaneously.

What This Means for Every MedTech Startup

For MedTech startups, cybersecurity compliance represents both a significant challenge and a competitive opportunity. Investor due diligence now includes cybersecurity documentation quality as a key risk factor, as poor documentation directly correlates with higher regulatory risk and potential submission delays.

The data integrity challenges that caused 75% of Abbreviated New Drug Application (ANDA) delays in 2024, according to FDA's Darby Kozak, illustrate how documentation problems can derail otherwise solid submissions. Startups with limited internal resources often underinvest in documentation systems until regulatory problems emerge, creating costly delays and potentially compromising market entry timing.

A structured approach to regulatory guidance management can reduce rework, increase submission success rates, and avoid common deficiencies that trigger FDA questions or delays. The investment in proper documentation systems early in the development process pays dividends throughout the product lifecycle.

Don’t Let Documentation Chaos Kill Your Next Submission

A fully integrated digital platform tailored explicitly for regulatory intelligence offers immediate access to personalized regulatory updates, document management, and real-time compliance tracking. Such platforms utilize centralized databases, sophisticated search capabilities, and automated document tagging to streamline regulatory workflows and facilitate cross-functional collaboration.

Technical features typically include advanced indexing and tagging mechanisms, AI-driven predictive analytics dashboards, and integrated collaborative tools enhancing communication and coordination.

Actionable steps for digital platform integration:

• Select and implement specialized regulatory intelligence management platforms that align with your business needs.

• Integrate these platforms directly into existing project management systems and workflows.

• Continuously update system capabilities in response to evolving regulatory requirements and internal user feedback.

• Regularly conduct usability assessments and solicit user feedback to optimize platform functionality and user experience.
  

Strategic Success Builds On Intelligent System Integration

The competitive separation is accelerating. MedTech leaders leveraging structured regulatory intelligence are not only achieving faster approvals and streamlined operations—they're fundamentally changing how quickly they can respond to market opportunities. Companies still dependent on manual processes are discovering that "falling behind" has become "being left out entirely."

This represents more than operational improvement—it's strategic repositioning. You're establishing the digital backbone that transforms regulatory complexity from a bottleneck into a competitive moat, enabling rapid international expansion and market responsiveness that manual processes simply cannot match.

Contact us today to discuss how we can transform your regulatory approach and build the documentation infrastructure your submissions deserve. Together, we can ensure your cybersecurity compliance strategy positions your organization for long-term regulatory success.