Description: As cybersecurity requirements become increasingly central to FDA premarket submissions, many manufacturers face challenges translating technical security measures into regulatory-ready documentation. The FDA’s 2023 final guidance on Cybersecurity in Medical Devices outlines comprehensive expectations—but when misunderstood or under-scoped, even well-designed devices can trigger costly submission deficiencies.
This session will use real-world-inspired case studies to highlight common pitfalls in cybersecurity documentation—and how they can derail submissions. We’ll explore examples that include topics on threat modeling, security risk management, labeling, design, SBOMs, and cybersecurity management plans.
Attendees will gain strategic insights into what the FDA is really looking for in cybersecurity documentation and how to ensure submissions reflect the true risk profile of the device. Through each case study, we will identify root causes, FDA reaction, and best-practice remediations. All examples are modified to ensure anonymity but still reflect the lessons to be gained through choices in compiling submissions.
Learning Objectives:
Analyze case-based examples of premarket submissions where cybersecurity documentation gaps led to FDA requests for additional information or delayed review.
Distinguish between adequate and deficient approaches to threat modeling, SBOM development, and security architecture documentation.
Apply best practices for preemptively identifying and resolving weaknesses in cybersecurity documentation to avoid regulatory setbacks.
