Everything FDA Reviewers Expect in Your Premarket Submission
A comprehensive checklist covering all cybersecurity documentation requirements from FDA's 2025 Premarket Cybersecurity Guidance. Save months of review time and avoid costly information requests.
Every requirement from FDA's 2025 guidance, including all statutory requirements for cyber devices under Section 524B of the FD&C Act.
Priority-Based
Color-coded priority levels help you focus on statutory requirements first, then critical items that will cause submission rejection.
Avoid the 3-6 month delays and $200K-$500K costs that come with FDA Information Requests for missing documentation.
What's Inside The Checklist
Comprehensive coverage of all 9 major documentation areas FDA reviewers evaluate in your premarket cybersecurity submission
Cyber Device Requirements
Complete coverage of Section 524B requirements: Plans & Procedures, SBOM, Processes for Reasonable Assurance, and vulnerability management.
Security Architecture
Required architecture views: Global System, Multi-Patient Harm, Updateability/Patchability, and Security Use Cases with detailed documentation requirements.
Threat Modeling
Device-specific threat identification, attack surface analysis, adversary analysis, and comprehensive threat catalogs using STRIDE framework.
Security Risk Assessment
ISO 14971-compliant cybersecurity hazard analysis, risk evaluation criteria, control effectiveness, and residual risk documentation.
SBOM Documentation
Machine-readable SBOM requirements, NTIA minimum elements, vulnerability assessment against CISA Known Exploited Vulnerabilities, and risk justification.
Security Testing
Penetration testing requirements, vulnerability assessment protocols, security control validation, and wireless security testing methodologies.
SPDF Documentation
Secure Product Development Framework evidence, security requirements integration, design control records, and development lifecycle documentation.
Post-Market Cybersecurity
Vulnerability monitoring programs, patch management processes, coordinated vulnerability disclosure policy, and incident response plans.
Modifications Guidance
Decision tree for cyber device modifications, required vs. abbreviated documentation, and FDA review focus statements.
Standards Compliance
IEC 81001-5-1, IEC 62304, AAMI TIR57/SW96 application guidance and recognized standard documentation requirements.
Labeling Requirements
Cybersecurity information for device labeling, user security guidance, and security update instructions for end users.
Critical Pitfalls to Avoid
Common mistakes that lead to FDA Information Requests or NSE determinations, with specific examples of what NOT to do.
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