Security audit
Fda 510k Substantial Equivalence Memo
Security checks for vulnerabilities and agentic risk
Overview
This is a drafting-only FDA 510(k) regulatory memo skill with clear limits and no executable behavior.
Use this as a drafting aid for trained regulatory and quality teams only. It may process sensitive device design and performance information, so provide only appropriate working excerpts and keep final submission decisions with RA/QA leadership.
Vulnerability Patterns
- Skill Instruction HijackingAlters the agent's session goals or safety constraints when the skill loads
- Agent Memory PoisoningWrites attacker-controlled rules into memory that affect later sessions
- Remote Payload Retrieval and ExecutionFetches external code whose behavior can change after review
- Embedded Malicious CodeShips malicious scripts inside the skill and executes them locally
- Unauthorized Access and Privilege EscalationObtains permissions beyond the task's legitimate needs
Vulnerability Patterns
- Prompt InjectionInstruction Override, Hidden Instructions, Exfiltration Commands
- Data ExfiltrationExternal Transmission, Env Variable Harvesting, File System Enumeration
- Privilege EscalationExcessive Permissions, Sudo/Root Execution, Credential Access
- Supply ChainUnpinned Dependencies, External Script Fetching, Obfuscated Code
- Excessive AgencyUnrestricted Tool Access, Autonomous Decision Making, Scope Creep