Security audit
Fda 510k Substantial Equivalence Memo
Security checks for vulnerabilities and agentic risk
Overview
This is a non-executable drafting aid for FDA 510(k) substantial-equivalence memos that clearly keeps outputs as drafts for expert RA/QA review.
Install only if you need FDA 510(k) drafting support. Treat all outputs as draft regulatory work, independently verify current FDA guidance, predicate facts, standards, and test data, and avoid sharing unnecessary confidential device or clinical information.
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
Static analysis
No suspicious patterns detected.