fda-510k-documentation

Pass

Audited by Gen Agent Trust Hub on Sep 21, 2026

Risk Level: SAFENO_CODE
Full Analysis
  • [SAFE]: The skill is a documentation-only resource that facilitates the generation of regulatory artifacts. It does not contain any executable scripts, shell commands, or network operations.
  • [INDIRECT_PROMPT_INJECTION]: The skill acts as a prompt template that ingests external data (software requirements and device descriptions).
  • Ingestion points: User-provided content in the 'Example Usage' section, including device name, product code, and requirements list.
  • Boundary markers: Absent; the prompt interpolation does not use specific delimiters or instructions to ignore embedded commands in the user-provided data.
  • Capability inventory: None; the skill contains no functional code, file-writing capabilities, or network-accessing tools.
  • Sanitization: Absent; the skill does not specify any validation or filtering for user-provided medical requirements.
Audit Metadata
Risk Level
SAFE
Analyzed
Sep 21, 2026, 11:46 AM