FDA medical device classification — regulatory class and controls for a device type. Search by device name or FDA product code; returns device class (I/II/III), CFR regulation number, medical specialty/review panel, official definition, and flags for life-sustaining/support, implant, GMP-exempt, ...
AI agents call medical.device-classification to retrieve information from Mcp without modifying anything — typically the context-gathering step in research, monitoring, and reporting workflows, before the agent takes action elsewhere.
This is a pure data retrieval tool that queries a public regulatory database. It performs a search/lookup operation with no capability to create, modify, delete, execute code, or commit financial transactions. The severity is low because misuse (e.g., an agent querying for device classifications) poses minimal risk — the data is public and immutable via this interface.
From the tool's definition Tool retrieves FDA classification data (device class, CFR regulation number, medical specialty, official definition, flags) by searching device name or product code.
Attacks that exploit this kind of access
FDA medical device classification — regulatory class and controls for a device type. Search by device name or FDA product code; returns device class (I/II/III), CFR regulation number, medical specialty/review panel, official definition, and flags for life-sustaining/support, implant, GMP-exempt, third-party-review. Free, public-domain FDA data. It is categorised as a Read tool in the Mcp MCP Server, which means it retrieves data without modifying state.
Register the MCP server in PolicyLayer and add a rule for medical.device-classification: allow, deny, rate-limit, or require approval. Point your MCP client at the PolicyLayer proxy URL and the rule is enforced on every call, before it reaches Mcp. Nothing to install.
medical.device-classification is a Read tool with low risk. Read-only tools are generally safe to allow by default.
Yes. Add a rate_limit block to the medical.device-classification rule in your PolicyLayer policy. For example, setting max: 10 and window: 60 limits the tool to 10 calls per minute. Rate limits are tracked per agent session and reset automatically.
Set action: deny in the PolicyLayer policy for medical.device-classification. The AI agent will receive a policy violation error and cannot call the tool. You can also include a reason field to explain why the tool is blocked.
medical.device-classification is provided by the MCP server (@2sio/mcp). PolicyLayer sits as a proxy in front of this server to enforce policies before tool calls reach the server.
Every MCP server has a record like this.
Type a name, get the same breakdown: verified identity, auth posture, risk grade, capabilities, recommended policy.
Teams ship this data inside their own products. See what a licence covers →